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How CMS is Following VA’s Lead on Informed Consent

August 25, 2017
by Aaron S. Fink, M.D.
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The frequently quoted adage “the more things change, the more they stay the same” was first penned by a French journalist in 1849. Now over 150 years later, this view seems applicable to today’s healthcare environment.  By way of example, even in this time of tremendous change, the Centers for Medicare & Medicaid Services (CMS) is now addressing an issue that the Department of Veterans Affairs (VA) addressed over a decade ago.

This latest example of national policy mirroring VA practice is the Quality of Informed Consent Documents Measure, which CMS is proposing to add to its Hospital Inpatient Quality Reporting (IQR) program. In the measure’s methodology report, CMS states that “most informed consent documents do not meet a minimum patient-centered standard to support informed decision-making.” Yet as early as 2002, the VA identified concerns within its own informed consent policies and processes that parallel many of those now targeted by CMS.

At that time, in addition to recognizing the significant role the consent process plays in shared decision-making, the VA also understood its business implications—especially delays in operating room (OR) start times caused by misplaced paper consent forms. In response to those concerns, the VA launched its Electronic Support for Patient Decisions (ESPD) initiative in 2004.

Fortunately, today’s health systems can readily implement changes to address the lessons the VA learned as it examined its consent processes during the ESPD implementation. Such changes can not only meet the proposed IQR measure, but can also strengthen the commitment to shared decision-making.

Following the VA’s Example

CMS notes that although comprehensive informed consent documents enhance patient comprehension and satisfaction, they are seldom given to patients early enough or with sufficient detail and explanation to encourage their involvement in formulating their care plans. The VA came to a similar conclusion, in part due to studies such as Hospital Informed Consent for Procedure Forms: Facilitating Quality Patient-Physician Interaction, which showed that most consent forms failed to contain the basic elements required for adequate informed consent.  As such, these forms appeared designed to authorize treatment and protect providers from liability rather than providing critical information needed to help patients make better health decisions.

Aaron S. Fink, M.D.

Mindful of such research, during its ESPD program the VA considered a software approach to support the informed consent process. The goal of this approach was to automate and standardize the informed consent process to ensure consistent provision of detailed, easy-to-understand, procedure-specific consent documents for the thousands of services and procedures performed in VA medical centers.

At the time of the ESPD program (2004), the VA’s VistA Computerized Patient Record System (CPRS) was arguably one of the best EHR infrastructures available. This system allowed the VA to deploy an automated solution for generating and documenting consents within its EHR. Obviously, since that time the nationwide proliferation of EHRs has facilitated widespread use of automated consent tools in hospitals and practices outside the VA.

Deployment of such automated consent solutions offers several critical benefits in achieving compliance with the Quality of Informed Consent Documents Measure. First, the measure requires providers to enter detailed language describing the procedure, the reason for performing the procedure, the risks, benefits and alternatives. Software that draws on a database of previously-vetted consents offers a practical solution for reproducibly generating comprehensive and legible forms (the measure proposes an additional point if the content is typed) specific to the proposed treatment.

The second way automation can aid compliance with the measure involves timing. In the proposed measure, 25 percent of the score is earned by obtaining and documenting the patient’s consent at least one day before the procedure occurs. As CMS has realized, the time consent is obtained has proved to be a crucial factor when seeking to enhance shared decision-making via informed consent. In fact, as my colleagues and I have reported, the time spent in the consent discussion is one of the most powerful predictors of patient comprehension. We found that the optimal amount of time for the conversation was 15 to 30 minutes—an amount of time that usually isn’t practical in a rushed pre-op environment.


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