More Process over Substance

William HymanWilliam A. Hyman
Professor Emeritus, Biomedical Engineering
Texas A&M University,
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Recently I addressed here the issue of physicians having to use certain functions of their EHR even if they didn’t need those functions to accomplish the desired outcome. Notably, it is required under Meaningful Use to have certain prompts occur whether or not those prompts are necessary for the user to do what the prompt is telling them to do, and in turn whether or not the prompts change any behaviors while also not adding to prompt fatigue.

A similar CMS requirement, recently postponed from a start date of January 2017, addresses physicians ordering advanced imaging studies in the out-patient environment consistent with certain practice guidelines, or “appropriate use criteria” (AUC for those working on their acronym glossary). These AUCs are being developed by potentially overlapping medical specialty societies. Imaging providers would then have to require that ordering physicians had at least considered the AUCs. But the requirement here is not just to apply the guidelines, but to apply them using a computerized Clinical Decision Support system (CDS). Thus it will not be acceptable to be in compliance as a result of using your own knowledge of the guidelines, or even looking at them on paper or on line, or by using a manual check list. The only acceptable route to compliance will be to use CDS software, and that software will have to be CMS certified based in turn on CMS recognized AUCs. This will not immediately mandate doing what the CDS says you should do, but ordering physicians who are identified as non-compliant outliers will be subject to an as yet not described prior authorization process. Such outliers will be reported to CMS by the imaging providers, no doubt building an interesting relationship between the ordering physicians and the radiology practices.

The objective of this requirement, created by a 2014 congressional mandate, is to reduce unnecessary imaging and the associated costs and radiation exposure, something that has wide conceptual support except perhaps from imaging vendors who may see demand for their products and services fall. While nominally only applicable to Medicare patients, this requirement is likely to see more widespread use because of the difficulties associated with segregating patients by payer.

It would be best if such guideline driven reductions in imaging use did not stop imaging that would have actually been helpful to the patient, but this may or may not ever be studied. Of course the CDS will not be free, so there are some front end and maintenance costs associated with obtaining and using the CDS, along with the personnel costs of monitoring and reporting. And there is the potential adverse effect on clinical productivity, as ordering physicians on one end and radiology practices on the other deal with actually using the software. We may remember here how much many physicians love their EHRs.

Also not necessarily free is the underlying AUC which may require licensing agreements from their creators. The American College of Radiology (ACR) has an interesting provision on their website in this regard which states in part that “the ACR allows individuals to use the ACR Appropriateness Criteria for research, scientific, and / or informational purposes only” but “If you wish to use the ACR Appropriateness Criteria for other reasons, please contact the ACR for permission and licensing information”. The warranty limitations are also interesting which includes that use is at your own risk. Software based on these or other criteria would presumably carry the CDS standard disclaimer of do not rely on this product, although no doubt in denser language.

While applying such standardized criteria (that have broad proof of appropriateness) to advanced imaging ordering may sound like a good idea in principle, it requires very careful execution in order to accomplish its goals without degrading other functions or having the only beneficiaries be the CDS vendors, the AUC copyright holders, and the extra personnel hired to make it all happen. Someday someone might study if the alleged benefits were actually realized while not doing any harm.

I am once again reminded of the issues faced by medical device manufacturers in doing things in compliance with the FDA’s Quality Systems Regulations which also were created with laudable goals, but never subjected to any measure of effectiveness. In this regard I once asked a highly placed FDA colleague “Do the Quality Systems Regulations result in quality systems that result in quality products?” In the spirit of my question he responded “That’s our position and we are sticking to it.”