CMS and Clinical Decision Support
William A. Hyman
Professor Emeritus, Biomedical Engineering
Texas A&M University, w-hyman@tamu.edu
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Recently I commented here on House bill HR 3303, the Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013. That legislation seeks to amend the Food, Drug and Cosmetic Act by formally defining medical software, and then removing “clinical software” (including Computer Decision Support (CDS)) and “health software” from FDA regulation. HR3303 is currently in committee.
CDS has been addressed again in HR 3705, the “Excellence in Diagnostic Imaging Utilization Act” which, among other things, would require the use of an approved CDS in deciding whether or not to order advanced diagnostic imaging in the outpatient setting. While I tend to think of CDS and imaging in the context of the use of CDS to interpret or “read” the image and make diagnostic determinations or suggestions, here the would-be required CDS is for deciding whether to obtain the imaging in the first place. Compliance with this provision would be a prerequisite for federal reimbursement. Two factors which are not explicitly stated may be in play here. One is the control of the cost of what may be judged to be unnecessary advanced (i.e. expensive) imaging. The other could be to protect patients from unnecessary radiation. For those that fear the canard of “death panels”, this bill clearly states that the practitioner is not bound to follow the advice received from the CDS, but only to have consulted it. The required CDS may be embedded in an EHR, but a separate web portal is also permitted.
There is also a registry requirement that requires patient specific identification to be entered thus in turn raising HIPAA privacy issues with respect to the movement and storage pf patient data. Evidence of registry submission would be part of the requirement for reimbursement. The registries, to be established and maintained by medical specialty societies, must also enable unspecified future research.
As with all CDSs’, a key question here is what is the basis for the advice to be provided? In this case the bill uses explicit language that requires the CDS to use only standards and guidelines developed by national medical specialty societies, and to have permission from the relevant society to use their material. In some cases such guidelines from different societies might conflict with each other, illustrating the observation that standards are wonderful, that is why we have so many of them. To partially address this the CDS must indicate which standard is being followed, but reference to more than one standard or resolving any discrepancy is not required.
While the basis for the CDS is thus established, there is no specific language as to how it would be determined whether or not the CDS is in all situations accurate in getting the answer that the standard or guideline dictates, i.e. is the CDS programmed correctly? Notably in this regard, the bill is silent on whether such a CDS is subject to FDA regulation as a medical device.
The CDS must also be “regularly and timely updated.” This addresses the generic concern that the advice provided by a CDS might have been appropriate at the time it was developed, but at some later time the standards and/or the underlying science may have changed. Besides calling for such updating, the bill does not specify how the updating would work, or what is timely.
As with most bills, it remains to be seen if HR 3705 progresses toward becoming law. One private congress watching web site (www.govtrack.us) gives its prognosis as 2% for getting past the committee, and 0% of being enacted.