JT Finnell, MD, MSc, FACEP, FACMI
Clinical Informatics Program Director
Indiana University School of Medicine
Our radiology department called a meeting to discuss a federal mandate to utilize Clinical Decision Support based on the American College of Radiology's Appropriate Use Criteria. Apparently, this is already live in the ambulatory world and is coming to EDs later this year.
The requirement is to choose a supported indication using computer assisted technology. I have heard EMR implementation of this requirement often fails, due to no logical choice being presented.
The whole thing sounds absurd. Has anybody else caught wind of this or implemented yet? What steps have you done to mitigate the negative impacts to your ED?
Utilization of “Appropriate Use Criteria (AUC) via Clinical Decision Support (CDS) for Advanced (defined as MRI, CT, NM & PET) Diagnostic Imaging Services” is a “newish” federal statutory requirement created by the “Protecting Access to Medicare Act of 2014” (PAMA) (see references below). Of note, implementation of this requirement has been delayed (originally scheduled for Jan 1, 2017) with an uncertain new date pending further definitions by CMS now due mid-summer.
Although the statute explicitly states “applicable setting” includes Emergency Departments, it further states exams for an individual with an emergency medical condition defined under the Emergency Medical Treatment and Active Labor Act (EMTALA) are exempt. This exemption is likely to only be relevant on appeal for payment denial. The EMTALA definition of EMC is a relatively high bar, often only determined retrospectively, and a substantial number of ED patients fail to meet this definition. Put another way, by the time you know a patient has an EMC, most tests will have long been ordered. So from a practical point, you may need to comply with this requirement regardless, except perhaps Level I trauma, cardiac arrest and other critical situations.
This legislation was part of the annual “SGR fix” in 2014, and in practice, these new requirements may seem onerous (or perhaps just one more “straw for the camel’s back”). But in this setting, you take the good with the “bad” (in quotes because many believe these sorts of “innovations” help make healthcare “better”). From a cynical point of view, it probably has more to do with money than care and will be expanded to all imaging eventually.
Barring some sort of reversal1, everyone will have to comply eventually. Further, this is merely part of a much larger effort to force standardization (reduce variability) in healthcare. Motives include patient safety, cost & fraud reduction via automated “black box” auditing, and efficiency. Untoward “cost” is the unaccounted overhead on providers to comply with mounting data input and compliance which may have the effect of offsetting these objectives (i.e. counterproductive).
1. President Trump signed an Executive Order on January 20th putting a stay on all new regulations. It is unknown if that will apply to this provision.
For more details, read on . . .
PAMA included a mandate that physicians utilize “appropriate use criteria” via “clinical decision support” for ordering advanced imaging studies such as diagnostic MRI, CT, and nuclear medicine (including PET). Plain X-ray, fluoroscopy, and ultrasound exams are not currently included. The appropriate use criteria requirements also only apply to outpatient settings such as physician offices, hospital outpatient departments (including EDs), ambulatory surgical centers, and any provider-led outpatient setting.
An additional provision has been defined in Rules (42 CFR 414.94) which describes “Provider-led entity” (PLE) which is “a national professional medical specialty society or other organization that is comprised primarily of providers or practitioners who, either within the organization or outside of the organization, predominantly provide direct patient care. Once a PLE is qualified the AUC that are developed or endorsed by the entity would be considered to be specified applicable AUC.”
What this means is a PLE (the American College of Radiology is one of a few current certified) can develop evidenced-based criteria which then become appropriate use criteria with regard to Medicare billing and reimbursement. I suppose this is preferable to CMS coming up with their own criteria that may or may not be based in reality.
Speculation: A stated indication has been required for diagnostic tests for a long time in order to get paid. If not included with the order, either the radiologist has to infer it or contact the provider. In more recent years, not just any indication would suffice, especially for high dollar tests. This legislation codifies this process and allows Medicare (and other insurers) to deny payment. This is largely done via “black-box” computer algorithms without human interpretation. You can see why the ACR might want to better define this process. So, as a PLE, the ACR came up with criteria to include definitions of 1) Appropriate care, 2) May Be Appropriate care, 3) Rarely Appropriate care [See: http://www.acc.org/about-acc/press-releases/2013/02/21/14/05/auc-methodology]
So, how do you “force” compliance from ordering providers to impact the downstream effect? Simple: define the appropriate indications for every test, and if the provider does not choose one of them, either refuse to order the test or require consultation. This is where “Clinical Decision Support” (CDS) helps. For each test, simply have a drop down list of “appropriate” indications. However, implementing this is not so simple as it requires accommodation by various EMRs. Ambulatory EMRs are ahead of this “game”. Hospital based EMRs are playing catch up. The downside being a pre-defined list does not always account for all scenarios and the “best” indication may not be present.
Just one more example of where hospital EMRs fail to meet the needs of patients and clinicians. Workaround (e.g. 3rd party software) solutions will be forth coming. In fact, the American College of Radiology (ACR) has created a solution for compliance.. See “ACR Select™“ [https://www.acr.org/Advocacy/eNews/Archive/2014/20140404-Issue/ACR-Select-Provides-Ordering-Physicians-with-Timely-Access-to-Imaging-Appropriateness-Criteria]
As with many such circumstances, this is largely being driven by payment.
Mitigation & Solutions
Protecting Access to Medicare Act of 2014” (PAMA)
SEC. 218. QUALITY INCENTIVES FOR COMPUTED TOMOGRAPHY DIAGNOSTIC IMAGING AND PROMOTING EVIDENCE-BASED CARE.
Language relate to setting & exceptions. For entire bill:
(q) RECOGNIZING APPROPRIATE USE CRITERIA FOR CERTAIN IMAGING SERVICES.—
(1) (D) APPLICABLE SETTING DEFINED.—In this subsection, the term ‘applicable setting’ means a physician’s office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, and any other provider-led outpatient setting determined appropriate by the Secretary.
(4)(C) EXCEPTIONS.—The provisions of subparagraphs (A) and (B) and paragraph (6)(A) shall not apply to the following:
(i) EMERGENCY SERVICES.—An applicable imaging service ordered for an individual with an emergency medical condition (as defined in section 1867(e)(1)).
PAMA Brief Summary
Section 218(b) of the Protecting Access to Medicare Act of 2014 amended Title XVIII of the Social Security Act to add section 1834(q) directing CMS to establish a program to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging services. In section 1834(q)(1)(B) of the Act, AUC are defined as criteria that are evidence-based (to the extent feasible) and assist professionals who order and furnish applicable imaging services to make the most appropriate treatment decisions for a specific clinical condition.
As previously implemented, SSA Section 1834(e)(1)(B) defines “advanced diagnostic imaging” procedures as diagnostic magnetic resonance imaging (MRI), computed tomography (CT), and nuclear medicine imaging procedures, such as positron emission tomography (PET). ADI procedures do not include x-ray, ultrasound, fluoroscopy procedures or diagnostic and screening mammography.
Case Study: Lessons Learned from Implementation of a Radiology Clinical Decision Support System [https://www.acr.org/Annual-Meeting/Program/Abstracts/2015/Informatics/045]
An Intro to Clinical Decision Support for Radiology [http://www.itnonline.com/article/intro-clinical-decision-support-radiology]