What are appropriate use criteria (AUC) and why are we hearing about them now? According to the Centers for Medicare and Medicaid Services (CMS), AUC are “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.” ACEP has been working behind the scenes for the past two years in response to legislation which was passed in 2014. And yes, this is another burden that emergency physicians will have to shoulder beginning January 2018, when penalties (eg, Medicare payment denials) are scheduled to begin.
However, it may also have some benefit and help us care better for our patients.
The “Protecting Access to Medicare Act of 2014” (PAMA) included several provisions to slow the growth of Medicare costs, and one provision is AUC, where doctors ordering certain tests will be required to use clinical decision support (CDS) tools (eg, via embedded software in the electronic health record) for advanced imaging (defined as MRI, CT, nuclear medicine, and PET). Plain X-ray, fluoroscopy, and ultrasound exams are not currently included.
Practically, this law is part of a much larger effort to employ standardization (reduce variability) in clinical practice by targeting high use and/or high cost services. Three years after the regulations are implemented, physician “outliers” will be identified and notified that they are subject to preauthorization when ordering advanced imaging tests.
Is AUC applicable in the Emergency Department and What Steps Has ACEP Taken?
Yes, AUC will apply in the emergency department. Although PAMA explicitly includes the emergency department as a setting where AUC would apply, the law and enabling regulations state that if an individual has an emergency medical condition (EMC; as defined under EMTALA), the physician can forgo consulting the criteria. The key operative word is “has,” because it does not exempt patients who have not yet been determined to have an EMC.
ACEP protested this illogical interpretation: In order to determine that an EMC exists, certain tests, including advanced imaging, may be needed. As President of ACEP, Dr. Kaplan went to multiple meetings in Washington and Chicago to discuss this definition and what could be done to simply exempt the emergency department setting from this regulation. The argument was that EMTALA was in direct conflict with the interpretation of the PAMA law: EMTALA requires us “to use all measures to determine if a medical condition is an emergency medical condition as defined by EMTALA and as required by federal law” without any barriers to block that process; PAMA creates a barrier to doing so. A two-year series of comment letters and meetings with CMS officials ensued. We even went back to the bill’s author, Rep. Pitts, who wrote to CMS asking for a correction to what was a legislative drafting mistake. CMS did not make that change but did acknowledge our points. At the same time, they expressed concern about giving emergency physicians carte blanche to potentially “overuse” advanced imaging. The 2017 Medicare Physician Fee Schedule included revised language that provided more weight for clinical judgement by emergency physicians (see sidebar).
Dr. Kaplan, in an attempt to explore the potential pitfalls of implementation, even visited an emergency department which had been touted as a leader in AUC implementation at a national radiology meeting to see what they were doing. What he found was much more problematic than was advertised, especially in terms of ease of use. The emergency physician pioneers at that hospital had discovered many problems with implementation and were willing to share what they had learned, hopefully to help all emergency physicians as this process is regulated forward.
Given that the revised physician fee schedule language (see sidebar) doesn’t carry the full weight of codified regulatory language, this exemption is more likely to be helpful on appeal if payment is denied. According to clinical informaticist and EMTALA expert Todd B. Taylor, MD, “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. In other words, by the time you know a patient has an EMC, most tests will have long been ordered. So, from a practical standpoint, emergency physicians may need to comply with this requirement, except perhaps for Level I trauma, cardiac arrest, and other critical situations.”
When Will AUC Be Required?
Start-up was originally scheduled for Jan. 1, 2017. Since the regulation affects physicians, the annual physician fee schedule was the vehicle chosen by CMS for AUC’s implementing rules. The 2017 final rule pushed the start date back a year to Jan. 1, 2018. Given the continuing problems with integrating AUC into hospital electronic health records, many physician groups, including ACEP and the American Medical Association, are advocating additional delays.
If CMS agrees, any change to the startup date would be included in the 2018 physician fee schedule, which will be finalized by Nov. 1, 2017. Barring some sort of intervention by Congress or a hold authorized by the president, every physician will have to comply eventually.
Who Designs Appropriate Use Criteria?
Another provision in the regulation (42 CFR 414.94) describes a “provider-led entity” (PLE) which is “a national professional medical specialty society or other organization that is comprised primarily of providers or practitioners who…predominantly provide direct patient care. Once a PLE is qualified by CMS, the AUC that are developed or endorsed by the entity would be considered to be applicable AUC.”
Once certified, these entities (The American College of Radiology and Brigham and Women’s Physician group are two of 11 currently certified) develop evidenced-based criteria which can then be used for Medicare billing and payment purposes.
Most emergency physicians know that they need to document an indication for certain diagnostic tests for payment purposes. If not included with the order, either the radiologist has to infer it or contact the provider. In more recent years, the bar has been raised, especially for high dollar tests. PAMA codifies this process and allows Medicare (and other insurers) to deny payment. This is largely done via “black-box” computer algorithms without human interpretation. It’s easy to see why the American College of Radiology (ACR) jumped in to better define this process. So, as a provider-led entity, ACR came up with criteria to include definitions of 1) appropriate care, 2) may be appropriate care, 3) rarely appropriate care.
How Will AUC Consultation be Enforced?
Provider-led entities define the appropriate indications for every test, and if the ordering physician does not choose one of those indications, the software program will either refuse to order the test or require consultation. This is where CDS may help. For each test, there is a drop-down list of “appropriate” indications. However, implementing this is not so easy and may require accommodation by certain electronic medical records (EMRs). Ambulatory EMRs are ahead of this game while hospital-based EMRs are playing catch up.
In addition, the downside of using a predefined list, especially one developed by another specialty, is that it does not account for all scenarios and the “best” indication may not be present. ACEP has been working with the major vendors of the AUC’s to ensure that earlier frustrations with the lack of specific emergency medicine indications and parsing them into a separate and easily viewed list have been addressed. There is much more work to be done.
This is just one more example of where hospital EMRs fail to meet the needs of patients and clinicians. Workaround (eg, third-party software) solutions will be forth coming. In fact, ACR has created a solution for compliance—see “ACR Select.”
Potential Benefits of AUC
- The use of the CDS may provide information regarding utilization and, if evidence-based emergency medicine guidelines are used, it may aid the decision-making process.
- Five of ACEP’s 10 Choosing Wisely recommendations involve advanced imaging studies, and documenting more consistent practice and decreased cost may provide leverage regarding the need for other resources.
- Documenting consistent practice should allow us to demonstrate the value emergency medicine brings to patients and the quality sphere.
- When the outside primary care physician or specialist sends a patient to us for an advanced imaging study, the CDS may offer support for not having such tests performed in the emergency department.
Ongoing Concerns and Efforts
- This requirement currently applies to advanced diagnostic imaging services defined as MRI, CT, nuclear medicine, and PET). ACEP should not support expansion to other studies.
- This requirement has been delayed until at least January 2018, and should be further delayed due to a lack of widespread availability of suitable technology.
- While it may apply to the emergency department as a hospital “outpatient” department, EMCs are specifically excluded, and for good reason. Before implementing, hospitals must address the additional administrative overhead and the general lack of functional tools available within the EMR to make the use of CDS safe and effective for this purpose.
- One can argue the EMC exclusion, along with the types of studies to which this requirement applies, functionally eliminates this requirement for emergency departments. In the ED context, advanced diagnostic imaging services are never ordered on patient without a potentially serious medical condition (ie, EMTALA defined EMC). This is very different than other outpatient settings where routine non-emergency advanced diagnostic imaging services are most frequently ordered.
- There is no indication that the “black box” edits will do anything more than correlate the test ordered with an approved indication. Functionally, this means the ordering physician could choose any approved indication, whether or not it has a bearing on the actual reason for ordering the test. Whether the future will bring further scrutiny (eg, additional correlation with the test result or final diagnosis) remains to be seen.
- If this requirement is to be applied to the emergency department, only a well-designed functional established CDS that is integrated into the typical workflow (eg, integrated into the EMR) should be employed.
Many thanks to Todd Taylor, MD, FACEP, and J.T. Finnell, MD, FACEP for allowing us to use material from their article for ACEP’s Informatics Section Newsletter, March 2017.
Dr. Kaplan is immediate Past President of ACEP. Ms. Tomar is federal affairs director for ACEP.
What Should You Be Doing Now?
By Todd B. Taylor, MD, FACEP
By June 30, 2017, CMS will release a list of qualified CDS mechanism (CDSM) solutions. This list may or may not include specific EMR employed solutions. Depending on your current EMR, workarounds may be necessary. Nevertheless, most EMR vendors are already focused on this requirement.
- Determine if your hospital already has a plan for adoption of a CDSM. If not, make them aware and take initiative in managing the impact on the emergency department. These efforts may also be driven by radiology as penalties apply to radiologist reimbursement as well as the hospital.
- Insist on being involved in the development and review of the CDSM adoption plan. This plan may be quite detailed, but here are a few elements you should note:
- Perform an “environmental assessment” (ie, what you currently have, what may be barriers to adoption, who are the stakeholders, etc.).
- Define the scope of the project to include time lines, functionality review, safety assessment, impact on workflow, implementation schedule, training, etc.
- Explore solutions (eg, are they available within your current EMR or will you require a qualified third party CDSM?). This evaluation must include a functional suitability assessment. For example, if the CDMS integrated within your EMR is not suitable for the emergency department, it may require adoption of a third-party solution. Remember, most solutions are designed with a “traditional” outpatient focus and NOT for an ED environment.
- Review the implementation plan. Note: Most IT projects fail not because of the technology (ie, the software), but rather due to poor implementation. With many IT projects, there have been reasonable successes and unmitigated disasters with exactly the same product.
- The CDSM must be CMS qualified.
- ED physician leadership must be included in the process of evaluation, selection implementation, and ongoing assessment. (See ACEP Policy: Health Information Technology.)
- The plan must address the additional administrative overhead related to this requirement and how it will be mitigated by the chosen CDSM solution. This may result in a determination that the current EMR lacks functional tools and a third-party solution is required.
- The CDSM solution must accommodate the unique needs of the emergency department versus merely forcing a routine outpatient system onto the emergency department.
- The solution must be safe and effective. It may be difficult to imagine how this could impact patient safety, but if inordinate delays result then that may be the result. Whether this particular CDSM effort is “effective” remains to be seen. Evidence from other initiatives such a provider order entry have been mixed for both safety and effectiveness.
- The emergency physician leadership should advise administration that they will make every effort to comply with the CDSM system as designed, but cannot be held responsible for situations in which no logical “approved” indication exists based on the patient’s clinical findings. In such circumstances, the closest alternative approved indication will be selected. It may be prudent to flag such instances to provide feedback to the vendor and provider-led entity.
Dr. Taylor is clinical informaticist and EMTALA expert, and is board certified in emergency medicine and clinical informatics.