Anyone you ask for their opinion on what they consider to be the key trends shaping the future of healthcare today, is likely to mention evidence-based medicine as one of the top trends – alongside other ‘hot topics’ such as personalized medicine and multi-disciplinary care delivery models. These trends have implications on every segment of the healthcare industry, from life sciences to medical devices. While this year’s European Congress of Radiology (ECR) will likely not be remembered for the unveiling of clinical and technological breakthroughs in imaging equipment or imaging pharmaceuticals, the 2015 ECR brought some very interesting developments with regard to the delivery of evidence-based clinical decision support (CDS) to medical imaging in Europe, through the debut of the ESR iGuide referral guidelines.
The application of evidence-based medicine (EBM) concepts to various areas of clinical care can come in many shapes and forms, of which electronic clinical decision support (CDS) solutions perhaps constitute the most solid model for the future. When made accessible at the point of ordering, such as by primary care physicians using electronic medical record (EMR) systems, CDS systems can assist physicians in making the right choice of test or drug for their patient. This support function is achieved by exposing the different next-step alternatives, rating the appropriateness of each one, and highlighting the most recommended one based on existing findings from thousands of peer-reviewed papers, clinical studies, best-practice guidelines and clinical protocols.
When it comes to prescribing medications and drug treatments to patients, it is already commonplace in most advanced economies worldwide to rely on computerized physician order entry (CPOE) or e-Prescribing systems, rather than on traditional paper-based prescriptions. It is also conventional for prescribers to check for the validity of the order (e.g. potential allergies), and its viability (e.g. the outcomes one can expect based on available clinical studies).
However, when it comes to ordering imaging examinations to patients, physicians still have to rely mainly on their own knowledge of imaging, and their past experience on what imaging can do for their patients. The Imaging world is therefore way behind the Pharma world today in its ability to leverage evidence-based guidelines for appropriate ordering of imaging exams. As such, there is probably a considerable opportunity for collaboration, knowledge and cross-pollination between the two fields in the eCDS area.
While there might be greater convergence with Life Sciences IT in the future, , radiology and imaging continue to demand their own, tailored informatics solutions, much like has been the case in the past with radiology information systems and picture archiving and communication systems (RIS, PACS). A similar, somewhat silo’ed evolution seems to be taking place with the application of CDS systems to medical imaging, as they seem to be evolving along their own technology track and as part of a separate industry effort. The same applies from a regulatory standpoint, as there has been distinct legislation pertaining specifically to advanced imaging. Similarly from a practice standpoint, as exemplified by the prior authorization mechanisms specific to advanced imaging that are being carried out by radiology benefit management (RBM) firms in conjunction with private payors in the U.S.
Currently in the U.S. – the world’s largest user of and spender on medical imaging services – two core incentives underlie the ongoing push for replacing prior authorization models with electronic CDS. The first one is the need to better manage the utilization of expensive medical imaging procedures, with the end-goal of being able to curtail the growth in total expenditures by other means than the ‘brute-force’ approach of slashing reimbursement rates. The most recently published procedure volume and spending data indicate that the reimbursement cutting approach - which has been relied on heavily over the last several years - seems to have attained some of its goals, but not without bringing to the discipline a strong feeling of discomfort and a sense of unsustainability. The second objective is being able to ensure the appropriateness of imaging orders, essentially ensuring each patient is administered the right exam, while avoiding unnecessary exams and the overuse of imaging, especially high-cost imaging and ionizing imaging. While they are commendable in principle, utilization management and imaging appropriateness come at a price: Both of these measures are likely to imply a reduction in the number of advanced imaging procedures and in the spending on imaging, and possibly of radiologist revenue as well. The upside, however, is they both ultimately help maximize the perceived value of imaging as a whole by putting the discipline in better alignment with the emerging value-based healthcare environment.
There is wide consensus within the global radiologist community that the appropriate use criteria (AUC) developed by the American College of Radiology (ACR), which bare the name ACRSelect, are indeed the world’s most extensive, best-structured and best-documented set of AUC for radiology imaging. The European society of Radiology (ESR) showed it recognized this fact, when the decision was made to adopt ACRSelect as the basis for AUC in Europe through the launch of the ESR iGuide at the 2015 ECR.
The fruit of collaboration between the ACR and the ESR, the launch of iGuide is also the result of a partnership with the National Decision Support Company (NDSC), the private company that holds exclusive licensing rights for the commercialization of ACRSelect, and which has been delivering ACRSelect to the U.S market throughout the last three years. But the official launch of iGuide does not mean the technology is just making its entry into Europe. In fact over the last two years, following on the success of University of Barcelona, about ten additional pilot projects have already been launched in various other European countries, including in the United Kingdom, Germany, Italy, Spain, Portugal, and Sweden.
Led by Lluis Donoso, incoming President of the ESR, the first pilot project using ACRSelect in Europe was implemented at the Hospital Clínic of Barcelona starting in the end of 2013, involving mainly General Practitioners. Less than two years later today, after a trial period which involved Spanish translation, IT integration, staff training and most importantly change management, the pilot project has been recognized as a sound success. As such, moving forward the use of the upgraded ordering system will soon no longer be optional, but mandatory.
It is fair to say that the launch of ESR iGuide is a decisive first step towards harmonizing AUC for imaging at a global level. Similar interest in Oceania or other parts of Asia suggests that the radiology field is indeed headed towards a globalization of ordering guidelines. That said, the visionaries in the field all concur that a localization effort is critical in leveraging AUC across different parts of the world. The initial, generic guidelines must first be localized at the regional or national level, and then potentially at the local or community level as well.
‘Localizing’ AUC includes, but is not limited to supporting local language. A certain country might decide to modify certain guidelines based on the cost of a particular procedure, the availability of a certain type of equipment, the human expertise available, the medical culture in a given environment, or any existing local policy such as radiation dose reduction programs or similar patient safety measures. For example, the U.S. being a notoriously heavy user of nuclear imaging, the technology being widely mastered and accessible throughout the country, it is inclined to giving higher AUC ratings to nuclear imaging than Europe.
In her talk at the ECR 2015, Dr Erika Denton, who is National Clinical Director for Diagnostics with NHS England, shared some interesting figures regarding the extent of the ‘localization’ effort that the ESR underwent in “Europeanizing” the ACR’s ACRSelect AUC into the ESR iGuide AUC: 16% rating changes – that is, changes in the ratings attributed to an orderable imaging exam; 9 % category changes – that is, changes in the imaging modality being recommended in a given clinical scenario.
As a database of AUC that is agnostic to any particular information system, ACRSelect and ESR’s iGuide constitute the potential content of a CDS system for imaging. As such, they represent only the content part, and not the delivery mechanism for this content. The delivery aspect is equally essential to the effective use of AUC, since it is the way to ensure this use is adequately integrated as part of the clinical workflow, and that it properly closes the loop on the imaging order. That is, by furthering the communication and collaboration mainly between the physicians ordering the imaging exam and the radiologists fulfilling the orders, but also involving other stakeholders vested in quality efforts and outcomes analyses.
In this context, the role of industry players is essential. Notably, NDSC, which has been driving partnerships with several EMR and RIS vendors; Nuance Healthcare, the market leader in radiology reporting and speech recognition, which, in recent moves, has been driving CDS for the radiologist at the time of interpretation; and with others industry actors, such as M*Modal – Nuance’s closest competitor – as well as EMR giants such Epic and Cerner, likely following suit soon.
SIDEBOX: Five Determining Years Lie Ahead for Imaging CDS in the U.S.
The last few months have seen some very important legislative changes in the U.S. pertaining to the ordering of advanced diagnostic imaging services. The Health and Human Services (HHS), which administers the Centers for Medicare and Medicaid Services (CMS) - the single-largest payor for imaging services in the country and possibly in the world – has firmed up the timeline and fast-tracked the issue for the next five years:
- The Protecting Access to Medicare Act (PAMA) of 2014 mandates that professionals ordering advanced diagnostic imaging services certify that they have consulted the appropriate use criteria (AUC) applicable to the imaging modality beforehand.
- In mid-November of 2014, HHS will specify which AUC are to be relied upon for advanced imaging services.
- On April 1, 2016, HHS will publish a list of approved appropriate use mechanisms.
- Starting January 1, 2017, provider reimbursement will be conditional on the inclusion of information about the qualified CDS mechanism that was used for the procedure.
- By January 1, 2020, HHS will establish a process for identifying outlier ordering professionals and require prior authorization for services ordered by outliers.