[FREQUENTLY ASKED QUESTIONS]

[FAQ s] [FREQUENTLY ASKED QUESTIONS]

Q1. What is a clinical data registry? A1: A clinical data registry is an organized system that collects uniform data (clinical and patient-reported) to evaluate specified outcomes for a population based on performance measures developed from Clinical Practice Guidelines. With the increasing usage of EHRs, registries have emerged as valuable solutions for harnessing the power of information technology to capture statistically relevant, evidence-based data to aid in decisions regarding the most optimal patient care. Such registries are already being successfully used within other medical specialties and medical associations, including the American College of Cardiology and the American Academy of Ophthalmology. Q2. Why is the AAO-HNSF providing this resource? A2: The AAO-HNSF is committed to continually improving and innovating otolaryngology-head and neck patient care. With the increasing adoption of EHRs and other advances in technology, physicians now have the ability to perform their own data analysis to inform better clinical decision-making. Using registries in this manner is the future of medicine, as evidenced by the success of the registries developed by the American College of Cardiology and the American Academy of Ophthalmology. The timing is right for otolaryngologists to be among the early adopters in strategically deploying information technology to drive quality improvement. Q3: Is Regent SM being developed as part of the Affordable Care Act or other government mandate? A3: Clinical data registries precede healthcare reform by two decades. They are not a mandated part of health care reform, nor are they required to comply with any federal regulations. The overarching purpose is to translate otolaryngology-head and neck surgeons clinical data that enables them to benchmark their practice's performance and drive improvement in patient outcomes. 1

Q4: How will AAO-HNSF develop Regent SM? A4: The AAO-HNSF is partnering in the development of Regent SM with FIGmd, Inc., a company that specializes in integrating EHRs with registries. FIGmd has developed and maintained registries for the American College of Cardiology and has completed integration projects for more than 70 major EHRs and is capable of working quickly with new EHR systems. Q5: How will Regent SM work? A5: Data relevant to the registry will be extracted automatically from the EHR and transmitted on a scheduled basis directly to Regent SM. Participating otolaryngologist-head and neck surgeons can then access the data and run queries on their own patient population to create practice patient registries and to benchmark practice performance and uncover potential areas for quality improvement. Results can also be compared to the larger aggregated data. Q6: How will Regent SM affect my practice workflow? A6: There will be no change to the practice workflow. Regent SM will be extracting data directly from the EHR. Q7: What will Regent SM provide for me? A7: Regent SM will offer the following benefits in a phased approach beginning with Public Quality Reporting capabilities: Public Quality Reporting Regent SM will help members report on quality measures for federal and private programs. 2

Demonstration of Value and Alternative Payment Models Regent SM will affirm effectiveness and quality of care provided; utilize data to more effectively negotiate with payers; and prepare for participation in alternative payment models. Quality Improvement and Clinical Effectiveness Regent SM will utilize longitudinal data to identify gaps in performance and gaps in care provided both at the individual practitioner and system levels. Maintenance of Certification and Licensure Regent SM will coordinate with and provide data to the American Board of Otolaryngology (ABOto) and state licensing boards to satisfy MOC and MOL requirements. Performance Measure Development Regent SM will allow more rapid and cost-effective development of performance e- measures to rapidly expand our portfolio through a measure authoring tool. This will allow the AAO-HNSF to author and simulate measures on registry data before launching the measures. Product Surveillance Regent SM will facilitate aftermarket research to document patient outcomes. Q8: Is it necessary to have an EHR system to participate in Regent SM? A8: EHRs are the preferred means by which to participate. However, web forms are also available. FIGmd also offers a solution, which will be part of Regent SM for PQRS reporting for paper-based practices. 3

Q9: Can Regent SM data be used for Physician Quality Reporting System (PQRS) reporting in the future? A9: AAO-HNSF is planning to submit Regent SM and related application materials to CMS to be approved as a Qualified Clinical Data Registry to report clinical quality data for PQRS in the future. Going forward, Regent SM will address quality reporting under MIPS as well. Q10: How can Regent SM inform me about my patient population? A10: You'll be able to monitor patient-level quality measures, track interventions, and evaluate outcomes at a population level. Regent SM allows users to run queries based on the demographics of otolaryngology patient populations in Regent SM. It can help you answer questions such as: What proportion of my patients has had Computerized Tomography (CT) for Acute Sinusitis? and What proportion of my patients has Pharmacologic Therapy for Persistent Asthma? Q11: How is population management via Regent SM different than via my EHR? A11: Regent SM is focused on specific measures and patient data only for those patients meeting the registry measures criteria. Therefore, the report run time is much quicker than that of an EHR, whose reporting functions are poorly developed, and often cumbersome to use. Q12: Who will have access to my data? A12: Regent SM collects, stores and reports data on an otolaryngologist-head and neck surgeon s behalf, taking every measure possible to safeguard it. The AAO-HNSF's technology partner, FIGmd, is compliant with all local and federal regulations governing these areas, including HIPAA provisions and the recently updated provisions as part of the American Recovery and Reinvestment Act/Health Information Technology for Economic and Clinical Health Act. 4

Q13: How will the AAO-HNSF use the data in Regent SM? A13: The AAO-HNSF is working towards developing performance measures that will accurately track both the otolaryngology patient population as well to support the depth and breadth of the specialty. Data will be used to formulate and test the measures developed. We will also be creating quality benchmarks so that you can compare your outcomes, and study whether or not quality improvement is necessary to improve quality across the specialty. We will also engage in research, identify gaps in care to fuel the development of additional measures and to support testing Clinical Practice Guidelines. Lastly, the data in Regent SM will be utilized to prepare for MIPS and Alternative Payment Models. Q14: Will data from Regent SM be used by any health plans to evaluate members performance? A14: No. Any reporting of your data or your measures will be under your control or with your permission. Q15: What are the costs for participating in Regent SM? A15: For the first 1,000 Members who enroll, the one-time application fee ($250) and the first year s maintenance fee ($295 annually) will be waived. Q16: What are the time commitments for my office staff? A16: The aim of Regent SM is ease of use. It is designed to require minimal effort from your staff. EHR integration typically requires one to two hours per week for three to four weeks from IT staff to assist in the installation and mapping process. Following installation, no additional work is required, unless the practice's EHR software is updated or changed which could require repeat of the installation and mapping process. 5

Q17: How do I get started? A17: Complete the basic registration form. Visit www.entnet.org/regent for more information and to sign up to be a pilot site. Q18: Do you have to be an AAO-HNS Member to participate in Regent SM? A18: Yes. Regent SM participation is open to U.S.-based practicing AAO-HNS Members. Q19: Is Regent SM available to other clinicians in my practice? A19: All U.S.-based practicing otolaryngologist-head and neck surgeons who are Members of AAO-HNS are eligible. Q20: Can academic medical practices participate in Regent SM? A20: Any U.S.-based practicing Member of the AAO-HNS, regardless of practice setting, can participate in Regent SM. Q21: Are all AAO-HNS Members in the U.S. expected to participate? A21: Participation in Regent SM is encouraged. Participation will help improve the quality of care provided by not only their individual practices but by the profession as a whole and it will facilitate broader discussions with regulators and private payers that will help the AAO-HNSF best represent your interests. 6

Q22: Do all physicians in a practice need to participate in Regent SM? A22: It is not required that all physicians participate, but participation by all physicians in the practice is strongly encouraged. Participation by all physicians in the practice will help generate data that most accurately reflects the entire practice s performance. Q23: When will Regent SM users receive their first report? What data will it include? A23: After full launch, and a few weeks after installation and data mapping, users will be able to receive their first report, which will include their performance rate on measures for each physician in practice and for each location. Q24: What can I expect in the first 6-12 months of the Regent SM pilot? A24: The first time measures are generated, it will be typical to have poor scores on most measures. This is often due to inconsistent data capture (not captured well, systematically, or put in the right place or right way), poor attribution (not clear which patients are in who s panel), lack of data capture (how lab results are reported), or lack of patient panel management processes (no mechanism to identify patients who haven t had immunizations, lab work, or a visit within prescribed time). This is not unusual but it often leads to better data capture, patient attribution and patient management. This is why the AAO-HNSF is investing time in pilot testing to assure that measures accurately reflect physician performance, that attribution is correct, and any gaps are identified and addressed before the full registry is launched. Q25: How can Regent SM be used for research? A25: The AAO-HNSF plans to use aggregate data in the future to facilitate research by members and for the testing of adherence to Clinical Practice Guidelines. 7

Q26: Will the AAO-HNSF create additional clinical data registry modules? A26: Once Regent SM is fully implemented, future registry modules will be explored. Q27: How will the focus of new registry modules be decided? A27: Registry topics will be determined by the leadership of the AAO-HNSF with input from the Registry Task Force. Q28: How do I submit suggestions related to the registry and recommendations for new topics? A28: Send an email to regent@entnet.org. Q29: Does Regent SM have any relationship to continuing medical education? A29: Regent SM may be utilized in the future for MOC, MOL, and as a means to identify performance gaps to support education that improves the quality of care. 8