This article is more than 5 years old. Information may no longer be current.
IRIS Registry to allow wide-ranging access to accurate ophthalmology data
This spring, the American Academy of Ophthalmology is scheduled to launch the Intelligent Research in Sight Registry, a secure data repository intended to help ophthalmologists share vital clinical data.
While the concept of a clinical registry is not new to ophthalmology, the Intelligent Research in Sight (IRIS) Registry will be the specialty’s first truly national database. The registry is designed to allow clinicians and researchers to seamlessly collect data and use them to improve patient care, comply with government quality reporting requirements and, ultimately, conduct clinical and postmarket research.
The AAO announced the registry’s launch at its annual meeting in November 2013.
There is great potential for the IRIS Registry to be used in clinical research, according to Michael F. Chiang, MD.
Image: Petricek G
Clinical measurement is an essential tool for improving care, according to William L. Rich III, MD, AAO medical director of health policy and chair of the Registry Measure Development Workgroup.
“It’s a basic premise that in order to improve anything, you have to measure it,” Rich said.
Primarily, the registry will help ophthalmologists improve the quality of care, Michael X. Repka, MD, MBA, AAO medical director for governmental affairs, said.
Michael X. Repka
“The IRIS Registry formalizes the whole concept of performance improvement in an office setting,” Repka said. “The ability to describe how you’re doing compared to a peer group has certainly been robust in its ability to change practice in many industries, so I would expect it to do the same thing in ophthalmology.”
The registry will eventually allow researchers to use electronic health records (EHRs) for clinical research, an attractive prospect, according to Michael F. Chiang, MD, chair of the AAO’s Medical Information Technology Committee.
“One of the benefits of these electronic records is that data can be multipurposed for different uses and can be combined among different institutions,” Chiang said. “That’s exactly what our vision is for the IRIS Registry, that by developing this national registry of ophthalmic data, we can collect data that are relevant to ophthalmology and all of the key diseases for different ophthalmic subspecialties and then pool that data in a central repository.”
The registry interfaces with most major EHR systems.
Laurie K. Brown, COMT, COE, OSA, OCS, practice administrator for Drs. Fine, Hoffman & Sims LLC, discussed the seamless transmission of data from the practice’s EHR system to the IRIS Registry.
Laurie K. Brown
“The IRIS Registry should help us by pulling data from our EHR and allowing us to report it without having to do separate data entry,” Brown said. “Some of our societies have already offered registry affiliations we could use, but it meant an extra expense and entering data. We would like to maintain our efficiency and meet reporting requirements.”
Clinical registries will change the way care is delivered across medicine, according to David May, MD, PhD, chairman of the board of governors of the American College of Cardiology and immediate past president of the Texas chapter of the American College of Cardiology. The IRIS Registry is partly modeled on a registry launched by the American College of Cardiology.
“I have a very strong belief that the registries will dramatically improve care,” May said. “The clinical registry strategy is going to revolutionize the way that we provide care, not just in the U.S., but around the world.”
Preparation and piloting
The IRIS Registry is being piloted in 35 states among 140 eye care practices with 916 providers handling 2.68 million patient encounters. The AAO expects the registry to include 2,020 physicians and 15 million to 20 million patients by 2016, according to an AAO news release.
The Centers for Medicare and Medicaid Services is expected to designate the IRIS Registry as a qualified data registry later this year, Rich said.
“Later this year, we will meet all of the criteria for a qualified data registry,” he said. “We’re still working with CMS to make it more robust and more attractive to physicians.”
William L. Rich III
In the late 1990s, the AAO launched a registry called the National Eye Outcomes Network, Rich said.
“It failed, even though we had great data, because No. 1, it was really disruptive to a patient practice. I was a beta site. In my group, my technicians and staff begged me to get out of it. It totally disrupted the office, and nobody wanted the data,” he said.
New technology and reporting requirements make the formation of a registry today both feasible and necessary, Rich said.
“We’re in a different era now where people are insisting on improvement in quality. So, our ability to formulate a registry, to look at the natural course of disease and our interventions in it, is really good timing,” he said. “And now, unlike the 1990s, we have technology that enables us to do this in a risk-adjusted way and without interrupting our busy practices.”
Registry data will be anonymous.
“The Academy [controls] the benchmark data and nobody has access to that,” Rich said. “You, as the surgeon, the physician, have access to the identification of your patients and your own outcomes, so you have a chance to improve. And you alone determine what happens to your data.”
At Brown’s workplace, the plan is to participate in the IRIS Registry using the Centricity EMR, one of many systems mapped to the registry. IRIS Registry proprietary software allows practices to transfer data automatically from their EHRs to a registry.
The IRIS Registry is also mapped to Compulink, Drs Enterprise, eClinical-Works, Eyefinity, ExamWRITER, Eye-MD EMR, GE Centricity EMR, IO Practiceware, iMedicWare, MaximEye EHR, MDIntelleSys MDoffice, Medflow, NexTech, NextGen, Vitera Intergy EHR and WebChart EHR.
Research and surveillance
There is great potential for the IRIS Registry to be used in clinical research, Chiang said.
“Using the registry as infrastructure for research is in the future,” he said, “but that’s not what it’s being used for right now.”
The use of paper charts to perform statistical analysis is cumbersome, time-consuming and prone to errors. Use of the IRIS Registry to collect and analyze clinical data will rely heavily on the standardization of clinical terminology and outcome metrics, Chiang said.
“Things were never really stored consistently in a lot of these records. What we’re doing with IRIS is going to take a lot of effort to develop standardized quality measures and data elements so that we’re getting the same data from everybody who is participating in the registry,” he said. “In that sense, we’re really moving from one doctor/one institution to looking at ophthalmic data on a large scale. This has never been possible in the history of medicine or ophthalmology before.”
The registry will enable researchers to collect and analyze data for longitudinal and cohort studies involving various surgical procedures.
“You could also collect data from a set of patients who have a certain set of characteristics and follow how they do over time,” Chiang said.
The registry will also help clinicians and regulators perform postmarket surveillance of ophthalmic drugs and devices.
Currently, given the amount of data and the slow pace of analysis, researchers often do not pinpoint risk factors associated with adverse events, Chiang said.
“[It can take] years or even decades to discover those associations because there’s often no infrastructure to collect the data and study it in that way,” he said. “When people aren’t looking for those associations and when there’s no way to really pool those data, it is sometimes a little bit hit-and-miss for what individual doctors or scientists notice in terms of ‘this drug is associated with this long-term side effect,’ especially if there’s no way to pool those data locally or nationally.”
The IRIS Registry will reduce the cost of large clinical trials by facilitating the choice of appropriate patients, May said.
“We could avoid a $50 million trial to answer a question and reduce that to a tenth of its cost,” he said. “That would be an enormous step forward. We certainly are moving in that direction.”
The registry will also enable clinicians to use real outcomes, not arbitrary endpoints, in clinical trials.
“We in medicine often use surrogate endpoints rather than patient outcomes,” May said. “Outcomes data are what the registry does best. It lets us see that. It lets us measure good and bad outcomes, improvement that occurs in this fashion and areas where improvement does not occur.”
Quality reporting tool
Overall, the IRIS Registry will help practices decipher and comply with complex regulatory guidelines, Rich said.
The registry will facilitate reporting on 2014 Clinical Quality Measures (CQMs) for the Medicare EHR Incentive Program (meaningful use) so that practices can qualify for bonuses and avoid penalties. Beginning this year, all providers reporting on stage 1 or stage 2 meaningful use criteria must report on CQMs specified in the stage 2 rule issued by CMS.
The registry will also enable practices to participate in the Physician Quality Reporting System (PQRS), which involves incentive payments and payment adjustments to promote the reporting of quality measures.
Practices may earn a PQRS incentive by reporting quality measures data to a participating registry, according to a CMS document.
“The PQRS is sort of the hub of everything. It seems to be the backbone of CMS’ plans for gathering data and then modifying the way that doctors are paid in the future,” Brown said. “PQRS reporting is part of the meaningful use reporting, and it is part of what you need to do at a lower level to mitigate penalties for not reporting. It is going to affect your reimbursement. The incentives are going away, but the penalties will remain.”
Participants in the PQRS must report on nine quality measures for 2014, Rich said.
“Ophthalmology has done very well in all these value-based programs. We’re always in the top three due to great communication and education of physicians,” he said. “But the ability of my group of 11 doctors to report successfully on nine measures, it just can’t be done. There’s no way you can manage nine measures, and to avoid penalties, you have to get 50% on three measures. The registry will enable you to do that.”
The registry will help practices report the additional measures efficiently, Brown said.
“It should help us meet PQRS requirements, which are becoming increasingly onerous,” she said.
Brown said her practice was previously meeting three measures in a claims-based way, but reporting on nine measures in that fashion would be untenable.
“We’re looking for the most efficient way to report those measures, and a registry or direct EHR reporting are better options,” she said.
Currently, ophthalmologists have a 57% success rate in quality reporting. With the IRIS Registry, the success rate is expected to be about 94%, Rich said.
“Right now, it’s hard to find measures for the traditional claims-based PQRS participation,” Repka said. “So, if there’s a way to facilitate it by participating in these kinds of products, it would make it much more feasible to be successful.”
Furthermore, registry models help measure process improvement and stimulate research, Repka said.
Some specialties do not have PQRS measures, and the registry will enable ophthalmic subspecialists to design their own, Rich said.
“If you participate in a qualified clinical data registry, you don’t have to have PQRS measures. You can create your own measures. We are going to be able to develop quality metrics for everybody. Everybody can improve, and everybody will benefit,” Rich said.
The registry will also help practices report measures using the value-based modifier, a new feature of PQRS. In 2015, physicians in groups of 100 or more who submit Medicare claims under a single tax identification number will be subject to the value-based modifier, based on performance in 2013.
“The value-based modifier is how, essentially, they’re going to evaluate physicians and pay them. Everyone will have this modifier applied to them by 2017, from what I understand,” Brown said.
Groups will be required to choose one of three pathways for PQRS group reporting: Web interface, registry, or request that CMS calculate group performance on quality measures from administrative claims, to avoid a negative 1% value modifier adjustment to the 2015 payment under the Medicare Physician Payment Schedule.
“For a practice, that’s pretty scary,” Brown said. “Regarding the PQRS measures from which we had to choose, not all of them make a whole lot of sense and not all of them really reflect enhanced care. … It all needs to make sense.”
The registry will likely help practices save money as the Medicare payment structure shifts to a value-based model, providing the appropriate treatment and avoiding unnecessary care, Repka said.
“Not only is there value to the patient’s improved quality of care, there’s value to the taxpayer for better care, hopefully at lower cost, and its success for the physician as well,” Repka said, adding that physicians can then participate in the payment system as it moves to value-based measures rather than volume-based measures.
A template for success
Participation is nearly 100% in the NCDR CathPCI registry, one of the American College of Cardiology inpatient registry, according to May.
“Participation has been outstanding. We have unbelievable levels of participation from our hospitals, over 1,500 across the country, in our major registries, which are invasive cardiology registries,” he said. “We also have over 1,000 folks involved in PINNACLE, our outpatient registry.”
Registries help clinicians identify areas in which care is deficient, May said.
“The ability to make improvement in the quality of care is measured literally in months because the volume of information that doctors get back allows them to take very quick corrective action,” he said. “The ability of a practice, physician or location to parse the data by those different metrics allows you to very quickly recognize an area of deficiency, address it and immediately make corrections. So, in that regard, the registries have been tremendously helpful in helping us improve the quality of care, certainly in cardiology.”
The IRIS Registry will help clinicians to longitudinally track outcomes from specific procedures, May said.
“I think the IRIS Registry … is going to be outstanding because you are able to envision a linkage between the procedure done in a surgery center … and then the follow-up that takes place, which is that next generation of registry sophistication,” May said. “You can envision a whole variety of very straightforward observations that you might make — this particular approach, this particular anesthetic, this particular type of implant had a better or worse outcome in these particular types of patients — which I think will be enormously beneficial.”
Registries will be used to coordinate care across medical specialties in the future, May said. – by Matt Hasson
References:
For more information:
Do you foresee incorporating the IRIS Registry as a boon or a burden with regard to benefiting your practice?
Data should be handled with utmost care
I applaud the AAO for undertaking the daunting task of creating the world’s first ophthalmic patient registry. If any organization will manage well the complexities of creating and housing such a database, it will be our own association. But I worry seriously about the care with which such data must be approached. Beyond safeguarding the privacy of patient information is concern for how the data are interpreted and what actionable conclusions about physicians’ performance are drawn.
John A. Hovanesian
Take, for example, the highly experienced and skilled cataract surgeon who receives referrals for the toughest cases of intraoperative floppy iris syndrome, pseudoexfoliation and uveitic cataract. Complication rates in this surgeon’s preselected population of patients would certainly be higher than in the general population, regardless of the surgeon’s abilities. Yet data alone would suggest deficiencies in this surgeon’s outcomes.
And what about the physician whose patient population is older or poorer, with more prevalent and more morbid pathology? Would not his increased use of diagnostic tests and therapeutic procedures suggest that he is “milking” the system for financial gain? (Read The New York Times recent series of articles on physicians’ roles in the high cost of medicine to see how the media, and consequently the public, consider doctors guilty of profiteering until proven innocent.)
One thing is for sure: Collecting data on the outcomes of our care will only increase in the years ahead. What is most important is that those interpreting the data are guided by reason and insight rather than preconceived notions.
John A. Hovanesian, MD, FACS, is OSN Cataract Surgery Section Editor. Disclosure: Hovanesian has no relevant financial disclosures.
Registry a boon to outcomes, compliance
The IRIS Registry will be a boon for participating ophthalmologists, both in the immediate future and in the long term.
Flora Lum
In the short term, the IRIS Registry will streamline the time spent on meeting changing regulatory requirements and take over some of the burden in keeping up with these changes. For those utilizing an EHR 2014 certified technology to be used in the Medicare EHR incentive programs for the entire year, submission of clinical quality measures data through the IRIS Registry also satisfies the requirement to report for PQRS, as well as the stage 2 meaningful use menu measures to report to a specialized registry. For those without a 2014 certified EHR technology for the entire year, the IRIS Registry is available to report on the cataract measures group (20 patients) or nine individual measures. For practices of 10 or more eligible professionals, performance in PQRS in 2014 is important to avoid a penalty in 2016 with the value-based modifier program.
In the long term, the IRIS Registry will help improve patient outcomes. Ophthalmologists can use the IRIS Registry data to monitor patient outcomes, track procedures, identify and address gaps in quality of care, as well as manage clinical conditions for entire patient populations. Unlike many clinical registries that include laborious data entry, confusing technology and little immediate return on effort, the IRIS Registry is designed to require minimal input and data entry from staff and to be user-friendly, timely and responsive to the needs of the profession.
Flora Lum, MD, is policy director, quality of care and knowledge base development, for the American Academy of Ophthalmology. Disclosure: Lum has no relevant financial disclosures.