IRIS A Qualified Clinical Data Registry

1. IRIS A Qualified Clinical Data Registry Consumer-Purchaser Alliance September 9, 2014

2. William L. Rich III, MD, FACS Medical Director for Health Policy American Academy of Ophthalmology

3. Dr. Rich has no financial conflicts

4. Introduction to the IRIS™ Registry • IRIS™ Registry (Intelligent Research In Sight), the nation’s first comprehensive, longitudinal eye disease clinical registry: • Enables ophthalmologists across the country to use clinical data to improve care delivery and patient outcomes. • Uses scientifically valid and HIPAA-compliant methods to collect data from patient records – directly from certified electronic health record systems using a systems integrator. • Helps ophthalmology practices meet the requirements of the federal Physician Quality Reporting System, streamlining the way to quality-based payment bonuses.

5. QCDR:Qualified Clinical Data Registry • Part of the “fiscal cliff” legislation of 2012 • “A PQRS reporting mechanism” • For 2014 PQRS must report on nine measures across three domains, and one outcome measure • For 2015 proposal to publicly report on three outcome measures or two outcome and one resource use measure.

6. Advantages of QCDR • Allowed to report on up to 30 “native”, non NQF measures. • Enables specialties to CREATE valid, evidence based outcome measures for populations not addressed in PQRS (e.g. children ) or for patients with diseases without a strong evidence base/smaller economic impact. Many childhood diseases treatments lack a strong evidence base because of historic lack of research funding.

7. “Native Measures” • Amblyopia-20/30 level of vision at age 7 • Strabismus -results of ET surgery- < 10 PD at 8 weeks. • Impact of diabetic retinopathy treatments on families and acuity.

8. IRIS Principles • Ophthalmologists own their data. • Ophthalmologists give permission for data to be distributed and reported. • Academy owns aggregated data. • Data protection/security/quality and audits in place.

9. Benefits to Patients & Society • Rapid cycle quality improvement and better outcomes. • Surgical measures include validated patient reported outcomes. • 22 surgical outcome measures including five for children ( amblyopia and surgical esotropia). • Individual physician level public reporting of outcomes two years after introduction of a measure. • Measures address adults and children; surgical interventions, biologics and chronic disease. • Ability to address disparities in care.

10. Benefits to Profession • Infrastructure for specialty registries-AMD, macular holes, cataract, corneal graft, strabismus, glaucoma devices and drugs • Drug and device surveillance • Demonstrate value of our services • CER & Clinical research.

11. Benefits to Professionals • Quality improvement • Benchmark performance-real time feedback • Improve performance and patient outcomes • Maintenance of certification/licensure • Meet requirements for MOC/MOL-PIMS loaded into registry and can be extracted electronically for ABO submission. • Financial compensation • Receive payment incentives/avoid payment penalties • Meaningful use for EHRs

12. The Value of IRIS™ Registry Satisfy multiple regulatory requirements by providing data to one entity: the IRIS™ Registry.

13. Research and Registries • IRIS is an outpatient clinical registry with the ability to follow patients longitudinally using probabilistic matching (94%). Many facility based registries record the short term evaluation of devices and procedures but are unable to measure the impact on the natural course of disease: IRIS will.

14. Clinical research and registries • Aggregated data allows researchers to identify correlations related to outcomes and develop predictive risk assessment models and questions for further inquiry. Can measure “real world” impact of RCT recommendations on heterogeneous populations.

15. Factors Increasing Membership Acceptance • NO FEE!! • Little impact on patient flow-high EHR adoption • Acceptance by subspecialties and academe • Meaningful measures beyond PQRS/NQF • Regulatory impact

16. Launch Goal-March 2014 • 2200 ophthalmologists by 2017 with 18 million patients

17. Status of IRIS RegistryJuly 4, 2014 • Contracted • 4,486 physicians • Expressing Interest • 7,634 physicians from 1401 practices • Mapped to their EHR (24 vendors) • 1549 physicians from 316 practices • Number of Patient Visits -8.1M visits representing 2.44 M patients • 38M patients in 2017!

18. QCDR “Issues” • THERE IS NO EHR INTEROPERABILITY!!! Thus need for a systems integrator. • Cost is prohibitive • Regulatory failure to ensure registry access to EHR data from academic centers- epic problem. • Tying QCDR to rapidly changing PQRS requirements-nine measures in three domains-dramatically devours registry resources needed to develop analytics and new outcome measures.

19. “Issues” • 2014 NPRM-unreasonable time line for public reporting-same year as measure introduction eliminates needed benchmarks and chance for improvement prior to reporting.

20. Thank you! wlrich3md@gmail.com