1. Electronic Health Records – Meaningful Use, Certification, and the Regulatory Rulemaking Process June 18, 2015 Lori Mihalich-Levin,JD lmlevin@aamc.org

2. STATUTE: American Recovery and Reinvestment Act (ARRA) of 2009  Medicare and Medicaid Incentives & Penalties  Tied to “meaningful use” (MU) of electronic health records  Must use “Certified Electronic Health Record Technology” (CEHRT)  Separate rules for hospitals vs. “eligible professionals” REGULATIONS: Implement the statute A bit of history… 2

3. Centers for Medicare and Medicaid Services (CMS)  Issues payment regulations  MU Stages 1, 2, 3 Office of the National Coordinator for Health Information Technology (ONC)  Issues “Certification” regulations  Focus is on standards Two Government Agencies Involved in EHR-Related Regulatory Rulemaking 3

4. Rulemaking Process HIT Policy and Standards Committees Advise Agencies CMS and ONC issue a “proposed rule” Public has 60-day comment window CMS and ONC issue “final rule” For EHR regulations, NO deadlines for agency to issue final rules

5. 2015 Regulations: Three Proposed Rules from CMS & ONC 2015-2017 Modifications – comments were due June 15 MU Stage 3 – comments were due May 29 2015 Edition Health IT – comments were due May 29 Where are we NOW? 5

6. Proposed Stages of Meaningful Use By Payment Year 6

7. 2015 Edition Health IT Rule Proposed rule addresses health disparities Options for social, psychological, and behavioral (SPB) data collection ONC sought feedback AAMC filed comment letter Applauded ONC’s proposal to include certification requirements for SPB data Encouraged rigorous patient and community engagement re: SPB data-collection Offered to partner Next steps? Wait for final rule.