Electronic Health Records – Meaningful Use, Certification, and the Regulatory Rulemaking Process

June 18, 2015

Lori Mihalich-Levin,JDlmlevin@aamc.org

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• 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…

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• 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

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

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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?

Proposed Stages of Meaningful Use By Payment YearFirst Payment Year for EP or Hospital

Payment Year & Stage of Meaningful Use

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020+

2011 1 1 1 2 Mod. 2 2 Mod. 2 or 3 (used to

require 3)

3 3 3

2012 1 1 2 Mod. 2 2 Mod. 2 or 3 (used to

require 3)

3 3 3

2013 1 1 Mod. 2 2 Mod. 2 or 3 (used to

require 3)

3 3 3

2014 1 1Mod. 2

2 Mod. 2 or 3 (was 2)

3 3 3

2015 1Mod. 2

1Mod. 2

1, Mod. 2, or 3 (was 2)

3 (used to permit 2)

3 3

2016 1Mod. 2

1, Mod. 2, or 3 (was 1)

3 (used to permit 2)

3 3

2017 1, Mod. 2, or 3 (was 1)

3 (used to permit 1)

3 3

2018 + 3 3 3

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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.