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Regulations and
Guidance page
The Government Decides the Changes
CMS (Centers for Medicare and Medicaid Services) www.cms.gov
EHR Incentive Programs
page
Announcements
Dates to Remember
Yearly CQM Requirements
Final Rule
Resources for Participation
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Guidance comes from the Electronic Health Record Incentive Program Final Rule - CMS
But Certification Criteria comes from the current Edition of Health Information Technology (Health IT) Certification Criteria Final Rule - HealthIT.gov
Changes along with every EHR Final Rule
Subsequent Corrections and Clarifications
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“referencing
§§ 170.302, 170.304, and 170.306.”
“we direct readers to
the Stage 2 final rule
published ‘elsewhere’
in the Federal Register
Correction/ Clarification Notices
Changes can be conflicting or require an entire re-work
Sometimes even clarifications are not clear:
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1 Big Challenge Vendors Face:
Interpretation can
be half the battle
Example: CPOE
Denominator Statement:
Number of medication orders created by the EP or authorized providers in the eligible hospital's or CAH's inpatient or emergency department
Count orders placed only by a provider?
What if it’s a ‘written’ order?
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Who Can Document this?
When Can they Document?
Do we need security on it?
Do we need audit logs for it?
Example: NQF 0419
Documentation of Current Medications in the
Medical Record
Told what to do,
Challenge # 2 Vendors Face:
But not To do it HOW
Make a checkbox?
Trigger automatically if
the Reconciliation is
done?
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Certifying Testing Body
Certified by the ONC (Office of the National Coordinator)
Test Event Time Lines
Pre-Test
Documentation
Proctor Sheets
Pre-Test Patient Setup CCDs
Required Vendor
Documentation
Bundles
Guidance
Clarification
Testing Scripts
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Pre-Test Questionnaire 36 Pages
Pre-Certification Survey
Questions about the product itself
Who is the target audience? When was it first developed?
How will you adjust the notifications for both drug-drug and drug allergy?
Please confirm you can provide these in real time during CPOE
Which drug-drug and drug-allergy combination are you going to test?
User Testing and Reporting EHR Usability Test Report – Uses NISTIR 7741, as the
standard for testing
Participants
Participant Forms and Testing Instructions
Test Environment Set-up
Risk Assessments
Stage 2 was 57 pages
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Certification Letters
Vendor Quality Management System
Version Certification Letter
Version User Centered Design Attestation
Safety Enhanced Design
Checklist – 15 pages
Based on a certifiable standard Risk Assessments How you document requirements Internal testing procedures
Vendor Price Transparencies
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Risk Assessments
Clinical Information
Reconciliation
Data Portability
Disaster Recovery
Tamper Resistance
User/Facility
Configuration Options
Transmission Capabilities
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Vendors are already receiving warnings about the difficulty of the 2015 Edition changes
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Through Every Step –
Measure
Analyze
Optimization
Break It
Fix It
Unintended Use
Repeat
Desired Functionality?
Unintended Functionality?
Security
Audit Trail
Storing the information
Retrieving the information
Print Reports/ summary?
Input In >>> Output Out?
Ease of use
Is there an easier way? Intuitive? Access?
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Murphy’s Laws
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After Successful Certification
Changing websites, logos, marketing materials and any other documentation to reflect the current certification
Educating customers on all new requirements/ additions, and changes to existing requirements/ features
Updating user
guides and
training manuals
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Well-Rounded
Closed Looped System
that provides a Whole
Solution
Takes time to develop
whole solutions when the
criteria are constantly
changing
Vendors have to SQUEEZE
in change requests and
desired functionality in-
between required
functionality
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MACRA: Merit-Based
Incentive Payment System
(MIPS) and Alternative
Payment Model (APM)
Incentive programs –
Only 962 pages
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References
https://www.federalregister.gov/articles/2015/10/16/2015-25595/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3-and-modifications
Final Rule- 2015 Edition
CMS EHR Incentive Program https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/index.html
https://www.federalregister.gov/articles/2015/10/16/2015
-25597/2015-edition-health-information-technology-
health-it-certification-criteria-2015-edition-base