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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

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

“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:

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?

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?

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

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

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

Risk Assessments

Clinical Information

Reconciliation

Data Portability

Disaster Recovery

Tamper Resistance

User/Facility

Configuration Options

Transmission Capabilities

Vendors are already receiving warnings about the difficulty of the 2015 Edition changes

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?

Murphy’s Laws

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

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

MACRA: Merit-Based

Incentive Payment System

(MIPS) and Alternative

Payment Model (APM)

Incentive programs –

Only 962 pages

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