2015 Edition Certification NPRM Group 1 - Report Out

Implementation, Certification, and Testing (ICT) Workgroup

April 27, 2015

Liz Johnson, co-chairCris Ross, co-chair

1

2015 Q1 2015 Q2 2015 Q3 2015 Q4

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

FACA Milestones

Kick-off

Final FACA HIT Strategic Plan Comments

FACA Milestone

FACA Interoperability Roadmap Comments

FACA NPRM Comments

FACA workgroups charged with responding to Interoperability Roadmap

FACAs charged with responding to NPRMs

S&I Task Force Recommendations

Estimated timing

Data Provenance Task Force Recommendations

HITPC membership changes

HITSC Milestone 2

Current Membership

Name Organization

Cris Ross, co-chair Mayo

Liz Johnson, co-chair Tenet Healthcare Corporation

Sarah Corley Next Gen

David Kates The Advisory Board Company

Udayan Mandavia iPatientCare

Kyle Meadors Drummond Group Inc.

Rick Moore National Committee for Quality Assurance

Andrey Ostrovsky Care at Hand

Danny Rosenthal Inova Health System

John Travis Cerner Corp.

Steve Waldren American Academy of Family Physicians

Zabrina Gonzaga Lantana

Kevin Brady, Federal Ex officio National Institute of Standards and TechnologyBrett Andriesen, staff lead Office of the National Coordinator for Health IT

3

Meetings Task

April 9, 2015 3:30pm ET • Finalize comments on Interoperability Roadmap V.1

• Overview of Certification NPRM and prepare to comment

April 22, 2015 – HITSC meeting • Interoperability Roadmap V.1 comments to the HITSC

April 27, 2015, 2:00pm ET • Group 1 to comment on Certification NPRM

May 8, 2015 – 12:00 ET • Group 2 to comment on Certification NPRM

May 14, 2015 – 2:00pm ET • Group 3 to comment on Certification NPRM

May 19, 2015 – 9:00am ET • Finalize comments on Certification NPRM

May 20, 2015 – HITSC Meeting • Present Certification NPRM Comments to the HITSC

Implementation Certification & TestingWorkplan

4

5

2015 Edition Certification NPRM

6

Implementation, Certification & Testing NPRM Group 1 Assignments

Group 1 – David Kates (lead), Rick Moore, Kevin Brady

• Costs and Benefits , p.14• Applicability, p.28• Gap Certification Eligibility Table, p.234• Common Clinical Data Set Definition, p.245• Consolidated CDA Creation Performance, p.202• Open Data Certified Health IT Product List (CHPL), p.288• “Removal” of Meaningful Use Measurement Certification Requirements, p.253• The ONC Health IT Certification Program and Health IT Module, p.12

Costs and Benefits

7

Intro to rule: Our estimates indicate that this proposed rule is an economically significant rule as its overall costs for health IT developers may be greater than $100 million in at least one year. We have, therefore, projected the costs and benefits of the proposed rule. The estimated costs expected to be incurred by health IT developers to develop and prepare health IT to be tested and certified in accordance with the 2015 Edition health IT certification criteria (and the standards and implementation specifications they include) are represented in monetary terms in Table 1 below

Comments Summary:

Enumerate quantitative benefits with hard evidence in quality outcomes that criteria aim to improve.o e.g., level of care coordination could be expected to improve as a result of improved

interoperability and reduce avoidable hospital admissions w/ cost reduction of XX.X% by XX date (2020).

Applicability

8

Intro to rule: Section 170.300 establishes the applicability of subpart C – Certification Criteria for Health Information Technology. We propose to revise paragraph (d) of § 170.300 to add in a reference to § 170.315 and revise the parenthetical in the paragraph to say “i.e., apply to any health care setting” instead of “i.e., apply to both ambulatory and inpatient settings.” These proposed revisions would clarify which specific capabilities within a certification criterion included in § 170.315 have general applicability (i.e., apply to any health care setting) or apply only to an inpatient setting or an ambulatory setting

Comments Summary:

ONC should clearly communicate to vendors that there is an ethical and legal obligation to clearly signal to potential buyers precise attributes of MU that the purchased system facilitates achievement.

ONC should proceed cautiously down this path w/ foresight for greater potential for providers to misunderstand the true capabilities of the health IT they purchase for each module.

It will most likely be impossible for some providers to understand which modules would be needed to achieve MU and subsequent incentive payment programs.

Gap Certification Eligibility Table

9

Intro to Rule: Our gap certification policy focuses on the differences between certification criteria that are adopted through rulemaking at different points in time. This allows health IT to be certified to only thedifferences between certification criteria editions rather than requiring health IT to be fully retested and recertified to certification criteria (or capabilities) that remain unchanged from one edition to the next and for which previously acquired test results are sufficient. Under our gap certification policy, “unchanged” criteria are eligible for gap certification, and each ONC-ACB has discretion over whether it will provide the option of gap certification.

Comments Summary:

Simply a naming convention crosswalk, with no gaps identified at this time. When gap certification criteria are proposed, ONC should note the significant burden a

change in standards has in the vendor and industry. ONC should address specifics of transitional requirements for the change in standards to

ensure forward and backward compatibility and be aware of increased testing and cost burdens placed on vendors.

Potential for unintended consequences where production systems break as a result of implementing new criteria.

Common Clinical Data Set Definition

Intro to Rule: We propose to revise the “Common MU Data Set” definition in § 170.102. We propose to change the name to “Common Clinical Data Set,” which aligns with our approach throughout this proposed rule to make the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs. To effectively rename 221 This is required by the HITECH Act under the term “Qualified EHR” and references a foundational set of certified capabilities all EPs, eligible hospitals, and CAHs need to adopt. the Common MU Data Set as the “Common Clinical Data Set,” the Common MU Data Set definition must be removed from the CFR and the “Common Clinical Data Set” definition mustbe added.

Comments Summary:

Appears to be simply a name change. ONC should be clear how it plans to handle 2014 certified technologies with 2015

technologies to ensure compatibility between certified health IT –it could be as simple as stating that vendors must ensure backward and forward compatibility with any/all certified technologies.

Consolidated CDA Creation Performance

11

Intro to Rule: We propose that the C-CDA creation performance certification criterion would focus on and require the following technical outcomes to be met1. Reference C-CDA Match2. Document Template Conformance3. Vocabulary Conformance

Comments Summary: It’s plausible that testing for correct C-CDA syntax created in a system once signifies system

is capable of ongoing performance and requiring testing of that for each functional capability test requiring a CCDA is repetitive and unnecessary.

Syntax checking is only one aspect of interoperability issues.

Semantic check would require production and testing of each C-CDA.

While it appears to lessen burden by only testing the syntax once, may have unintended consequences for semantic interoperability if ONC does not require that the vendor produce each interoperability check to include the correctly formatted message with each test. Having a vendor simply repeat the “performance” of creating a C-CDA is not an undue burden.

Consolidated CDA Creation Performance (Cont’d)

12

Intro to Rule: We propose that the C-CDA creation performance certification criterion would focus on and require the following technical outcomes to be met1. Reference C-CDA Match2. Document Template Conformance3. Vocabulary Conformance

Comments Summary: ONC should minimize the “vagueness” of the interoperability requirement by specifying the “exact”

requirements for each interoperable exchange. This would require ONC to detail the expected option used for each message. Creation and Validation of a C-CDA without this specificity would be meaningless for interoperability.

ONC must ensure optionality in C-CDA is removed by specifying any optional fields.

ONC should have in-place ongoing, post-certification “interoperability” testing for vendors to prove they are maintaining conformance (occasional send of C-CDA to a test system)

Because deployed systems are usually not exact systems as were certified (e.g. at minimum new certificates) , ONC should consider a quick “on-boarding” test to ensure deployed system is compliant by sending a test C-CDA (to same test system).

13

Open Data Certified Health IT Product List (CHPL)

Intro to Rule: We propose to revise the “Common MU Data Set” definition in § 170.102. We propose to change the name to “Common Clinical Data Set,” which aligns with our approach throughout this proposed rule to make the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs

Comments:

No comments

“Removal” of Meaningful Use Measurement Certification Requirements

14

Intro to Rule: We propose to not require ONC-ACBs to certify Health IT Modules to the 2015 Edition“meaningful use measurement” certification criteria (§ 170.315(g)(1) “automated numeratorrecording” and § 170.315(g)(2) “automated measure calculation”). This is a change from priorcertification policy, such as with the certification of technology to the 2014 Edition and therequirements of § 170.550(f)(1). We believe this will make the ONC Health IT Certificationmore accessible to the certification of health IT for other purposes beyond the EHR IncentivePrograms.

Comments:

Unclear how proposed change impacts testing requirement for reporting CQMs. It may be implicit that ONC is not intending to change the CQM reporting and testing

requirements with this rule, but just the non-clinical MU measurements. Suggest that ONC make this proposed change more clear.

The ONC Health IT Certification Program and Health IT Module

15

Intro to Rule: We propose not to require ONC-Authorized Certification Bodies (ACBs) to certify all Health IT Modules to the 2015 Edition “meaningful use measurement” certification criteria (§ 170.315(g)(1) “automated numerator recording” and § 170.315(g)(2) “automated measure calculation”). We note that CMS has proposed to include the 2015 Edition “meaningful use measurement” certification criteria in the CEHRT definition as a unique program requirement for the EHR Incentive Programs.

Comments: Proposal to remove the automated numerator and denominator calculations does not apply to CQM

reporting, as those reporting requirements are covered by different standards. Regarding “field surveillance” of a deployed system, ONC should clearly articulate what such a

surveillance would entail. Positive that it recognizes the deployed versions of a lab-tested system vary in performance from site to

site, though variations are often a result of site-specific configuration issues. Alterations to the “standard” implementation should only require documentation if alterations affect

the achievement of MU or other programs. If ONC does not limit with specificity what is meant by the audit and/or the requirement to document

and report changes to the “standard” deployment of the “lab-tested” system, there will most certainly by undue burden on the vendor, the site, and that may threaten the forward progress of the MU program.

Implementation, Certification & Testing NPRM Assignments

Group 2 – John Travis (lead), Steve Waldren, Udayan Mandavia, Kyle Meadors

Group 3 – Sarah Corley (lead), Danny Rosenthal, Zabrina Gonzaga, Andrey Ostrovsky

Homework due May 4th Homework due May 11th

Report out to workgroup May 8, 2015 – 12:00 ET Report out to workgroup May 14, 2015 – 2:00pm ET

• Base EHR Definitions, p.240• Retesting and Certification, p.197• Safety-enhanced design, p.190• Web Content Accessibility Guidelines, p.164• Design and Performance, p.261• Request for Comment on Summative Testing,

p.196

• Encounter Diagnoses, p.105• Medication Dosing, p.118• Implantable Device List, p.73• Pharmacogenomics Data – Request for Comment,

p.236• There are certification approaches that could

enhance the end-user’s (provider’s) adoption and continued use of health IT implementations that guide prescribing through CDS using pharmacogenomic data

• Data Portability, p.124• Automated Numerator Recording/Calculation,

p.190