Don’t Get Certifiable Dealing

with EHR Certification: What

to Know about the New ONC

Criteria and MU Stage 3

Drummond Group

Agenda

• Meaningful Use – Dead or Alive?

• Meaningful Use – 2015-2017

• Meaningful Use – 2018 (Stage 3)

• Meaningful Use – 2019 and Beyond (MIPS)

• ONC Certification Criteria (2015 Edition)

• Timing and Major Impacts

Drummond Group

• We have been testing and certifying software

systems for over 15 years.

• Largest testing and certifying body of unique EHR

vendors and products.

• Accredited by the DEA for electronic prescribing of

controlled substances (EPCS) and beginning

EPCS certification testing now.

• Outside of Healthcare, we are the main certifying

body for Retail supply chains (e.g. Wal-Mart,

Amazon, Procter & Gamble, Target, etc.) both in

Secure Data Exchange and Item Data

Synchronization.

Meaningful Use Dead?• In January speech, Andy Slavitt, Acting

Administrator of CMS (i.e., head of CMS), made

some strong statements.

– “…we are now in the process of ending Meaningful

Use and moving to a new regime culminating with the

MACRA implementation.”

– “The Meaningful Use program as it has existed, will

now be effectively over and replaced with something

better.”

– MACRA…is a program that brings pay for value into

the mainstream through something called the Merit-

based incentive program, which compels us to

measure physicians on four categories: quality, cost,

the use of technology, and practice improvement.

But what he was really saying…• “…now in the process of ending Meaningful Use…”

– We are following Congressional legislation signed last year

into law to establish MACRA to move Meaningful Use and

other programs under MIPS which we indicated we were

doing when we released MU Stage 3 Final Rule last year.

• “The Meaningful Use program as it has existed, will now be

effectively over and…”

– Changing the current incentive payment system based

solely on meeting analytic measures with…

• “…replaced with something better…”

– New process called MIPS which is a more comprehensive

program for incentive payments which utilizes some

meaningful use analytics measure along with other factors

for positive or negative payment adjustments.

MACRA and MIPS

• Medicare Access and CHIP Reauthorization Act of 2015

(MACRA).

• Ended the sustainable growth rate (SGR) annual “Doc Fix”

(part of Balanced Budget Act of 1997) to ensure yearly

increase in the expense per Medicare beneficiary did not

exceed the growth in GDP (but always had to be annually

delayed).

• Implemented Merit-Based Incentive Payment System (MIPS)

which consolidates meaningful use (MU), the Physician

Quality Reporting System (PQRS), and the Value-Based

Payment Modifier (VBPM) into a single program.

• Still has a positive/negative payment adjustment based on

formula which uses categories of quality, resource use,

meaningful use of certified EHR technology and clinical

practice improvement activities.

MACRA and MIPS Timeline

Aligns with CMS MU Stage 3 Final Rule• MACRA and MIPS mentioned several times in the MU Final

Rule Stage 3.

– “The enactment of MACRA has altered the EHR Incentive

Programs such that the existing Medicare payment

adjustment for EPs under 1848(a)(7)(A) of the Act will end in

CY 2018 and be incorporated under MIPS beginning in CY

2019.”

• CMS has asked for further comments on Stage 3 transition to

MIPS and may issue an updated Final Rule this year.

• NPRM for MIPS due by mid-2016.

• Bottom line: MU is not ending but being improved so that

incentive payments are more focused on quality and care

delivery than solely analytic measures (but still part of the

system.)

CMS MU in 2015-17• For calendar year (CY) 2015, reporting period would be continuous

90-days for all participants, new and returning.

• For CY 2016, reporting period for returning participants would be full

calendar year but a continuous 90-days for new participants.

• For CY 2017, reporting period full calendar year for all participants,

new and returning.

• Starting in CY 2015, several MU measures would be dropped (see

Stage 3 slides). This is aligning with the Stage 3 to streamline the

MU measures for all stages of MU.

• In CY 2015, everyone uses Modified Stage 2 measures with some

provisions for those who were scheduled to be in Stage 1.

• In CY 2016, everyone uses Modified Stage 2.

• In CY 2017, everyone has option of Modified Stage 2 or Stage 3.

• Aligning calendar year reporting for EHs/CAHs with EPs on January

1 to Dec 31.

• EHR technology certified to 2014 Edition can be used in 2015-2017.

By 2018, only 2015 Edition certification will be allowed.

CMS Stage 3– Pt 1• Stage 3 is intended to be final stage of MU.

• Goal is to streamline and simplify MU program through

changes in reporting period, removing “topped out” measures

and unifying providers on common measures.

• EPs/EHs will have option to start Stage 3 in 2017.

• In CY 2018, everyone is on Stage 3, regardless of when they

started MU.

• In CY 2018 and beyond, the reporting period will be a full

calendar year for all participants, both new and returning.

• Many different changes ahead, but a few high level changes

are described in the next slides that impact ONC certification.

CMS Stage 3 – Pt 2• Focused on 8 main objectives and supported by measures

– Privacy and Security

– ePrescribing

– Clinical Decision Support (including Drug-drug/drug-allergy alerts)

– CPOE

– Patient Access: Timely Access (VDT) and Patient Education

– Patient Engagement: VDT or EHR-API and Secure Messaging and

Patient generated health information

– Health Information Exchange: Transition of Care and Clinical

Information Reconciliation

– Public Health and Clinical Data Registry Reporting

• EPs choose 2 out of 5 related measures

• EHs/CAHs choose 4 out of 6 related measures.

CMS Stage 3 – Pt 3• Several measures are to be dropped because they are

“topped out” (i.e., measures that are no longer useful in

gauging performance):

– Record Demographics

– Record Vital Signs

– Record Smoking Status

– Clinical Summaries

– Incorporate Lab Results

– Patient List

– Patient Reminders

– Electronic Notes

– Imaging Results

– Family Health History

– eMAR

– Advanced Directives

– Labs to EP

2015 Edition• ONC’s proposed rule can be viewed as addressing two

different aspects of the program.

– First is the criteria required by EHR systems, like problem list or e-

Prescribing.

– Second is dealing with the program itself covering things which are

primarily associated with ACBs/ATLs but also impact EHR vendors,

like surveillance.

2015 Edition Criteria – Not just for MU • Making an intentional pivot from being solely aligned with

CMS MU Program. Now, many criteria offered are not

associated with any MU measure.

• Goal is to be able to support programs outside of MU. Some

have already started (e.g., Chronic Care Management).

• The analogy ONC is offering is comparing to a buffet – many

choices but you only pick what you need.

• This approach opens up the ONC Certification Criteria to be

used in other areas besides Meaningful Use which is positive,

but the challenge is added complexity for those primarily

focused on Meaningful Use compliance.

2015 Edition Criteria – Overview• Similar in layout to 2014 Edition

– 315.a – Clinical (e.g, CPOE)

– 315.b – Care Coordination (e.g., Transition of Care)

– 315.c – CQMs

– 315.d – Privacy and Security

– 315.e – Patient Engagement (e.g., VDT)

– 315.f – Public Health (e.g, Immunizations)

– 315.g – Design and Performance (e.g., Automated Measures)

– 315.h – Transport Methods (e.g., Direct)

315.a - Clinical• Major clinical functions

– 315.a.1 – CPOE-Medication

– 315.a.6 – Problems List

• Most unchanged but some differences

– 315.a.5 – Demographics

• Recording sexual orientation and gender identify.

– 315.a.14 – Implantable Device List

• Pacemakers, stents, etc.

• Record serial number of device, expiration date, etc.

315.b – Care Coordination• Many of the “interoperability” capabilities

– 315.b.1 – Transition of Care

– 315.b.2 – Clinical Information Reconciliation

• Significant Changes

– 315.b.1 – Transition of Care

• Enhanced checking of CCDA XML summary record.

– 315.b.3 – ePrescribing

• Several new required capabilities, including fill status and

medication history

– 315.b.6 – Data Export

• Strong emphasis on capability of data being exported out of the

system.

315.c – Clinical Quality Measures• CQMs

– 315.c.1 – Record and Export

– 315.c.2 – Import and Calculate

– 315.c.3 – Report

– 315.c.4 – Filter

• Very similar for end user, but for vendors major change is

requirement of importing in QRDA quality files for CQM

calculation.

• Increase interoperability between CMS electronic submission

tool and the ONC EHR tool.

315.d – Privacy and Security• Very similar to previous certification criteria and largely

unchanged.

– 315.d.1 – Authentication and Authorization

– 315.d.4 – Amendments

– 315.d.5 – Automatic Logoff

• Privacy and Security criteria are now required based on

specific criteria being certified.

– For example, certification of 315.a.X criteria requires the EHR

Module to also be certified to criteria d.1-d.7 but NOT d.8 (Integrity).

– Some limited ways to get exemptions on privacy and security.

315.e – Patient Engagement• 3 criteria and mostly found in patient portals

– 315.e.1 – View, Download and Transmit Patient Data

– 315.e.2 – Secure Messaging

– 315.e.3 – Patient Health Information Capture

• Patient health information capture is just that…identify,

record, and access information directly and electronically

shared by a patient (or authorized representative)

315.f – Public Health• Several more options for public health

– 315.f.1 – Immunization

– 315.f.2 – Syndromic Surveillance

– 315.f.3 – Reportable Labs (Inpatient only)

– 315.f.4 – Cancer Registries

– 315.f.5 – Case Reporting

– 315.f.6 – Antimicrobial Use

– 315.f.7 – Health care surveys

• Ambulatory EHRs typically will just have first two, but more

likely being adopted. Inpatient systems will cover at least four

criteria.

315.g – Design and Performance• Includes several “conditional” criteria where greater

functionality.

– Consolidated CCDA Creation Performance (315.g.6) for criteria

using a CCDA like Transitions of Care (315.b.1)

– Safety-enhanced Design (315.g.3) for criteria required to meet

certain usability reporting like CPOE-Medications (315.a.1).

– Meaningful Use reporting analytics (315.g.1/g.2) for EHR Incentive

Program.

• Major impact: Application Access (API) criteria (315.g.7-g.9).

– APIs allow other systems, especially mobile-based ones, easier

access to patient data.

• Safety-Enhanced Design scope is expanded to included new

criteria, like Demographics and Problem List as well as those

dealing with Medication.

315.h – Transport Methods• Functionality to deliver summary records and transitions of

care.

– 315.h.1 (Direct Protocol)

– 315.h.2 (Direct with Edge Protocol)

• For average end-user, not a big change, but can allow greater

modularity and flexibility in working with different HIEs or

HISPs in sharing data.

2015 Edition Non-MU Criteria• While not specifically required for MU, several criteria are

important and should be considered for certification for many

vendors, especially for certain clinical segments.

– For example, Behavioral Health

• Recording Social, Psychological, and Behavioral Data (a.15)

• Data Segmentation for Privacy to Send/Receive (b.7 and b.8)

– Or, Chronic Care Management

• Care Plan (b.9)

2015 Edition Surveillance – Major Change• ONC has made significant changes in how ACBs are to

conduct surveillance of certified EHR deployed into

production.

• Minimum of 2% of EHRs certified by an ACB are selected for

randomized, in-the-field surveillance. For each of those

selected EHRs, the ACB conducts in-the-field tests.

• For non-compliances related to the certification criteria found

at the customer sites, EHR vendor must resolve those issues,

and those non-compliances are made public.

2015 Edition – Other Changes• The “Complete EHR” is being dropped and all certifications

will only be “EHR Module”.

• In proposed rule, greater transparency is required. In 2014

Edition, we had price transparency but 2015 Edition

(proposed requirements) call for not only price transparency

but additional information, such as any contractual limitations

on capacity to access data or required customization to

access, or use of any certified capabilities.

– Also must include hyperlink to access the API documentation and

terms of use related to Application access criteria (315.g.7-g.9).

Major Changes or Points of Emphasis• Interoperability

– Focus on getting data out of EHRs and capable of exchanging and

consuming electronic data records.

• Test procedure and test tool rigor.

– Test tools much more exacting.

– Test time may increase 50%-75%.

• Transparency

– More details on limitations of product via mandatory disclosures on

product websites.

– http://oncchpl.force.com/ehrcert

• Or just Google “ONC CHPL”

Timing and Major Impact

• Meaningful Use is not going away but hopefully

improving (more align with improving care delivery

and not checking off boxes).

• Certification is still required and vendors will be

updating their systems.

– In 2016, likely just see large vendors certified by end

of year. In 2017, more moderate to small vendors

complete testing.

• Vendors seem to be a bit more cautious in starting.– Unsure of CMS / Congress activity.

– More concerned about usability.

Drummond Group Contacts• Website: www.drummondgroup.com

– Register for testing and other information.

• Drummond Academy:

www.drummondacademy.com

– Education site on criteria, MU and other health IT.

• Information on certification testing.

– tracyl@drummondgroup.com

– Direct: 512.826.2938 (CST)

• Surveillance Complaints

– surveillance@drummondgroup.com or

ehrcomplaints@drummondgroup.com

• General EHR questions

– ehr@drummondgroup.com