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.
– Direct: 512.826.2938 (CST)
• Surveillance Complaints
– [email protected] or
• General EHR questions