Transcript Slide 1

Important shift of mind?
J. Devlies, EuroRec, Belgium
Origin: Health IT Initiative
 Health IT Initiative as part of the “American Recovery and
Reinvestment Act ”
 “Incentive payment to eligible professionals and hospitals…
that adopt and meaningfully use certified electronic health
record (EHR) technology.”
 The Department of Health and Human Services: Office of the
National Coordinator for Health Information Technology (ONC)
issued:
 “Initial Set of Standards, Implementation Specification and
Certification Criteria for Electronic Health Record Technology.”
 “Rules on the process for organisations to conduct certification
of EHR technology”.
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Health IT Initiative
 Purpose of the Health IT initiative:
 Enhance:
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Interoperability
Functionality
Utility
Security of health information technology
 Support its meaningful use.
 Defined for Medicare & Medicaid Services
 ”Electronic Health Record Initiative Program;
Proposed Rule”
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Published in the Federal Register / Vol. 75, No. 8,
January 13, 2010
42 CFR Parts 412, et al.
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Main regulatory aspects
 Mandatory in order to qualify for incentives an eligible professional or
hospital must :
 Adopt Certified EHR Technology
 Connect certified EHR Technology, providing electronic exchange of health
information
 Demonstrate meaningful use of this technology
 Starting CY 2011
 Incentive is
 Not for hospital based professionals: incentive for the hospital
 $44.000 per physician over 5 years, if started in 2011 or 2012 in Medicare
 $63.750 over 6 years if starting EHR in first year, $42.500 if already using
EHR in Medicaid
 $2M + $200 per discharge (1.150-23.000) for 100% Medicare,
proportionally Medicare/Medicaid, 4 years, degressive
 Eligible Professionals or hospitals not meaningful users of certified EHR
Technology will receive less than 100% of the fee schedule or a reduced
annual payment from CY2015 on.
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Important mind shift
 From product oriented approach to a user oriented
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approach.
From validating the system functionality to measuring its
use.
Including clinical quality measurement in the evaluation
process.
Based on a realistic medium long term vision.
More than words…
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Three Stages of “meaningful use”
 Stage 1 (2011) “focuses on electronically capturing health
information in a coded format...
 to track clinical condition and communicating that information for care
coordination
 implementing clinical decision support tools to facilitate disease and
medication management
 reporting clinical quality measures and public health information”
 Stage 2 (2013) “to encourage the use of health IT for continuous
quality improvement at the point of care and the exchange of
information in the most structured format possible
 Electronic transmission of orders
 Electronic transmission of diagnostic test results
applying to both inpatient and outpatient hospital settings
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Three stages of “meaningful use”
 Stage 3 (2015): “focus on promoting improvements in
quality, safety and efficiency, focusing on
 Decision support for national high priority conditions
 Patient access to self management tools
 Access to comprehensive data
 Improving population health
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Main Issues
 Qualified EHR systems (and interoperable health
information technology): specifications and set of
criteria
 Meaningful use
 Certification
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Specifications for Qualified EHR
systems
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Initial set of criteria
 The initial set of criteria establish the capabilities and
related standards that certified EHR Technology will need
to include in order to, at a minimum, support the
achievement of the proposed meaningful use Stage 1
(2011) by eligible professionals and hospitals, under the
Medicare and Medicaid EHR Initiative Programs.
 Professionals and hospitals
 Functionality and standards
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Definitions
 Standard: a technical, functional, or performance-based
rule, condition, requirement or specification that
stipulates instruyctions, fields, codes, data, material,
characteristics or actions.
 Implementation specification: specific requirements or
instructions for implementing a standard.
 Certification criteria: criteria (1) to establish that HIT
meets applicable standards and implementation
specifications (2) that are used to test and certify that HIT
includes required capabilities.
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Realism
 The initial set of standards, implementation specifications and
certification criteria:
 Beginning of an iterative process to enhance interoperability,
functionality, utility and security of HIT
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Considering maturity, prevalence in the market and implementation
complexity
 Approach is pragmatic but forward looking
 “A high-level interoperability will take time, through
 Harmonisation of information models
 Mapping of vocabularies and code sets”
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Meaning of « criteria »
 Certification criteria do not establish requirements for
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healthcare providers. They are the translation of « stage 1
objectives » into capabilities of the systems to support stage 1
for either eligible professionals or for eligible hospitals.
Criteria are, where applicable, a combination of functional
requirements and referenced standards.
Certification criteria are ‘translated’ into ‘Derived Test
Requirements’
They apply for a Complete EHR as well as for EHR modules.
They apply for ambulatory care as well as for hospital care.
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Two examples of « objectives »
 Maintain an up-to-date problem list of current and active diagnoses
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based on ICD-9-CM or SOMED CT.
Record demographics
---------------In total 26 objectives
4 of them does not have « associated proposed meaning use stage 1
criteria for eligible hospitals »
2 others does not have « associated proposed meaning use stage 1
criteria for eligible professionals »
15 objectives have the same « associated proposed meaning use
stage 1 criteria for eligible professionals and for eligible hospitals »
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Objective: problem list
For eligible professionals
For eligible hospitals
 Enable the user to
 Enable the user to
electronically transmit record,
modify and retrieve patient’s
problem list for longitudinal
care (i.e. over multiple visits) in
accordance with the applicable
standards specified in Table 2A,
row 1
electronically transmit record,
modify and retrieve patient’s
problem list for longitudinal
care (i.e. over multiple visits) in
accordance with the applicable
standards specified in Table 2A,
row 1
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Objective: demographics > criteria
For eligible professionals
For eligible hospitals
 Enable a user to electronically
 Enable a user to electronically
record, modify and retrieve
patient demographic data
including preferred language,
insurance type, gender, race,
ethnicity and date of birth.
record, modify and retrieve
patient demographic data
including preferred language,
insurance type, gender, race,
ethnicity and date of birth, and
date and cause of death in the
event of mortality.
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Sometimes one objective > many
criteria
 “Protect electronic health information created or maintained
by the certified EHR technology through the implementation
of appropriate technical capabilities.”
 10 criteria!
Assign a unique name and/or number for identifying and
tracking user identity controls that permit only authorised
users to access electronic health information.
2. …
10. Record disclosures made for treatment, payment and health
care operations in accordance with the standard specified in
Table 2B row 6.
1.
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How it looks…
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“Qualified EHR”
 “an electronic record of health-related information on an
individual that (A) includes patient demographic and clinical
health information, such as medical history and problem lists
(B) has the capacity (i) to provide clinical decision support (ii)
to support physician order entry (iii) to capture and query
information related to health care quality (iv) to exchange
electronic health information with and integrate such
information from other sources.”
 This definition of Qualified EHR “sets the floor for the
capabilities that certified EHR Technology must include ”.
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Other issues
 ICD-10-CM and ICD-10-PSC mandatory for all HIPAA covered
entities per October 1, 2013
 “Due to our approach of aligning adopted certification criteria
with the proposes definition of meaningful use Stage 1, the
Secretary decided NOT to adopt previously recognised
certification criteria developed in 2006”... read CCHIT.
>> More will follow
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Standards
 Certified EHR Technology has to be complying with
adopted standards.
 Categories of standards
 Vocabulary standards
 Content Exchange Standards
 Transport Standards
 Privacy and Security Standards
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Sample of « content standards »
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Privacy & Security Standards
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Meaningful use… how defined?
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Two sets of measures
 Measures related to the usage of the EHR
system.
 Reporting on Clinical Quality Measures using
EHRs by
 Eligible Professionals
 Eligible Hospitals.
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Use of the system (examples)
 CPOE for 80% of all orders (EP) or 10% (EH)
 Problem list: 80% of unique patients seen by EP or admitted
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have at least one entry (or ‘none’) recorded as structured data.
Medication list: 80% of unique patients seen by EP or admitted
have at least one entry (or ‘none’) recorded as structured data.
Reminders (prevention e.g.): send to at least 50% of unique
patients over 50 years seen by EP.
Smoking status for 80% for unique patients seen by EP or
hospitalised that are 13 years old and older.
….
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How it looks…
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Clinical quality measures reporting
 Outcome (average) reporting, used for claims-based or
for registry-based submission.
 Not required electronically in 2011, well from 2012 on…
Attestation sufficient for 2011.
 Certified EHR systems need to enable that reporting,
compliant to the agreed implementation rules.
 NO clinical / outcome goals / scores defined, at least not
as part of the EHR Technology incentive… most probably
part of « practice incentives » within Medicare / Medicaid
program agreements.
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Clinical quality measurements
 Preference is given to the quality measures endorsed by NQF
(National Quality Forum):
 Previous PQRI measures (Physician Quality Reporting Initiative) most
important ones related to chronic conditions (5) and prevention (9)
 RHQDAPU measures (Reporting Hospital Quality Data for Annual
Payment Update).
 84 different quality « indicators » listed for payment years 2011 and
2012.
 Regrouped per «specialty ».
 Some are listed but not included
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Hysterectomy rates
30 day readmission rate
30 day readmission following deliveries
Number of repeat CT scans within 60 days….
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Examples
 % of diabetes mellitus patients (>18 and <75) with most
recent HbA1c > 9% (NFQ59)
 % of patients >18 with heart failure and LVSD who where
prescribed ACE inhibitor or ARB therapy (NFQ81)
 % of patients > 50 who received influenza immunisation
from Sept. to Feb.
 % of patients (>60 and < 80) who received appropriate
colorectal cancer screening.
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More specialised examples
 % of patients > 18 with new episode MDD (Major
Depressive Disorder) and documented as treated with
antidepressant medication during the entire 84 days
acute treatment phase.
 % of patients > 18 with POAG (Primary Open Angle
Glaucoma) who have an optic nerve head evaluation
within the 12 months.
 % of patients > 18 with ischemic stroke or TIA with
paroxysmal atrial fibrillation who where prescribed an
anticoagulant at discharge.
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Also specialised measurements
 % of final reports within 24 hours of arrival to hospital for
brain CT or MRI for patients with stroke, TIA or intracranial
haemorrhage…
 % of non-cardiac surgical patients > 18 undergoing procedures
with indication for prophylactic antibiotics who received it and
who have an order for discontinuation within 24h of surgical
end time.
 % of patients >18 with hepatitis C who were prescribed
peginterferon and ribavirin therapy within the 12 month
reporting period.
 % of final screening mammograms classified as « probably
benign »
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How it looks…
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And…
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All Practices
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Primary Care (1)
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Primary Care (2)
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Cardiology
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Electronic Submission
 Specifications for electronic submission available for 5
chronic disease measures and 4 prevention issues.
 Available on:
 http://www.cms.hhs.gov/PQRI/20_AlternativeReporting
Mechanisms.asp#TopOfPage.
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Quality measures Eligible Hospitals
 Different set of quality measures to be reported by the
hospitals.
 Can be on « attestation » basis for 2001.
 There might be separate quality measures within the
Medicare & Medicaid programs.
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Examples for eligible hospitals
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Expected from 2013 on…
 Extended set of clinical quality measures
 Additional paediatrics measures
 Long-term care measures
 Additional obstetrics measures
 Dental care / oral health measures
 Additional mental health and substance abuse measures
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Certification of health information
technology
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Certification program
 Voluntary certification of health IT as being in compliance
with meaningful use criteria.
 NIST develops conformance test methods (test
procedures, test data and test tools).
 http://xw2k.nist.gov/healthcare/use_testing/index.ht
ml
 NIST seeks public feed back on the test methods on [email protected]
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Three different approaches
 Complete EHR systems
 EHR Modules separately (complete set to be certified?)
 ‘Project’ certification (in-house developments…)
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Test Procedures published !
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Content of a Test Procedure
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Certification Criterion as is
Informative Test Description
Referenced standards (if applicable)
Normative Test Procedures => Derived Test Requirements
(e.g. record, modify, retrieve)
 For each Derived Test Requirement:
 Required Vendor Information
 Required Test Procedure
 Inspection Test Guide
 Example test data for each of the DTR
 Conformance Test Tools (if appropriate)
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Impact analysis (cost for market)
 Legal requirement: 3 years: cost for preparation
 CCHIT Certified Complete EHR’s – Amb. 65
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$65M
CCHIT Certified Complete EHR’s – Inpat. 15 $20,63M
Never Certified Complete EHR’s – Amb. 8
$19,2M
Never Certified Complete EHR’s – Inpat. 3
$16,5M
EHR Modules 50
$15M
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Conclusions
 Realistic goals?
 Realistic timing?
 Anyway ambitious
 Anyway the direction we need to go
 If they succeed… where will Europe be?
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