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Meaningful use. Important shift of mind?. J . Devlies, EuroRec, Belgium. Origi n: Health IT Initiative . Health IT I nitiative as part of the “American Recovery and Reinvestment Act ”
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Meaningful use 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”.
Health IT Initiative • Purpose of the Health IT initiative: • Enhance: • Interoperability • Functionality • Utility • Security of health information technology • Support its meaningful use. • Defined for Medicare & Medicaid Services • ”Electronic Health Record Initiative Program; Proposed Rule” • Published in the Federal Register / Vol. 75, No. 8, January 13, 2010 • 42 CFR Parts 412, et al.
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.
Important mind shift • From product oriented approach to a user oriented 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… ProRec – MIM General Assembly - May 26, 2019
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
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
Main Issues • Qualified EHR systems (and interoperable health information technology): specifications and set of criteria • Meaningful use • Certification ProRec – MIM General Assembly - May 26, 2019
Specifications for Qualified EHR systems ProRec – MIM General Assembly - May 26, 2019
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. • Professionalsandhospitals • Functionalityand standards ProRec – MIM General Assembly - May 26, 2019
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. ProRec – MIM General Assembly - May 26, 2019
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 • 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” ProRec – MIM General Assembly - May 26, 2019
Meaning of « criteria » • Certification criteria do not establish requirements for 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. ProRec – MIM General Assembly - May 26, 2019
Two examples of « objectives » • Maintain an up-to-date problem list of current and active diagnoses 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 » ProRec – MIM General Assembly - May 26, 2019
Objective: problem list For eligibleprofessionals For eligiblehospitals • 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 • 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 ProRec – MIM General Assembly - May 26, 2019
Objective: demographics > criteria For eligibleprofessionals For eligiblehospitals • Enable a user to electronically record, modify and retrieve patient demographic data including preferred language, insurance type, gender, race, ethnicity and date of birth. • Enable a user to electronically 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. ProRec – MIM General Assembly - May 26, 2019
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. • … 10. Record disclosures made for treatment, payment and health care operations in accordance with the standard specified in Table 2B row 6. ProRec – MIM General Assembly - May 26, 2019
How it looks… ProRec – MIM General Assembly - May 26, 2019
“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 ”. ProRec – MIM General Assembly - May 26, 2019
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
Standards • Certified EHR Technology has to becomplyingwithadopted standards. • Categories of standards • Vocabulary standards • Content Exchange Standards • Transport Standards • Privacy and Security Standards ProRec – MIM General Assembly - May 26, 2019
Sample of « content standards » ProRec – MIM General Assembly - May 26, 2019
Privacy & Security Standards ProRec – MIM General Assembly - May 26, 2019
Meaningful use… how defined? ProRec – MIM General Assembly - May 26, 2019
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. ProRec – MIM General Assembly - May 26, 2019
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 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. • …. ProRec – MIM General Assembly - May 26, 2019
How it looks… ProRec – MIM General Assembly - May 26, 2019
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. ProRec – MIM General Assembly - May 26, 2019
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 • Hysterectomy rates • 30 day readmission rate • 30 day readmission following deliveries • Number of repeat CT scans within 60 days…. ProRec – MIM General Assembly - May 26, 2019
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. ProRec – MIM General Assembly - May 26, 2019
More specialisedexamples • % 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. ProRec – MIM General Assembly - May 26, 2019
Alsospecialisedmeasurements • % 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 » ProRec – MIM General Assembly - May 26, 2019
How it looks… ProRec – MIM General Assembly - May 26, 2019
And… ProRec – MIM General Assembly - May 26, 2019
All Practices ProRec – MIM General Assembly - May 26, 2019
Primary Care (1) ProRec – MIM General Assembly - May 26, 2019
Primary Care (2) ProRec – MIM General Assembly - May 26, 2019
Cardiology ProRec – MIM General Assembly - May 26, 2019
ElectronicSubmission • Specifications for electronic submission available for 5 chronic disease measures and 4 prevention issues. • Available on: • http://www.cms.hhs.gov/PQRI/20_AlternativeReportingMechanisms.asp#TopOfPage. ProRec – MIM General Assembly - May 26, 2019
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. ProRec – MIM General Assembly - May 26, 2019
Examples for eligible hospitals ProRec – MIM General Assembly - May 26, 2019
Expectedfrom 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 ProRec – MIM General Assembly - May 26, 2019
Certification of health information technology ProRec – MIM General Assembly - May 26, 2019
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.html • NIST seeks public feed back on the test methods on hit-tst-fdbk@nist.fgov ProRec – MIM General Assembly - May 26, 2019
Three different approaches • Complete EHR systems • EHR Modules separately (complete set to be certified?) • ‘Project’ certification (in-house developments…) ProRec – MIM General Assembly - May 26, 2019
Test Procedures published ! ProRec – MIM General Assembly - May 26, 2019
Content of a Test Procedure • 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) ProRec – MIM General Assembly - May 26, 2019
Impact analysis (cost for market) • Legal requirement: 3 years: cost for preparation • CCHIT Certified Complete EHR’s – Amb. 65 $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 ProRec – MIM General Assembly - May 26, 2019
Conclusions • Realistic goals? • Realistic timing? • Anyway ambitious • Anyway the direction we need to go • If they succeed… where will Europe be? ProRec – MIM General Assembly - May 26, 2019