A9133-101479-E1-4A00 Copyright © 2012 Siemens Medical Solutions USA, Inc. All rights reserved. DVHIMSS Summer Education Program Stage 2 and Regulatory Update Peg Meadow Director, Government & Industry Affairs, Siemens Healthcare June 14, 2012
Mar 28, 2015
A9133-101479-E1-4A00 Copyright © 2012 Siemens Medical Solutions USA, Inc. All rights reserved.
DVHIMSS Summer Education ProgramStage 2 and Regulatory Update
Peg MeadowDirector, Government & Industry Affairs, Siemens HealthcareJune 14, 2012
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A global company With a local footprint in over 190 countries
1847 Founding of 'Telegraphen-Bauanstalt von Siemens & Halske' in Berlin
1850 First international sales agency in London
1853 Office opens in St. Petersburg, Russia
1904 First permanent office in China
1905 Founding of Siemens do Brasil
1924 Founding of Siemens India Ltd.
1961 Exports exceed 1 billion DM for first time
1968 Siemens passes the 100-country mark
1970 Founding of Siemens Corporation, USA
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Energy
Divisions Fossil Power
Generation Wind Power Solar & Hydro Oil & Gas Energy Service Power
Transmission
Healthcare
Divisions Imaging &
Therapy Systems Clinical Products Diagnostics Customer
Solutions (HIT)
Infrastructure & Cities
Divisions Rail Systems Mobility and
Logistics Low and Medium
Voltage Smart Grid Building
Technologies
OSRAM*
Industry
Divisions Industry
Automation Drive
Technologies Customer
Services
Siemens Sectors and Divisions
* In March 2011, Siemens announced its intention to publicly list OSRAM and, as an anchor shareholder, to hold a minority stake in OSRAM AG over the long term
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Siemens in the U.S. Is Home to NineWorldwide Businesses/Divisions
HealthcareOncology Care
Concord, CA
HealthcareUltrasound
Mountain View, CA
IndustryPLM (Product Lifecycle Mgt.)
Plano, TX
IndustryVAI MetalsWorcester, MA
IndustryWater Tech.Warrendale, PA
HealthcareHealth ServicesMalvern, PA
EnergyEnergy ServiceOrlando, FL
HealthcareDiagnosticsTarrytown, NY
HealthcareMolecular Imaging
Hoffman Estates, IL
Siemens Employs Over 60,000 People in All 50 States
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American Recovery & Reinvestment Act (ARRA)HITECH – February 17, 2009
First Steps
Adoption of certified EHRs
Meaningful use of EHRs
Incentive payments to eligible professionals and hospitals
Investment in nationwide HIT infrastructure
Grant money for demonstration projects
The Intended Destination
High quality, safe, effective, and equitable care for all
Seamless patient-centric care
Realigned incentives and measures that foster prevention, intervention, coordination, effectiveness
Regional clinical information interoperability on a national backbone
“The goals are quality and efficiency…If we encourage better performance, then physicians are going to find ways to improve. And health information technology is one crucial way to do that.”
David Blumenthal MD, MPP National Coordinator for Health Information Technology, ONC
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ARRA HITECH Framework for Meaningful Use of Electronic Health Records (EHRs) - $30B/Program
Blumenthal D. N Engl J Med 2009;10.1056/NEJMp0912825
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ONC (Office of the National Coordinator) FTEs
020406080
100120140160180200
FY 09 FY 10 FY 11 FY 12est
ONC FTEs
32
84
149
189
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HITECH Meaningful Use and the Affordable Care ActThe Market Will Develop in Two Waves
2009 2013 2017
Meaningful Use
Affordable Care Act
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ARRA HITECH EHR Incentive $$$$$ - BASICSAn eligible provider using a certified EHR and demonstrating meaningful use qualifies for $$$
Eligible Hospitals / Critical Access Hospitals (EH/CAH) Medicare AND Medicaid Incentive Funds For Medicare,
Four Consecutive Payment Years EH Must start in 2011, 2012, 2013 for Full Payment CAH must start in 2011 or 2012 for Full Payment
Penalties begin in 2015 if not a meaningful user, increase over time, and remain in force
Fiscal Year boundaries
Eligible Professional (EP) Medicare OR Medicaid Incentive Funds For Medicare,
Five Consecutive Payment Years Must start in 2011 or 2012 for Full Payment
Penalties for those who are not meaningful users beginning in 2015 that increase over time
Calendar Year
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Achieving Meaningful Use in Stages
SOURCE:
HIT-enabled Health Reform
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Health Outcomes Policy Priorities*
Ensure privacy and security protections
Improve
population
health
Engage patients and families
Improve care coordination
Increase quality, safety, efficiency, and reduce health disparities
*Adapted from National Priorities Partnership. National Priorities and Goals: Aligning Our Efforts to Transform America’s Healthcare. Washington, DC: National Quality Forum; 2008.
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What Defines the ARRA HITECH Process?
“Meaningful Use”* Final Rule(CMS)
Test Tools & Procedures
Standard & Criteria Final Rule(ONC)
Certification Process Final Rule(ONC)
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HIT Policy CommitteeMeaningful Use Workgroup
HIT Policy/ Standards
Committees
Consumer/Patient Groups, Employers, Government, Multi-stakeholder Groups, Providers, Vendors
HITPC MU Work GroupPaul Tang, MD Co-Chair, Palo Alto Medical Foundation
George Hripcsak, MD Co-Chair, Columbia University
Michael Barr, MD American College of Physicians
David Bates, Brigham & Women’s Hospital
Christine Bechtel, National Partnership for Women & Families
Neil Calman, MD The Institute for Family Health
Tim Cromwell Dept of Veterans Affairs
Art Davidson, MD Denver Public Health
Marty Fattig Nemaha County Hospital
Joe Francis Veterans Administration
Leslie Kelly Hall Healthwise
Yael Harris HRSA
David Lansky Pacific Business Group/Health
Deven McGraw Center/Democracy & Technology
Greg Pace Social Security Administration
Latanya Sweeney Carnegie Mellon University
Robert Tagalicod CMS/HHS
Charlene Underwood, Siemens
Amy Zimmerman Rhode Island Office of Health & Human Services
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Trends In Year-To-Date Payments From May 2011 To April 2012 ($ Millions)
Data from CMS, as of April, 2012
0400800
12001600200024002800320036004000440048005200
Medicare 75 107 149 263 357 528 920 1,384 1,6992,0502,392 2,688
Medicaid 115 166 248 389 503 712 916 1,149 1,4201,8002,092 2,342
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr
$190$273
$397 $652 $860$1,239
$1,836
$2,533
$3,119
$4,484
$3,850
$5,030
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Actual Year-To-Date Spending vs. Projections
Core HIS ComponentsData from CMS, as of April, 2012
Actual SpendingIn FY 2011
Paid Thru 4/12 CMS Projection for FY 2011
CBO ScoreFor FY 2011
$860.1M
$1 to 2.8B
$5.03B$4.7B
Medicaid and Medicare EHR Incentive Spending In 2011Actual Year-To-Date Spending versus Projections
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Actual Providers Paid & Amount Paid Through April 2012
Core HIS ComponentsData from CMS, as of April 30, 2012
Providers Paid Amount Paid Program-to-Date Program-to-Date
Medicare Eligible Professionals 56,214 $953,388,119
Medicaid Eligible Professionals 35,040 $735,578,046
Eligible Hospitals 2,843** $3,341,140,043 Total 94,097 $5,030,106,208
** 2843 – 566 (Dups paid by both) = 2101/5,011 is 42% of EHs whereas 949/ 5,011 EHs who received Medicare funds only for achieving meaningful use, represents 19%.
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Congratulations to Siemens Customers Who Have Achieved Stage 1 MU - 36 enterprises and 62 facilities June 6, 2012 2012
• Alegent HealthAlegent Health
• Altoona Regional Health SystemAltoona Regional Health System
• John D. Archbold Memorial HospitalJohn D. Archbold Memorial Hospital
• Bethesda Memorial HospitalBethesda Memorial Hospital
• Caldwell Memorial HospitalCaldwell Memorial Hospital
• Caromont Memorial Health, Inc.Caromont Memorial Health, Inc.
• Catholic Health SystemCatholic Health System
• CentraState Medical CenterCentraState Medical Center
• Champlain ValleyChamplain Valley
• Clearfield HospitalClearfield Hospital
• Crozer Keystone Health SystemCrozer Keystone Health System
• Danbury HospitalDanbury Hospital
• Ellis MedicineEllis Medicine
• EMH HealthcareEMH Healthcare
• Faith Regional Health ServicesFaith Regional Health Services
• Grenada Lake Medical CenterGrenada Lake Medical Center
• HealthAlliance HospitalHealthAlliance Hospital
• LifespanLifespan
• Main Line HealthMain Line Health
• MedCentral Health SystemMedCentral Health System
• Mercy Health PartnersMercy Health Partners
• Meridian Health SystemMeridian Health System
• Nason HospitalNason Hospital
• Nebraska Heart Hospital, Inc. Nebraska Heart Hospital, Inc.
• Niagara Falls Memorial Medical Center Niagara Falls Memorial Medical Center
• Nix Health Nix Health Care System
• Pinnacle Health SystemPinnacle Health System
• Riverside Health SystemRiverside Health System
• Saint Joseph Hospital (Boston)Saint Joseph Hospital (Boston)
• St. Joseph’s Hospital and Med Ctr St. Joseph’s Hospital and Med Ctr
• South Jersey Health SystemSouth Jersey Health System
• Temple University Health (Jeanes) Temple University Health (Jeanes)
• Texas Regional Medical CenterTexas Regional Medical Center
• Westchester Medical CenterWestchester Medical Center
• Winthrop University HospitalWinthrop University Hospital
• Wyoming Valley Health Care SystemWyoming Valley Health Care System
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Trends in Hospital EHR Adoption Show Increasing Adoption but Low Penetration of Full Function
Percent of Non-Federal Acute Care Hospitals With Adoption of EHR Systems By Level of
Functionality: 2008 - 2011
40%
35%
30%
25%
20%
15%
10%
5%
0%2008 2009 2010 2011
13.4%16.1%* 19.1%*
34.8%*Comprehensive EHR
Basic EHR With Clinician Notes
Basic EHR Without Clinician Notes
*Significantly different from previous year.Source: ONC/AHA, AHA Annual Survey Information Technology Supplement
1.67.84.0
9.4*
3.9
2.8* 3.6
12.0*
3.5
8.8*
18.8*
7.2*
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Physician Adoption of EHRs has Increased Steadily
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
60%
50%
40%
30%
20%
10%
0%
Any EMR/EHR System
Basic EMR/EHR System
18.2 17.3 17.320.8
23.929.2
34.8
42.048.3
50.756.9
10.511.816.9
21.824.9
33.8
Source: CDC/NCHS, National Ambulatory Medical Care Survey
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However, Physician EHR Adoption is Uneven
Source: Rao, SR, et al. JAMIA, May 2011.
1-2 Physicians
40
35
30
25
20
15
10
5
03-5 Physicians 6-10 Physicians 11+ Physicians
25
3
11
6
19
13
26Fully Functional EHR
Basic EHR
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Rollout of Meaningful Use Stage 2 Timeline
Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec Q1 Q2
January 13HIT Policy Committee (HIT-PC) – Meaningful Use (MU) Workgroup issued a request for input on Draft Objectives/ Measures for Stage 2.
2Q 2012?CMS and ONC publish Final Rules.
March – JuneMU Workgroup prepared recommendations to the HIT-PC which will then modify/ approve and send to CMS. Approved on June 8th.
September – 1Q 2012CMS and ONC formulate proposed rules for objectives, measures, standards, and certification criteria.
June – SeptemberHIT Standards Committee identifies standards and certification criteria.
March 7, 2012 Federal RegisterCMS Proposed Rule (EHR Incentive Program) and ONC Proposed Rule (Standards & Certification Criteria).
2011 2012
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Meaningful Use Stage 2: Two Proposed Rules
CMS Medicare and Medicaid Programs; Electronic Health Record Incentive Program – Stage 2 Link to Federal Register 3/7/12 Overview
Key Summary Points Timeline Change
Objectives/Measures Clinical Quality Measures Payment Adjustments Appeal Process Medicaid EHR Incentive Program General Information/Stats
ONC Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology Link to Federal Register 3/7/12 Standards & Certification
Interoperability Privacy & Security Usability/Patient Safety
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Meaningful Use Stage 2: Two Additional Documents Published
CMS Medicare and Medicaid Programs; Electronic Health Record Incentive Program – Stage 2 CORRECTIONS – 4/18/12
5/2/12 NIST releases EHR Technical Evaluation, Testing, and Validation of the Usability of EHRs (100+ pgs)
Rationale for EHR Usability Protocol (EUP) and outlines procedures for design evaluation and human user performance testing of EHR systems.
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Proposed Timeline Change: Stage of MU Criteria by First Payment Year
1st Year 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
2011 1 1 1 2 2 3 3 TBD TBD TBD TBD
2012 1 1 2 2 3 3 TBD TBD TBD TBD
2013 1 1 2 2 3 3 TBD TBD TBD
2014 1 1 2 2 3 3 TBD TBD
2015 1 1 2 2 3 3 TBD
2016 1 1 2 2 3 3
2017 1 1 2 2 3
Red line indicates payment adjustments beginning in FY 2015
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EHs/CAHs: July 1, 2014 (90-day reporting period must begin by April 3, 2014)
Subsection (d) Hospital Payment Adjustments
2015 2016 2017 2018 2019 2020+
% Decrease 25% 50% 75% 75% 75% 75%
% DECREASE IN THE PERCENTAGE INCREASE TO THE IPPS PAYMENTRATE THAT THE HOSPITAL WOULD OTHERWISE RECEIVE FOR THAT YEAR
• For example if the increase to IPPS for 2015 was 2% than a hospital subject to the payment adjustment would only receive a 1.5% increase
Source: CMS at HIMSS12Table 13: CMS NPRM
To avoid Payment Adjustments EHs/CAHs must first meet MU by July 1, 2014 (90-day reporting period must begin by April 3, 2014)
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EP Payment Adjustments
2015 2016 2017 2018 2019 2020+EP is not subject to the
payment adjustment for e-Rx in 2014 99% 98% 97% 96% 95% 95%
EP is subject to the payment adjustment for e-Rx in 2014 98% 98% 97% 96% 95% 95%
% ADJUSTMENT ASSUMING LESS THAN 75 PERCENT OF EPs ARE MEANINGFUL EHR USERS FOR CY 2018 AND SUBSEQUENT YEARS
% ADJUSTMENT ASSUMING MORE THAN 75 PERCENT OF EPs ARE MEANINGFUL EHR USERS FOR CY 2018 AND SUBSEQUENT YEARS
2015 2016 2017 2018 2019 2020+EP is not subject to the payment adjustment for e-Rx in 2014 99% 98% 97% 97% 97% 97%EP is subject to the payment adjustment for e-Rx in 2014 98% 98% 97% 97% 97% 97%
Source: CMS at HIMSS12
To avoid Payment Adjustments EPs must first meet MU by 10/1, 2014 (90-day reporting must begin by 7/ 3, 2014)
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Proposed Meaningful Use Objectives
Eligible Professionals15 core objectives
5 of 10 menu objectives20 total objectives
Eligible Hospitals & CAHs14 core objectives
5 of 10 menu objectives19 total objectives
Eligible Professionals17 core objectives
3 of 5 menu objectives20 total objectives
Eligible Hospitals & CAHs16 core objectives
2 of 4 menu objectives18 total objectives
Source: CMS at HIMSS12
Stage 1 Proposed Stage 2
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Proposed Changes to Stage 1 Effective 2013:Included in Stage 2 Proposed Rules
“Old” 2011 Edition Objective/Measure
“New” 2014 Edition Objective/Measure
Timeframe Required
CPOE Denominator: unique patient with at least one
medication in their med list
Denominator: number of orders during the EHR reporting period
Optional in 2013. Required in 2014+
Vital Signs Age Limits: Age 2 for blood pressure & height/weight
Age Limits: Age 3 for blood pressure. No age limit for
height/weight.
Optional in 2013. Required in 2014+
Vital Signs Exclusion: All three elements not relevant to scope of
practice
Exclusion: Allow BP to be separated from height/weight.
Optional in 2013. Required in 2014+
Test of Health Information Exchange: One test of electronic
transmission of key clinical information
Requirement removed effective 2013
Effective 2013
E-Copy Objective: Provide patients with e-copy of health
information upon request
Online Access Objective: Provide electronic access to health
information
Replacement objective: Provide patients the ability to view online,
download and transmit their health information
Required in 2014+
Public Health Objectives: Immunizations, Reportable Labs,
Syndromic Surveillance
Addition of ‘’except where prohibited’’ to all three.
Effective 2013
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Proposed Clinical Quality Measures
Eligible Professionals3 core OR 3 alt. core CQMs
plus3 menu CQMs6 total CQMs
Eligible Hospitals & CAHs15 total CQMs
Eligible Professionals1a) 12 CQMs (> 1 per domain)1b) 11 core + 1 menu CQMs2) PQRS or Group Reporting
12 total CQMs
Eligible Hospitals & CAHs24 CQMs (> 1 per domain)
24 total CQMs
Align with ONC’s 2011 Edition Certification Align with ONC’s 2014 Edition Certification
Stage 1 Proposed Stage 2
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Additional Reference Information - Hidden Slides in Appendix
Additions/Changes/Deletions comparing Stage 2 to Stage 1 per each of the five Health Policy Outcomes (5 Slides)
Stage 2 Objective and Measures Detail with Stage 1 (8 Slides)
Clinical Quality Measures: Eligible Hospitals and CAHs (1 Slide) 49 Proposed Measures which includes 15 from Stage 1 (24 Required)
Reporting and Reporting Methods
Clinical Quality Measures: EP Reporting Options (1 Slide) 125 Proposed Measures includes 41 from Stage 1 (12 Required)
Reporting Options, Reporting Methods and Group Reporting
Vocabulary Standards (1 Slide)
Consolidated CDA Sample with new data sections (1 Slide)
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Additions: Medication tracking from order to administration using
assistive technology - EHsEHs ePrescribing (for discharge prescriptions) - EH menuEH menu set Image results and information accessible - EP and EH EP and EH
menu setmenu set Record patient family health history as structured data
- EP and EH menu setEP and EH menu setChanges: Thresholds increases/changes: CPOE, demographics,
ePrescribing for EPsEPs, vital signs, smoking status, preventative reminders for EPsEPs
Lab and Radiology ordering required for CPOE Age requirements changed: Blood pressure, growth
charts Clinical Decision support rules increased from 1 to 5 and
expected to support CQMs Consolidated Objectives: Drug-drug and drug-allergy
checks, problem list, medication list, medication allergy list, drug formulary check
Reporting Clinical Quality Measures separated from MU objectives
Increase quality, safety, efficiency, and reduce health disparities ** (stage 2 compared to Stage 1) - SEE APPENDIX
**Health Outcomes Policy Priorities
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Stage 2 Objectives and Measures – SEE APPENDIX
HOPP Stage 2 Objectives Stage 2 Measures
Eligible Professionals Eligible Hospitals and CAHs
Core Set1 Use computerized provider
order entry (CPOE) for medication, laboratory and radiology orders directly entered by any licensed healthcare professional who can enter orders into the medical record per State, local and professional guidelines to create the first record of the order.
Use computerized provider order entry (CPOE) for medication, laboratory and radiology orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local and professional guidelines to create the first record of the order.
More than 60 percent of medication, laboratory, and radiology orders created by the EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting period are recorded using CPOE.
Stage 1: More than 30% of unique patients with at least one medication in their medication list seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) have at least one medication order entered using CPOE.
1 Generate and transmit permissible prescriptions electronically (eRx)
More than 65 percent of all permissible prescriptions written by the EP are compared to at least one drug formulary and transmitted electronically using Certified EHR Technology.
Stage 1:More than 40% of all permissible prescriptions written by the EP are transmitted electronically using certified EHR technology.
1 Record the following demographics- Preferred language- Gender- Race- Ethnicity- Date of Birth
Record the following demographics- Preferred language- Gender- Race- Ethnicity- Date of Birth- Date and preliminary cause of death in the event of mortality in the eligible hospital or CAH
More than 80 percent of all unique patients seen by the EP or admitted to the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) have demographics recorded as structured data
Stage 1:More than 50% of all unique patients seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) have demographics recorded as structured data
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Industry Calls for Stage 2 Changes…..
> 400 comments for each NPRM. Many requests for clarifications. Timeframe impact on Final Rules and confusion over “single source of truth.”
Make the transition period from Stage 1 to 2 realistic Requests for 90 Day Reporting for Stage 2 Delay Payment Adjustment reporting period to be in line with FY15
Reduce volume of Objectives/Measures and Quality Measures Actually 17 new to core or new to MU Objectives in Stage 2, some with multiple
measures 174 Quality Measures (49 EH/CAH, 125 EP)
Reduce complexity of 2011/2014 Edition CEHRTs and Stage 1 and 2 Allow use of 2011 Edition until CY 2015 so all will have same opportunity to spend two
years on the same technology. Maintain link between Stage 1 and 2011 CEHRT Edition
Eliminate holding providers responsible for patient’s actions Delete inclusion of ICD-10 and usability metrics Delete or delay to Stage 3 those standards and quality measures that are not
vetted in the industry (i.e. Implementation experience of smoking status and NQF endorsement of measures)
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Executive’s Role in Orchestrating Health Reform …
ICD-10 CM
Meaningful Use
Hospital Value-based Purchasing Program
Accountable Care Organizations
Hospital Readmissions
Hospital-acquired Conditions
Payment Bundling
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Links & References
Office of the National Coordinator of Health Information Technology: www.hhs.gov/healthit/
CMS Electronic Health Record Incentive Programs: https://www.cms.gov/EHRIncentivePrograms/
HIMSS Meaningful Use OneSource http://www.himss.org/ASP/topics_meaningfuluse.asp
HealthIT.govhttp://www.healthit.gov/
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Thank You.
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DVHIMSS Summer Education ProgramStage 2 and Regulatory Update APPENDIX
Peg MeadowDirector, Government & Industry Affairs, Siemens HealthcareJune 14, 2012