Meaningfull Use - Industry

Meaningf Ind str Perspecti

Perspectivee
Maggie Lohnes, RN, FHIMSS
Chair, HIMSS Public Policy Committee
Western States Health-e Connection Summit
April 12, 2010
 Topics
• What is HIMSS
• Who is the HIMSS Public Policy Committee
• MU Impact to Healthcare Providers
• MU Impact to Vendors
• HIMSS Public Comments for Meaningful Use
• Additional Resources

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 Resources
• Meaningful Use
– HIMSS Recommendations on Meaningful Use
• Standards and Certification Criteria
– HIMSS Recommendations
• Health Insurance Reform
– Health IT Provisions
• Other Items
– FDA and EHRs as Medical Devices
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 HIMSS
• The Healthcare Information and Management Systems
S stems Society
Societ
(HIMSS) is a comprehensive healthcare-stakeholder
membership organization exclusively focused on providing
global leadership for the optimal use of information technology
(IT) and management systems for the betterment of healthcare.

• Founded in 1961 with offices in Chicago,

Chicago Washington D.C.,
DC
Brussels, Singapore, and other locations across the United
States, HIMSS represents more than 23,000 individual
members,, of which 73% work in p patient care deliveryy
settings.

• HIMSS also includes over 380 corporate members and nearly

30 not-for-profit organizations.
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 The HIMSS Public Policy Team
• Board of Directors – Set Policy
• Public Policy Steering Committee (PPSC) –
Make recommendations
– 13 voting
ti members
b – 2 year terms
t
– 4 non-voting members (CHIME, ME/PI Community,
NACHC, and Federal Health Community)
– 3 Board Liaisons (Burde, Keeler, and Paramore)
• HIMSS Government Relations Roundtable (HGRR)
• Chapter
p Advocacyy Roundtable ((CAR))
• HIMSS Business Diversity Roundtable
• HIMSS Affiliate Roundtable
• Legislation/Regulation Review Task Force (LRRTF)
• Individual members and staff
 HIMSS Public Policy Committee
 Chair: Maggie Lohnes,
Lohnes RN,
RN Administrator,
Administrator Clin Info Mgmt,
Mgmt MultiCare Health System
 Vice-Chair: Fred Hannett, MPA, Managing Partner, The Capital Alliance
 Neal Ganguly, FHIMSS, MBA, VP and CIO CentraState Healthcare System
 Bruce Gordon, BA, Program Manager Mitre Corporation
 Jaime Parent
Parent, MA,
MA MS,
MS VP IT Ops & Associate CIO CIO, Rush University Medical Center
 Kathleen Fortney, Director, Business Development Northrop Grumman
 Susan Schade, FHIMSS, CIO Partners Healthcare System
 Carladenise Edwards MS, Ed, PhD, Chief of Staff, Georgia Dept of Community Health
 Hank Fanberg,
Fanberg Technology Advocate Christus
 Ruth Perot, MAT, Executive Director Summit Health
 Herb Smaltz PhD, FHIMSS, CIO Ohio State Medical Center
 Benjamin McLarin, Management Engineering Consultant, Sacramento, California
 HIMSS Staff:
• Dave Roberts, VP Government Relations
• Tom Leary, Senior Director, Federal Affairs
• K. Meredith Taylor, MPH, HIMSS Director, Congressional Affairs
• Tom Keefe,
Keefe Director,
Director State Government Relations

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 HIMSS Public Policy Activities
• Annual Public Policy Summit – 3 “Asks” to Congress

• December 2008 - “A Call to Action: Supporting Healthcare Reform through Health

Information Technology”
Technology Recommendations to the new Congress and Administration
(update for delivery June 2010)

• Strong Chapter Advocacy Liaison program

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 MU Impact to Providers
• “Perfect Storm” of HITECH, State Medicaid Initiatives,
and Healthcare Reform Directives
• Tight implementation lead time for those without
automation
• Capital funding obstacles
• System selection support
• Eligible Provider specialty bias
• Quality reporting validation

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 MU Impact to Vendors
• HIMSS Electronic Health Record Vendor Association (EHRVA) – supported
by HIMSS but operates independently - developed comments (available at
himssehrva.org) with concerns regarding:
• Timelines for implementation, particularly to generate and report quality data
• Finalizing certification process and authorized certificating entities
• Earlier timing for Stage 2 NPRMs -- i.e., by end of 2010
• Refine “all or nothing approach” ; scale back on MU criteria
• Reduce number of quality measures; focus on measures with EMR specs
• Refine certification criteria
• Provide more robust approaches to HIE
• Refine/strengthen standards proposals
• Narrow definition of "hospital-based professionals"
• About the EHR Association: Contact Elizabeth (Liddy) West for more
information ewest123@msn.com 520-730-8212 9
 Meaningful Use –
HIMSS Public Comments
 Five Broad Healthcare Goals for
“Meaningful
Meaningful Use”
Use

1 Improve quality
1. quality, safety
safety, efficiency
efficiency, and reduce
health disparities
g g Patients and Families
2. Engage
3. Improve Care Coordination
4. Ensure adequate privacy and security protections
for Personal Health Info
5. Improve Population and Public Health

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 HIMSS Recommendations on MU
• Incentive Program Eligibility and CCN: Corrects
the unintended impact of using CMS Certification
N b (CCN) to
Numbers t identify
id tif hospitals
h it l for f incentive
i ti
payments.
• Incentive
I ti Program
P Eligibility
Eli ibilit and d POS:
POS Corrects
C t
the NPRM on Hospital-based professionals (HBPs)
to reflect the Congressional intent to consider the
EHR that the provider is using as well as Place of
Service (POS) settings, reducing substantially the
number of professionals who are excluded from
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incentives as HBPs.
 HIMSS Recommendations on MU
• Incentive Program Eligibility – Need Legislative Fix
• Additional eligible professional categories over the course of
the timeline for the Medicare and Medicaid Programs;
Electronic Health Record Incentive Programs on such action
items as:
– Expanding the definition of “meaningful
meaningful user
user”
– Expanding the care delivery setting to encompass more parts of the
continuum of care
– Collectingg standardized clinical pperformance measures as a byproduct
yp
of care delivery and clinician documentation that support workflow
and improve care delivery
– Enhancing programs and funding availability for patient education
offerings
ff i andd the
h advancement
d off personall health
h l h records
d andd how
h to
leverage patients’ personal health information to improve clinical
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outcomes.
 HIMSS Recommendations on MU
• Criteria for Meaningful Use: Streamlines Criteria
for Meaningful
g Use that recognizesg the impact
p on
workflow; places an emphasis on realistic
percentages for metrics; and allows for partial credit
• Quality Metrics for Meaningful Use: Streamlines
the Quality Metrics and ensures the measures can be
h lth IT-enabled
health IT bl d as partt off the
th care process

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 HIMSS Recommendations on MU
• Privacy and Security: Supports the adherence to
existing privacy and security law and regulation
without creating duplicate or redundant regulatory
requirements.
• Health Information Exchange: Supports the
government’s intent to accelerate the use of HIE as
capabilities increase after Stage 1 and suggests the
government place more emphasis on standards-based
HIE in the Stage 2 and 3 MU requirements
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 HIMSS Recommendations on MU
• Certification Criteria: Supports the ability of non
non-
certified technology to be employed to support
certified EHR technology to help providers achieve
meaningful use, so long as the provider has certified
EHR technology.
• Health IT Implementation Timelines: Recognizes
the impending strain on healthcare community from
th potential
the t ti l “Perfect
“P f t Storm”
St ” off health
h lth IT project
j t
timelines required for Meaningful Use and the
associated Standards and Certification Criteria,
Criteria along
with the conversion to ICD-10 and X-12 5010 16
standard.
 Quality Metrics Recommendations
1 Eli
1. Eliminate
i t Core
C Measure
M Set
S t for
f Eligible
Eli ibl
Professionals
2 Include a small number of measures that have been
2.
adequately vetted to ensure they can be captured and
reported through the EHR.
3. Implement an aggressive Quality Measures Testing
Program
g
4. Align current Quality Measure Reporting with new
requirements
q to avoid duplication
p
5. Limit reporting on quality measures in 2011 17
Standards and Certification Criteria
Standards and Certification Criteria IFR
Relevant Themes
• Creates a floor for standards, implementation
specifications and certification criteria for
specifications,
meaningful use.
• Creates specific standards in 2011 in four areas:
1. Vocabulary
2. Content exchange
3. Transporting of information
4
4. Pi
Privacy and
d security
it
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 Standards & Certification Criteria
Recommendations
• Definitions: Seeks clarification on several definitions,
including
– functionality of CPOE (data capture and order creation);

– managing data – recommends Joint Commission

definition

– Venue of Care supports Congressional intent of hospital

hospital-
based professional

• Interoperability
p y in Stage
g I: Requests
q clarification on impact
p
off interoperability
i bili requirements
i andd testing
i andd certification
ifi i
requirements on complete and modular EHRs for Stage I. 20
 Standards & Certification Criteria
Recommendations
• Supports the Adoption of one patient record summary to support
MU Stage II and beyond
– Supports the use of CCD or CCR in Stage I
• Supports a push toward administrative simplification using the
CORE process
CO p ocess
– Supports maturation of the eligibility verification process
based on CORE Phase II by 2014
• Recommends
R d revisiting
i iti the
th ONC Economic
E i Impact
I t Assessment
A t
– Small Business criteria assessment not consistent with
CCHIT data
• Supports ONC efforts to monitor industry developments on
health data security 21
Certification Process
Formulation Of Certification Proposal
1. HIT Policy Committee recommendations
2. Coordination with the HIT Standards and
Certification Criteria Interim Final Rule and the
Medicare and Medicaid Incentive Programs
proposed rule
3. Consultations with NIST
4. Timeliness related to the beginning of the
Medicare and Medicaid EHR Incentive
Programs
Coordination with HIT Standards and Certification
IFR and Medicare/Medicaid EHR Incentive
Proposed Rule
• Third and final element of Department of Health and Human
Services (HHS) coordinated rule makings to define the
meaningful use of Certified EHR Technology and support the
achievement of meaningful use.
• As required by the HITECH Act, eligible professionals and
eligible hospitals must demonstrate meaningful use of certified
EHR technology in order to receive incentive payments under
th Medicare
the M di andd Medicaid
M di id EHR Incentive
I ti programs.
• This proposed rule creates the certification programs under
which Complete EHRs and EHR Modules could be tested and
certified
tifi d andd subsequently
b tl usedd as Certified
C tifi d EHR technology.
t h l
HIT Certification Programs Proposed Rule
• Propose both temporary and permanent certification
programs programs for HIT
– Currently test and certify Complete EHRs and EHR Modules
– In the future, permanent certification program could also
include testingg and certification of other types
yp and aspects
p of
HIT.
– This proposed rule marks the beginning of the formal notice and
comment rulemaking described in CGD.
– Once finalized,
finalized process for temporary and permanent
certification will supersede the CGD.
– Authorization process will constitute the new method for
“recognizing” certification bodies.
 Temporary Certification Program
National
NIST
Coordinator

Authorizess
A
Develops

Test ONC-Authorized
Methods Testing & Certification Bodies

Tests and Certifies

p
Complete EHRs/EHR Modules

Vendors/
Source: ONC - HIT Policy Committee Presentation Self-Developers 26
Overview of Temporary Certification Program
ONC-Authorized
h i d Testing
i andd Certification
ifi i Bodyd (ONC-
(
ATCB)
• An organization or organizations
• Submit an application to National Coordinator to demonstrate
competency to test and certify Complete EHRs and/or EHR
Modules
• Under temporary certification program, an applicant for ONC-
ATCB must be able to test and certify Complete EHRs and/or
EHR Modules
d l
• Anticipated that only a few organizations would qualify
• Program will sunset once permanent certification is established
and at least one certification body has been authorized by the
National Coordinator
Overview of Permanent Certification Program

Permanent Program
g
• ONC-Approved Accreditor (ONC-AA)
• ONC-Authorized
ONC Authorized Certification Body (ONC-
(ONC
ACB)
• National
N ti l Voluntary
V l t Laboratory
L b t
Accreditation Program (NVLAP)
Overview of Permanent Certification Program

• Introduces ONC-Approved Accreditor (ONC-AA)

– Will ffulfill
lfill responsibilities
ibiliti assumedd by
b the
th National
N ti l
Coordinator under the temporary certification program
– Nat
National
o a CooCoordinator,
d ato , where
w e e appropriate,
app op ate, will
w seek
see to
move as many of the temporary certifications
program’s processes as possible to organizations in the
private sector.
sector
– Only one at a time
Overview of Permanent Certification Program
ONC – Authorized Certification Body (ONC-ACB)
• ONC-ACB in the permanent certification program is different than an
ONC ATCB iin th
ONC-ATCB the ttemporary certification
tifi ti program.
• Under permanent certification program, National Coordinator’s
authorization would be valid only for certification.
• National Coordinator’s authorization would no longer be valid for the
purposes of testing Complete EHRs and EHR Modules.
• Proposed that NIST through the National Voluntary Laboratory
Accreditation Program (NVLAP) would be responsible for accrediting
testing laboratories and determining their competency
• NIST would be solely responsible for overseeing activities related to
testing laboratories
 Permanent Certification Program
[Testing] [Certification]
National
NIST
Coordinator
NVLAP
Approves

Authorizes
A
Accreditss

ONC-AA

A
Accredits
dit

NVLAP-Accredited ONC-Authorized
Testing Laboratories Certification Bodies

Tests Certifies
Complete EHRs/ Complete EHRs/
EHR Modules EHR Modules
Source: ONC - HIT Policy Committee
Vendors/
Presentation Self-Developers 31
 Health IT Provisions
in Healthcare Insurance Reform Law
 Health IT Provisions in Healthcare
Insurance Reform Legislation
1. On May 23, 2010, President Obama signed into law HR
3590 the Patient Protection and Affordable Health Care
3590,
Act.
2. The U.S. Senate passed H.R. 3590 on December 24,
2009 and the U.S.
2009, U S House of Representatives passed it on
March 21, 2010.
3. Also on the March 21, 2010, the House passed the
Reconciliation Act of 2010, HR 4872, which makes
changes to HR 3590. The Senate is expected to consider
HR 4872 during the week of March 22, 2010.

33
 Health IT Provisions in Healthcare
Insurance Reform Legislation
HR 3590 aims to increase healthcare coverage among
Americans and implement broad reforms within the
Insurance industry
• Aims
Ai tto expand d hhealth
lth insurance
i coverage to
t 32
million currently uninsured Americans
• Prohibits insurance companies from denying coverage
to individuals with preexisting conditions (effective
immediately for children and applies to all individuals
beginning in 2014)
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 Health IT Provisions in Healthcare
Insurance Reform Legislation Cont.
Cont

•EExpands d Medicaid
M di id to
t cover individuals
i di id l with ith income
i
less than 133 percent of the federal poverty level, or
$29,327 for a family of four
• Closes the gap in prescription drug coverage
• Prohibits insurance companies from placing lifetime
caps on coverage
• Requires health plans to allow young adults, up to age
26,, to remain on their pparents’ insurance ppolicyy
 Health IT Provisions in Healthcare
Reform Legislation
Leverages health IT to improve the quality, cost, and
access to healthcare
• Supports programs to foster the reporting of quality measures
through the use of health IT
• Di t th
Directs the establishment
t bli h t off standards
t d d to t facilitate
f ilit t the
th
enrollment of individuals in health plans, as well as standards
to enable the determination of an individual’s eligibility and
fi
financial
i l responsibility
ibili for
f specificifi services
i prior
i to or at the
h
point of care
• Establishes new programs that apply, among many things,
health IT to test new, more effective healthcare delivery
36
models
 Health IT Provisions in Healthcare
Insurance Reform Legislation
Leverages health IT to improve the quality, cost,
and access to healthcare (cont.)
(cont )
• Aims to increase the use of health IT in long-term care
settings
g through
g financial assistance
• Directs the use of health IT in health risk assessments for
Medicare beneficiaries
• E bli h incentive
Establishes i i payments forf health
h l h plans
l andd providers
id
that apply health IT in improving healthcare outcomes
• Supports health IT education and training among medical
students
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Other Issues of Interest
 FDA and EHRs as Medical Devices
• Per FDA, health IT has advanced so far that the professional
intermediary is no longer required or used
• “Under the Federal Food,, Drug, g, and Cosmetic Act,, health IT
software is a medical device.”
• Per voluntary reports from patients, clinicians, and user
facilities, the FDA cites data indicatingg 260 reports
p of HIT-
related adverse events, including 44 reported injuries and 6
reported deaths
• “Because these reports were purely voluntary, they may
represent onlyl the
h tip
i off the
h iceberg
i b in
i terms off HIT
problems that may exist”
• FDA UNDECIDED AT THIS TIME!
- Testimony of Dr. Jeffery Shuren, Director for FDA Center for Devices and Radiological Health to the HIT Policy Committee 2/25/10
 3 FDA Options for Engagement

– Option 1: Focus on Postmarket Safety

– Option 2: Focus on Quality Manufacturing and

Postmarket Safety

– Option 3: Traditional FDA Regulatory Framework

 Additional Information

For additional information related to ARRA, please access the

HIMSS website:
http://www.himss.org/EconomicStimulus/

Comments on Meaningful Use

http://www.himss.org/content/files/HIMSSResponseCMS_
MU%20NPRM.pdf
Standards and Certification Criteria
http://www.himss.org/content/files/HIMSSresponseONC_IF
R df
R.pdf
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 Health IT Provisions in Healthcare
Insurance Reform Legislation
Additional information concerning health IT provisions
included in healthcare reform legislation can be accessed
through the HIMSS website:

http://www.himss.org/ASP/topics_healthcarereform.asp

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