Transcript PPT

Health IT Regulatory Update
Pathology Informatics Summit 2016
May 25, 2016
Pittsburgh, PA
Walter H. Henricks, M.D.
Cleveland Clinic
Notice of Faculty Disclosure
In accordance with ACCME guidelines, any individual in a position to influence and/or
control the content of this ASCP CME activity has disclosed all relevant financial
relationships within the past 12 months with commercial interests that provide products
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The individual below has responded that he/she has no relevant financial relationship(s)
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Walter Henricks, MD
Agenda
• Significant recent developments of Meaningful
Use programs and EHR Standards and
Certification Criteria
• Status of ONC’s LIS-EHR Implementation
Guides (LRI, LOI, eDOS)
• MACRA, MIPS – and relevance to health IT
Walter H. Henricks, M.D.
• “The meaningful use program as it
has existed will now be effectively
over and replaced with something
better”
CMS Acting Administrator Andy Slavitt,
at the J.P. Morgan Annual Health Care
Conference, Jan. 11, 2016
Walter H. Henricks, M.D.
Meaningful Use “on Death Watch”?
Jan. 13, 2016
Walter H. Henricks, M.D.
Not so Fast, My Friend…
Jan. 15, 20016
Walter H. Henricks, M.D.
What’s going on??
Walter H. Henricks, M.D.
Jan. 19, 2016
What I meant to say…
https://www.healthit.gov/
buzz-blog/meaningfuluse/8791/
Walter H. Henricks, M.D.
“What I meant to say…”
• “…MACRA also continues to require that
physicians be measured on their meaningful
use of certified EHR technology for purposes
of determining their Medicare payments…”
• “We encourage you to look for the MACRA
regulations this year; in the meantime, our
existing regulations – including meaningful
use Stage 3 – are still in effect.”
https://blog.cms.gov/2016/01/
Walter H. Henricks, M.D.
ARRA
(American Recovery and Reinvestment Act)
includes
HITECH
(Health Information Technology for Economic and Clinical Health Act)
implemented in
CMS Rule
alignment
- EHR Incentive Program
(“Meaningful Use”; MU)
- HOW providers and
hospitals must use EHRs
ONC Rule
- EHR Standards and
Certification Criteria
(SCC)
- WHAT EHRs must be
able to do
(ONC = Office of the National Coordinator for
Health Information Technology in HHS)
Walter H. Henricks, M.D.
Brief Regulatory History of EHRs
• July 2010: Stage 1 MU; 2011 Edition SCC
• Sept. 2012: Stage 2 MU; 2014 Edition SCC
• Sept. 2014: CEHRT Flexibility Rule
– Allowed for delays in EHRs meeting 2014 Edition
• Sept. 2014: 2014 Edition SCC Release 2
– Added flexibility; focused on interoperability; set
stage for 2015 Edition SCC
• March 2015: Proposed Rules: Stage 3 MU and
2015 Edition SCC
MU=Meaningful Use; SCC=Standards and Certification Criteria
CEHRT=Certified Electronic Health Record Technology
Walter H. Henricks, M.D.
October 2015 – Final Rules: Stage 3
MU; 2015 Edition SCC
https://www.gpo.gov/fdsys/pkg/FR-2015-10-16/pdf/2015-25595.pdf
https://www.gpo.gov/fdsys/pkg/FR-2015-10-16/pdf/2015-25597.pdf
Walter H. Henricks, M.D.
Walter H. Henricks, M.D.
https://breaktheredtape.org/ehr-design-mismatch
Walter H. Henricks, M.D.
https://breaktheredtape.org/ehr-design-mismatch
Walter H. Henricks, M.D.
N Engl J Med 373;17
Walter H. Henricks, M.D.
“In recognition of these concerns…”
MU3 Final Regulations:
• Make significant changes to current
requirements
• Ease reporting burden for providers
• Encourage application for exemptions
• Enable individuals easier access to their
information
• Allow providers to choose measures most
meaningful to their practices
• Postpone deadline to Jan. 1, 2018
Walter H. Henricks, M.D.
Breaking up stage 3
• CMS restructured MU objectives and
measures for 2015 through 2017 to align with
Stage 3, and modified Stage 2 objectives
• Stage 3 requirements are optional in 2017
• All providers required to comply with Stage 3
beginning in 2018 using EHR technology
certified to the 2015 Edition
Walter H. Henricks, M.D.
MU Major Provisions 2015-2017
• Eligible professionals (EPs): 10 objectives
– Down from 18
• Eligible and critical access hospitals (CAHs):
9 objectives
– Down from 20
• Clinical Quality Measures (CQM): EPs-9;
EH/CAH-16
– No change
Walter H. Henricks, M.D.
MU Objectives and Measures 2016
• Protect electronic protected health information
in CEHRT
• Clinical decision support
• Computerized provider order entry (CPOE) for
meds, lab, and radiology orders
• E-Prescribing for medications (eRx)
• Health information exchange – transitions of
care; summary care record
• Patient-specific education resources to
patients
Walter H. Henricks, M.D.
MU Objectives and Measures 2016
(cont’d)
• Medication reconciliation
• Patient electronic access – view online,
download, and transmit (VDT) their health
information
– EPs within 4 business days
– Hospitals within 36 hours of discharge
• Secure electronic messaging with patients (EPs)
• Public health reporting – including reportable
results (Hospitals)
Walter H. Henricks, M.D.
MU Stage 3 2018-beyond
• 8 objectives for eligible professionals, eligible
hospitals, and CAHs
• Public health reporting with flexible options
• CQM reporting aligned with CMS quality
reporting programs
• Finalize use application program interfaces
(APIs) that enable development of new
functionalities
• Stage 3 requirements subject to change(?)
– Final rule issued with public comment period
Walter H. Henricks, M.D.
MU by stage and year
https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/index.html
MU Stage 3 (& Modified Stage 2)
Changes For Labs
• GONE: 55% of laboratory results
incorporated into EHR as structured data
• GONE: Eligible hospitals send (directly or
indirectly) structured electronic laboratory
results to ambulatory ordering providers for
more than 20% of electronic laboratory orders
received
Walter H. Henricks, M.D.
MU Stage 3 (& Modified Stage 2)
Relevant to Labs
• NEW: >5% patients VDT their records on line
– one patient in 2016; >5% 2017; >10% 2018– 36 hours after discharge
– 4 days after EP visit or results available
• Laboratory test report(s) in VDT must conform
to CLIA, including reference ranges and
corrected reports
VDT= view, download, transmit
Walter H. Henricks, M.D.
ONC 2015 Edition Marks Significant Shift
• “EHR”, “EHR Technology”  Health IT
• “EHR Module”  Health IT Module
• “The term health IT is reflective of the scope of
ONC’s authority…and represents a broad range
of technology...”
• “Our proposals…would permit other types of
health IT (e.g., laboratory information
systems (LISs)), …to receive appropriate
attribution and not be referenced by a certificate
with ‘EHR’ in it.” (from proposed rule, March 2015)
Walter H. Henricks, M.D.
ONC 2015 Edition SCC
• Less 1:1 linkage of EHR criteria to MU
objectives
• “Base EHR” Definition
• Common MU Data Set - key health data that
should be accessible and available for
exchange
Walter H. Henricks, M.D.
NOT Included in 2015 Edition SCC
• Criteria from previous editions and NPRM:
– Incorporate Laboratory Tests and Values/Results
– Transmission of Laboratory Test Reports
• CLIA requirements for test requisition
information (42 CFR 493.1241)
• ONC’s EHR-LIS Interface Implementation
Guides (IGs)
– LRI
– LOI
– eDOS
Walter H. Henricks, M.D.
Status of ONC’s LIS-EHR
Implementation Guides
(LRI, LOI, eDOS)
Walter H. Henricks, M.D.
Laboratory Results Initiative (LRI) and
Laboratory Orders Initiative (LOI)
Implementation Guides (IGs)
• Requirements, specifications, standards, and
implementation guidance for electronic
reporting of laboratory test results and for
electronic ordering of laboratory tests in
ambulatory care settings
• Use Cases directed at reporting between LIS
and EHR
• Developed through ONC S&I Framework and
balloted and approved through HL7
Walter H. Henricks, M.D.
LRI Context Diagram
Walter H. Henricks, M.D.
LOI Context Diagram
Walter H. Henricks, M.D.
Laboratory Test Compendium Framework
(eDOS) Implementation Guide (IG)
• Standardized means of electronically communicating
a laboratory’s Directory of Services (eDOS)
• Defined format to deliver laboratory test menu
offerings and related information to systems that
support electronic laboratory ordering, results
reporting, and other functionality
• Support of initial eDOS build for each new client and
ongoing maintenance updates
• Laboratory = Compendium Producer
• EHR (or other system) = Compendium Consumer
Walter H. Henricks, M.D.
eDOS Context Diagram
Walter H. Henricks, M.D.
What is the Relevance of the LOI, LRI, eDOS
Implementation Guides to Laboratories?
• They will dictate what the future looks like for
laboratory information exchange and LIS
interfaces.
• They are woven into the fabric of ONC’s
emerging, broader framework of “Health IT”,
which will encompass LISs and other aspects
of laboratory information use.
• Laboratories will need to ensure that their
systems and interfaces are compliant.
• The IGs will continue to evolve and expand.
Walter H. Henricks, M.D.
ONC Labs US Realm Pilot Project
• Opportunity for field testing
• CAP partnering with ONC
http://wiki.siframework.org/Lab+US+Realm+Pilot+Project
Walter H. Henricks, M.D.
MACRA, MIPS
and their relevance to health IT
Walter H. Henricks, M.D.
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-BasedPrograms/MACRA-MIPS-and-APMs/MACRA-LAN-PPT.pdf
50%
10%
15%
25%
100%
Summary
• Major changes have occurred recently in the
Meaningful Use and EHR Standards and
Certification Criteria
• Implementation Guides for LIS-EHR
interfaces have been dropped from Final Rule
• MACRA and MIPS establish future payment
structures that include meaningful use of
certified EHR technology
Walter H. Henricks, M.D.