HITECH, ICD-10, LOINC, ACOs,
and Integrated Diagnostics:
The Impact of Change in Healthcare
on the Laboratory
The healthcare arena is in a state of uncertainty and undergoing an immense amount of change. HITECH, Meaningful Use, Accountable Care Act, Accountable Care Organizations (ACO), Patient-Centered Medical Home (PCMH), ICD-10, LOINC, integrated diagnostics, and personalized medicine are converging and are the various market factors driving change. The laboratory is in the midst of this change and will be impacted.
In an effort to inform, warn, and motivate, Curt Johnson, COO at Orchard Software, gave this presentation to attendees at the 2012 ASCLS/AACC annual convention in Los Angeles. Curt touches briefly on the numerous topics listed above and explains how laboratories will be impacted and what they can do to position themselves for being an important player in the new healthcare landscape. View the presentation slides and audio per the instructions below:
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In February of 2009, a $787 billion dollar economic stimulus package called the American Recovery and Reinvestment Act (ARRA) became law. Included in the ARRA package is a $19.2 billion dollar allocation of funds to the Health Information Technology for Economic and Clinical Health (HITECH) Act that incentivizes physicians and hospitals to successfully adopt certified EMR/EHR technology and demonstrate "meaningful use" of that system. HITECH also provides funds for the Office of the National Coordinator for Health Information Technology (ONCHIT) that oversees Health Information Technology (HIT) standards, implementation, and impact assessment. ONCHIT, a division of the Department of Health and Human Services (HHS), has the responsibility of setting goals for developing a nationwide HIT network that optimizes electronic exchange of health information. The ONC is responsible for setting standards, implementation specifications, and certification criteria for EHR technology, while CMS (Centers for Medicare and Medicaid Services) determines the specific criteria that providers and hospitals must adhere to in order to demonstrate "Meaningful Use" (MU) of their EMR/EHR and thus qualify for MU financial incentives.
Financial incentives are being offered to both physicians and hospitals. The total incentive that each physician can earn over time is $44,000. Eligible participants must begin reporting by October 1, 2012 in order to be eligible for the full $44,000 incentive. The incentive for hospitals is determined by a more complex equation, but for most hospitals, it will be over $2 million. These incentives are earned and paid out over a five- to six-year period of time, depending on the use of a certified EMR/EHR and meeting meaningful use criteria. After 2015, the government is proposing a penalty of a reduction in Medicare reimbursements for those physicians and hospitals who do not comply with these EMR/EHR initiatives. For more specifics regarding incentives, download the PDF of the slides from the ARRA webinar and review slides 8-16, or go to www.cms.gov/EHRIncentivePrograms/, on the CMS website.
Use of Certified EHR Technology (CEHRT) is a core requirement for providers and hospitals who seek to qualify to receive incentive payments authorized in the ARRA/HITECH Act. Certification assures healthcare providers and hospitals that the EMR/EHR technology they adopt has been tested and includes the required capabilities they need in order to use the technology in a meaningful way to improve the quality of care provided to their patients.
In the summer of 2010, the ONC began accepting applications from entities and organizations interested in becoming ONC-ATCB (Authorized Testing and Certifying Bodies). As of this writing, the following six organizations have been selected as ONC-Authorized Testing and Certification Bodies (ATCBs):
- Certification Commission for Health Information Technology (CCHIT) - Chicago, IL
- Drummond Group Inc. (DGI) - Austin, TX
- ICSA Labs - Mechanicsburg, PA
- InfoGard Laboratories, Inc. - San Luis Obispo, CA
- SLI Global Solutions - Denver, CO
- Surescripts LLC - Arlington, VA (Pharmacy only)
Please note that while CCHIT is one of the ATCBs, EMR/EHRs certified by CCHIT prior to this announcement will need to reapply for certification under ONC-ATCB.
Will my existing EMR/EHR qualify? The answer is yes, as long as your EMR/EHR vendor applies for and obtains certification from one of the ONC-ATCBs. We recommend that you check with your existing EMR/EHR vendor to determine their plans for certification. Some EMR/EHR vendors are not applying for certification on earlier versions of their software, and an upgrade by your organization may be necessary to qualify for incentives.
The ONC has begun listing certified EMR/EHRs on their website. Visit http://healthit.gov for that listing. For more specifics regarding EMR/EHR certification, download the PDF of the slides from the ARRA webinar and review slides 17-23, visit http://healthit.gov/certification, or read the PDF of the certification criteria for EHR technology from the Federal Register.
The answer is, "It depends." On the ONC’s Regulations FAQs, Question [9-10-010-1], it states that "Other IT systems that act as data sources and are not intended to perform required capabilities in accordance with adopted certification criteria do not need to be certified simply because they supply data to a Complete EHR or EHR Module."
However, if your LIS is performing any of the functions necessary to meet meaningful use criteria, acting as an "EHR Module," then the answer is "Yes, your LIS will need to be certified." Examples of meaningful use criteria that might be performed by the LIS instead of through the EMR/EHR are physician order entry and electronic lab reporting.
If you are using an EMR Module to perform a task necessary for proving meaningful use, then that module must be certified. Because our systems are being used for some of the necessary criteria, such as Computerized Physician Order Entry (CPOE), sending surveillance data, and Electronic Lab Reporting (ELR), Orchard Software has obtained its Eligible Provider certification for v8.5 read press release 8.5 and v9.0 read press release 9.0 and is in the process of obtaining our Eligible Hospital certification for Orchard Harvest LIS. For more information regarding this certification visit our blog, colLABorate.
Meaningful Use objectives will continue to evolve in the following three stages:
|Stage 1||Stage 2||Stage 3|
|Data capture and sharing||Advanced clinical processes||Improved outcomes|
Stage 1 Requirements
In July of 2010, CMS issued final Stage 1 requirements for meaningful use. The final rule on Stage 1 MU has also been published in the Federal Register. To qualify for these financial incentives and avoid penalty, physicians and hospitals need to adopt certified EMR/EHR technology, achieve MU objectives, and then apply for the incentive payment.
Stage 1 MU criteria established 15 Core Objectives for providers and 14 for hospitals. You must select five out of ten objectives from a Menu of Objectives, of which one must be a public health objective. In addition to that, there are six total Clinical Quality Measures required, of which three must be from core measures (or alternate core measures) and an additional three chosen out of a menu of 38 measures.
- 15 Core Objectives (14 for hospitals)
- 5 out of 10 Objectives from a Menu of Objectives
- 6 total Clinical Quality Measures
- 3 from Core Measures (or alternate core measures)
- 3 out of 38 Measures from a Menu
For more specifics regarding Stage 1 meaningful use criteria, download the PDF of the slides from the ARRA webinar and review slides 24-40. You may also visit www.cms.gov/EHRIncentivePrograms/, which features information about who is eligible for the programs, how to register, meaningful use, upcoming EHR training and events, and other information. Or, read the PDF of the meaningful use criteria for EHR users from the Federal Register.
Stage 2 Requirements
In August of 2012, CMS issued final Stage 2 requirements for meaningful use. The new criteria detail exactly what Eligible Professionals (EPs), Eligible Hospitals (EHs), and Critical Access Hospitals (CAHs) will need to do in order to continue to receive payments from the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program.
Stage 2 MU criteria include 17 core objectives for providers and 16 for hospitals. EPs as well as EHs/CAHs must select three out of six objectives from a Menu of Objectives. Clinical Quality Measure (CQM) reporting has been removed as a core objective but providers are still required to report in order to demonstrate meaningful use. For 2013, providers will continue to report six from the 44 measures from Stage 1: three from the core or alternate core measures and three additional measures from the remaining list of 38.
Beginning in 2014, EPs must report on 9 out of 64 CQMs and EHs/CAHs must report on 16 out of 29 total CQMs. In addition, all providers must select CQMs from three of the six Health & Human Services (HHS) National Quality Strategy (NQS) Domains:
- Patient and Family Engagement
- Patient Safer
- Care coordination
- Population and Public Health
- Efficient Use of Healthcare Resources
- Clinical Processes/Effectiveness
Recommended core CQMs are 9 for adult populations and 9 for pediatric population. The complete list of 2014 CQMs is not available yet, but will be posted on the CMS EHR Incentive website in the future. For more information on CQMs, download the 2014 Clinical Quality Measures Tip Sheet.
- For EPs: 17 Core Objectives, Plus 3 out of 6 Menu Objectives
- For EH & CAHs: 16 Core Objectives, Plus 3 out of 6 Menu Objectives
- 6 (2013) Total Clinical Quality Measures (9 starting in 2014)
- 3 from Core Measures (or Alternate Core Measures)
- 3 out of 38 Measures from Menu
What’s coming for Stage 3 Meaningful Use?
It is expected that by Stage 3, ALL of the menu items will become core objectives for MU. For EHs/CAHs, in Stage 3 it is proposed that 15 clinical decision support (CDS) interventions be linked to five or more CQMs, which may include CDS for the appropriateness of lab and radiology orders in an attempt to avoid redundant or inappropriate ordering. Stage 3 is also expected to bring more patient engagement, such as the capability to upload results from home devices such as glucose monitors, blood pressure cuffs, and weight measurements. To read more on the proposed Stage 3 criteria go to http://healthit.gov/ or review the HIT Policy Committee: Meaningful Use Workgroup Stage 3 – Preliminary Recommendations Power Point from the heathit.gov website.
Below is a table showing the MU criteria for Stage 1 and 2 and proposed Stage 3 criteria that impact the lab.
|Stage 1 Final||Stage 2 Final||Proposed Stage 3|
|CPOE for (30%) of medication orders||CPOE (by licensed professional) for more than 60% of medication, 30% of lab, and 30% of radiology orders||CPOE (by licensed professional) for 60% medication, lab, and radiology orders AND 20% of referrals/transition of care orders|
|Incorporate lab results as structured data (40%)—Menu objective||
Incorporate lab results as structured data moved to a core objective and increased to 55%
Hospital MENU Objective:
Incorporate lab results as structured data increase to more than 80%
Hospital labs send (directly or indirectly) structured electronic clinical lab results to the ordering provider for more than 70% of electronic lab orders received.
Hospital Menu Objective:
Move to Hospital Core Objective:
EH Core Objective (unchanged):
When will Final MU Criteria Stage 3 be published? The MU workgroup made initial Stage 3 recommendations on August 1, 2012, so that a Request for Comment can be issued in November, final recommendations can be published by May 2013, and a final transmittal letter may be sent to HITPC in July 2013.
Integration and the ability to send structured data are the biggest issues facing laboratories regarding the ARRA and aiding their facility in meeting MU criteria. With CPOE and incorporating laboratory test results into a certified EHR as structured data becoming core objectives in Stage 2, it is even more imperative that laboratories are electronically integrated to the EMR and have the ability to send results in a structured format. Electronic integration for order entry and result delivery is no longer the future; it is now. The use of LOINC and SNOMED codes will also be mandatory in order to continue to receive MU incentive payments. These integration and portability issues will affect all labs, including POLs, hospitals, and reference laboratories. The ability to integrate your laboratory and send data to your facility’s EMR or your laboratory clients’ EMR system will be the number one issue facing all laboratories for the next couple of years.
We encourage you to stay abreast of these proposals and determine how they will impact you. We here at Orchard will do our best to keep you aware of the proposals and final rulings for “Meaningful Use” as they are announced. We are holding complimentary webinars to keep you informed and posting on this page recordings and PDFs of the slides for your review. Monitor our website regularly and check our colLABoration blog to stay abreast of this topic and of future webinar offerings. And, don’t hesitate to send us your ARRA questions surrounding the lab or your LIS via the buttons at the top and bottom of this page.
You can also use your favorite search engine to find many postings and white papers on the subject of meaningful use. Another good source will be your EMR vendor, as most EMR companies are very aware of this topic and have information on their websites.
We are experts in integration, and our systems are designed to generate, store, and share structured data. With over 1,200 laboratory customers—including physician offices, clinics, hospitals, independent reference labs, and university student health centers, Orchard has successfully interfaced our lab systems to hundreds of instruments, healthcare information systems, reference laboratories, public health centers, and EMRs. As a best-of-breed vendor, our products have been designed with electronic integration in mind. Click the link to learn more on how our lab systems and our Copia laboratory outreach and integration system aid you in EMR integration. To request more information and arrange to speak with one of our representatives about how Orchard can help your lab connect to your EMR or your clients' EMR, click the button below.