What Government Regulation Is Intended to Promote the Use of Ehrs
J Pathol Inform. 2011; ii: seven.
"Meaningful use" of electronic health records and its relevance to laboratories and pathologists
Walter H. Henricks
Eye for Pathology Informatics, Pathology and Laboratory Medicine Establish, L21, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, The states
Received 2010 Dec 8; Accepted 2010 Dec 31.
Abstract
Electronic health records (EHRs) take emerged as a major topic in wellness care and are central to the federal government's strategy for transforming healthcare commitment in the United States. Contempo federal actions that aim to promote the utilise of EHRs hope to have significant implications for laboratories and for pathology practices. Under the HITECH (Health Information Technology Economical and Clinical Health) Act, an EHR incentive program has been established through which private physicians and hospitals tin qualify to receive incentive payments if they achieve "meaningful use" of "certified" EHR technology. The rule also establishes payment penalties in futurity years for eligible providers who accept not met the requirements for meaningful apply of EHRs. Meaningful utilise must be accomplished using EHR technology that has been certified in accordance with functional and technical criteria that are prepare forth a regulation that parallels the meaningful use criteria in the incentive program. These deportment and regulations are important to laboratories and pathologists for a number of reasons. Several of the criteria and requirements in the meaningful use rules and EHR certification criteria relate direct or indirectly to laboratory testing and laboratory information management, and hereafter phase requirements are expected to impact the laboratory as well. Furthermore, every bit EHR uptake expands, at that place will be greater expectations for electronic interchange of laboratory information and laboratory information system (LIS)-EHR interfaces. Laboratories volition need to be enlightened of the technical, operational, and business organisation challenges that they may confront equally expectations for LIS-EHR increase. This paper reviews the important recent federal efforts aimed at accelerating EHR use, including the incentive program for EHR meaningful employ, provider eligibility, and EHR certification criteria, from a perspective of their relevance for laboratories and pathology practices.
Keywords: Electronic health records, federal regulations, laboratory information management, laboratory information systems, meaningful use
INTRODUCTION
Electronic wellness record (EHR) systems are at present a major topic in wellness intendance. Use of EHRs in physician practices and in healthcare organizations directly impacts the communication and management of laboratory data in patient care, particularly reporting of laboratory results and test order management. More than pointedly, recent federal legislation and resultant regulations that aim to promote the apply of EHRs promise to have substantial direct and indirect implications for laboratories and for pathology exercise.
EHRs are central to the goals that the federal regime has identified for improving healthcare:[1]
-
Better quality, rubber, and efficiency of healthcare and reduce health disparities.
-
Engage patients and families in their healthcare.
-
Better coordination of healthcare.
-
Improve population and public health.
-
Maintain privacy and security of wellness information.
-
Reduce costs.
A minority of the physicians and healthcare organizations accept fully implemented EHRs. Recent information from the CDC/National Center for Health Statistics betoken that 25% of the office-based physicians are using at to the lowest degree a "basic" EHR system, and merely 10% are using a fully functional EHR.[2] In the nigh recent Healthcare Information Management Systems Society (HIMSS) Leadership Survey,[three] 22% of the healthcare organizations reported in 2010 that they had a fully operational electronic medical record across their entire organization (up from 17% in 2009), although just 5% reported that they had not yet begun to plan for electronic medical record implementation.
In recent months, the federal government has enacted regulations and programs in lodge to accelerate the implementation of EHRs by healthcare providers and healthcare organizations. This paper reviews the important contempo federal efforts promoting EHR apply, including regulations on EHR meaningful use and EHR certification criteria, and explores their relevance for laboratories and pathology practices.
LEGISLATIVE AND REGULATORY BACKGROUND
The American Recovery and Reinvestment Human action of 2009 (ARRA), enacted in February 2009, included several provisions that in aggregate contain the Health Information Technology Economic and Clinical Health Human activity, or "HITECH Act." The HITECH Human activity includes a number of provisions aimed at improving healthcare quality, safety, and efficiency through promotion of health information technology (Striking), notably EHRs, and through greater electronic exchange of health data. There are other aspects of the HITECH Act as well, including modifications to the HIPAA regulations; these other provisions are out of the telescopic of this paper, and the reader is referred elsewhere.[4]
A master goal of the HITECH Act is to foster meaningful use of certified EHR technology. 2 recent, related major regulations have implemented the HITECH Act. Nigh significantly in this regard, the HITECH Human action called for establishment of an incentive payment plan for eligible professionals (eastward.m., physicians) and eligible hospitals that accomplish "meaningful use" of qualified EHRs and interoperable HIT. To define and to implement this incentive program, in July 2010, Centers for Medicare and Medicaid Services (CMS) issued a Final Rule entitled Medicare and Medicaid Programs; Electronic Wellness Record Incentive Program (42 CFR Parts 412, 413, 422, et al).[v] The HITECH Human action likewise required the Secretary of Health and Man Services (HHS) to adopt an initial gear up of standards, implementation specifications, and certification criteria for EHRs, along with establishing a certification program for EHRs. To meet these requirements, in July 2010, the Office of the National Coordinator for Health Data Technology (ONC) in the Department of Wellness and Human Services published a Concluding Dominion entitled Health It: Initial Set up of Standards, Implementation Specifications, and Certification Criteria for Electronic Wellness Tape Technology (45 CFR Office 170).[6] The relationships among ARRA, HITECH, and these two regulations are depicted in Figure ane.
Relationships among ARRA, HITECH, and Final Rules from CMS and ONC. (CMS, Centers for Medicare and Medicaid Services; ONC, Part of the National Coordinator for Health It.)
ONC is the primary agency in the federal government charged with developing and coordinating nationwide Striking policy and promoting the evolution of a nationwide health It infrastructure for use and substitution of electronic wellness information. The ONC resides in the Department of Health and Human Services. ONC was created past Executive Order in 2004, and the HITECH Deed made ONC permanent in law.
The two agencies in HHS, CMS and ONC, have worked together to coordinate the meaningful apply criteria and the EHR certification criteria where appropriate. In short, EHR certification criteria (ONC-defined) specified "what" an EHR arrangement must be able to do, while meaningful use criteria (CMS-defined) specified "how" a certified EHR system must exist used by an eligible provider or inside an eligible hospital environment to qualify for incentive payment and to avert future penalties. Meeting criteria for meaningful employ of EHR requires utilize of certified EHR technology.
MEANINGFUL Utilise OF EHRs
Overview
The EHR incentive plan establishes the criteria, reporting requirements, incentive payments, and (hereafter) penalties for eligible professionals and hospitals related to achieving the meaningful utilise of EHRs. Eligible professionals and eligible hospitals are those that participate in the Medicare or Medicaid programs. At that place are separate but related incentive programs for both Medicare and Medicaid-eligible providers and hospitals. Although there are some differences in some provisions of the administration of the Medicare and Medicaid programs, the meaningful employ criteria and required quality measures are largely common to both. The Medicaid program will be voluntarily offered by individual states.
"Meaningful use" has no simple definition, and is ultimately defined past the specific requirements laid out in the Final Dominion. The dominion embodies and implements the statutory requirements of the HITECH Act that specified 3 requirements for meaningful use:[1]
-
Use of certified EHR technology in a meaningful manner (e.thousand., e-prescribing).
-
Utilize of certified EHR engineering in a manner that provides for electronic exchange of wellness information to meliorate the quality of care.
-
Employ of certified EHR engineering to submit clinical quality measures (CQM) and other measures determined by the HHS Secretary.
CMS intends to implement meaningful utilize requirements in 3 stages. The current dominion describes Stage i requirements that are applicable to 2011 and 2012. CMS expects to update meaningful use criteria biannually, with Phase two criteria expected by the cease of 2011 and Phase iii criteria expected by the end of 2013. Stage ane focuses essentially on capturing and sharing electronic health information at fundamental levels and establishing capabilities for information exchange and reporting data to various agencies. In Stage 2, CMS has indicated that it will build on the requirements of Phase 1 with more rigorous expectations for health information exchange and for boosted EHR functionalities. In Stage three, CMS expects to focus on promoting and making improvements that pb to improved health outcomes both at the private and at the population levels, including greater apply of determination back up tools and patient access to self-direction tools.
Definitions, Eligibility, and Incentives/Penalties
The EHR incentive program Last Rule contains several intertwined definitions for different categories of EHR users. These definitions are fundamental to interpreting eligibility for incentives/penalties and the applicability of certain meaningful use requirements. The nigh relevant definitions of EHR users are:
Eligible Professional person (EP) (sections 495.four, 495.100, 495.304):
For the Medicare EHR incentive programme, EP generally includes the following types of professionals:
-
Doctor of medicine or osteopathy.
-
Medico of dental surgery or medicine.
-
Physician of podiatric medicine.
-
Dr. of optometry.
-
Chiropractor.
For the Medicaid EHR incentive program, EP mostly includes:
-
Physician.
-
Dentist.
-
Nurse/mid-married woman.
-
Practitioner.
-
Physician assistant in a federally qualified health eye (QHC) or rural health heart (RHC) that is so led by a medico assistant.
Hospital-based EP (495.4):
An EP (as defined under this department) who furnishes 90% or more than of his or her covered professional services in a infirmary setting in the year preceding the payment year.
Meaningful EHR user (495.4):
An EP (or) eligible infirmary that, for an EHR reporting period for a payment yr, demonstrates meaningful employ of certified EHR technology.
Qualifying EP (Medicare-applicative) (495.100):
An EP who is a meaningful EHR user for the EHR reporting menstruum for a payment twelvemonth and who is not a infirmary-based EP.
In the Medicare EHR incentive plan, EPs can receive up to $44,000 in incentives over five years, although to go the maximum incentive payment the EPs must start participation by 2012. Note that just qualifying EPs will receive payments; in accordance with the definitions, qualifying EPs are those that meet all the requirements for demonstrating meaningful use of certified EHR technology. Infirmary-based EPs are not eligible to receive incentive payments. The stated rationale for excluding hospital-based EP from incentives is that paying incentives to hospital-based EPs and eligible hospitals would represent double payment, in that infirmary-based EPs would be using the EHRs of the eligible hospitals. Under the Medicaid EHR incentive programme, EPs can receive up to $63,750 over 6 years. Incentive payments for eligible hospitals are based on a number of factors, which include the number of acute care inpatient discharges and the number of inpatient bed-days. For both programs, eligible hospital incentive payments brainstorm with a $2,000,000 base of operations payment and may go up from there.
Beginning in 2015 and standing in subsequent years, in the Medicare EHR Incentive Program, EPs who have not demonstrated meaningful use of certified EHR applied science will receive reduced payments for professional services (495.102(d)). For 2015, the penalty will exist a 1% reduction in the Medicare doctor fee schedule amount for professional services, and this increases to 2% in 2016 and to 3% for 2017 and each subsequent year. Hospital-based EPs are non discipline to the fee schedule reduction penalties that first in 2015. No payment reductions are included in the Medicaid EHR incentive program.
Every bit described to a higher place, hospital-based EPs are non eligible for EHR meaningful apply incentive payments and are not subject to downward payment adjustment penalties for not being meaningful users of EHRs. The definition and ways of determining a "Hospital-based EP" are clarified in the Provisions of the Proposed Rule and Analysis of and Responses to Public Comment in pages 44439–44442 of the CMS Last Rule. CMS defines a hospital-based EP as an EP who furnishes xc% or more of his/her covered professional services in a hospital setting in the year preceding the payment yr. A setting is considered a hospital setting if it is a site of service that would exist identified by the codes used in the HIPAA Standard Transaction as a infirmary inpatient or emergency room setting. Specifically in the Final Rule, CMS indicates that it will use but two place of service (POS) codes used on physician claims to make up one's mind whether an EP is a hospital-based EP: POS 21 (Inpatient Hospital) or POS 23 (Emergency Room, Hospital). From the rule:
"An EP will be defined as being infirmary-based and therefore ineligible to receive an EHR incentive payment nether either Medicare or Medicaid, regardless of the blazon of service provided, if more than 90 percent of their services are identified every bit being provided in places of service classified under two place of service codes 21 (Inpatient Hospital) or 23 Emergency Room, Hospital."
Are Pathologists Subject to Future Meaningful Use Penalties?
The definition of hospital-based EP in the Final Rule raises questions and concerns as to whether pathologists are eligible for incentives and, more chiefly, subject to penalties for non being meaningful users of EHR. The Cadre Measures and CQM that are required to become a Meaningful User of Certified EHR engineering science (run into later department) are largely either not applicable to or out of the scope of the practice of pathology. Furthermore, pathologists (generally) do non see and treat patients in an office setting and, therefore, the utilize of certified EHR technology in the comprehensive mode prescribed by CMS is not relevant to the pathologists.
Any eligible provider who is non either a qualifying EP (i.e., meaningful user of an EHR) or a hospital-based EP will be subject to Medicare payment reductions starting in 2015. Part of the issue stems from the fact that the definition of "infirmary-based" is rooted in the constabulary and a subsequent amendment of the HITECH Human activity. The CMS Concluding Rule explains (italics added):
"Sections 4101(a) and 4201(a) of the HITECH Human activity originally defined the term 'infirmary-based eligible professional' to hateful an EP, such as a pathologist, anesthesiologist, or emergency doc, who furnishes substantially all of his or her Medicare-covered professional services during the relevant EHR reporting period in a hospital setting (whether inpatient or outpatient) through the use of the facilities and equipment of the hospital, including the hospital's qualified EHRs."
In Apr 2010, however, afterwards the publication of the incentive plan Interim Final Rule that was available for public comment, an subpoena to the HITECH Deed was signed into law that inverse the statutory definition of a infirmary-based EP. This subpoena changed the central wording in the definition from "…in a infirmary setting (whether inpatient or outpatient)…" to "in a infirmary inpatient or emergency room setting".
The removal of "outpatient" is crucial to the relevance of the new definition of hospital-based EP to pathologists because, typically, greater than x% of the services (medico claims) that pathologists provide, even pathologists in hospital settings, are for outpatients. Based on the new definition of infirmary-based EP, the method for determining whether an EP is infirmary-based is based "solely" on the POS codes, on physician claims beingness POS 21 (Inpatient Hospital) or POS 23 (Emergency Room, Infirmary).
Pathologists' concerns about being discipline to payment penalties because the requirements for Cadre Measures and CQM are exterior the telescopic of pathology practice were addressed straight in the Final Rule. In brief, CMS indicated that the definition of infirmary-based EP is based in constabulary and that the Secretarial assistant (of HHS) has no discretion to exempt pathologists from the definition in the law (p.44443):
"An organization representing pathologists expressed concern that the Medicare EP definition, equally currently drafted would field of study certain pathologists to payment incentive penalties for not existence meaningful EHR users if the pathologists performed less than 90 pct of their professional services in any inpatient or outpatient setting in the prior yr. All EPs have to report on all Core Measures and a subset of clinical measures that pathologists could non meet in their solar day-to-day exercise given the nature of pathology's scope of exercise. Accordingly, this organisation recommended that CMS ensure that pathologists who are currently defined as Medicare EPs be considered every bit 'non-qualifying' EPs, that are exempt from future meaningful user penalties.
Response (from CMS; italics added): While we capeesh the comments that we received on the Medicare EP definition, we are unable to aggrandize or alter this statutory definition or consolidate it with the Medicaid programme EP definition equally suggested by the commenters. Nether the EHR incentive payment program, the constabulary provided a dissever Medicare EP definition rather than giving the Secretary authority or discretion to determine who is a Medicare EP or, who is an EP for both the Medicare and Medicaid programs."
The legal definition of infirmary-based EP and the style in which it will exist determined appear to betoken that pathologists for whom less than 90% of professional person services fall under POS codes for infirmary inpatient (POS 21) or emergency room (POS 23) will not meet the definition of hospital-based EP that would exempt them from future meaningful use penalties. While farther clarification would be welcome, pathology practices should be aware of these problems and should assess their situations in light of the combination of the eligibility considerations and definitions described to a higher place and the lack of applicability of EHR meaningful use requirements to general pathology do.
MEANINGFUL Employ REQUIREMENTS
The CMS Final Dominion on the EHR incentive program lays out the requirements for eligible professionals and eligible hospitals to come across the definition of meaningful use of certified EHR technology. The requirements are a combination of required cadre objectives, objectives selected from a card set, and reporting of CQMs in a manner specified by the HHS Secretarial assistant.
Eligible professionals must see:
-
fifteen core objectives.
-
Five objectives out of a menu set up of 10.
-
Reporting requirements for six CQMs.
-
Three core or alternating core CQMs and three of 38 from an additional ready of CQMs.
Hospitals must run into:
-
14 core objectives.
-
Five objectives out of a menu set up of 10.
-
Reporting requirements for xv CQMs.
The core objectives for eligible providers are listed in Table i and for eligible hospitals in Table 2. The menu set objectives for eligible providers are listed in Table 3 and for eligible hospitals in Table 4. Many of the Stage ane objectives will have compliance assessed by obtaining a sure pct measure out. For case, to meet certain objectives, lxxx% of patients must have records in certified EHR technology. Other objectives are related to the presence or absence of certain functions such equally implementation of at to the lowest degree one clinical conclusion support rule.
Table 1
Core objectives for meaningful utilise of EHRs: Eligible professionals
-
Computerized provider order entry (CPOE)
-
E-prescribing (eRx)
-
Report ambulatory Clinical Quality Measures to CMS/States
-
Implement one clinical decision support dominion
-
Provide patients with an electronic copy of their health information, upon request**
-
Provide clinical summaries for patients for each role visit
-
Drug–drug and drug–allergy interaction checks
-
Record demographics
-
Maintain an upwards to date trouble list of current and active diagnoses
-
Maintain active medication list
-
Maintain active medication allergy list
-
Record and chart changes in vital signs
-
Record smoking status for patients 13 years or older
-
Capability to exchange key clinical information among providers of intendance and patient-authorized entities electronically**
-
Protect electronic health information
Table 2
Cadre objectives for meaningful use of EHRs: Hospitals
-
Computerized provider lodge entry (CPOE)
-
Drug–drug and drug–allergy interaction checks
-
Tape demographics
-
Implement one clinical decision support dominion
-
Maintain upward-to-date problem list of current and agile diagnoses
-
Maintain active medication list
-
Maintain active medication allergy list
-
Record and chart changes in vital signs
-
Tape smoking status for patients 13 years or older
-
Report hospital Clinical Quality Measures to CMS or States
-
Provide patients with an electronic copy of their wellness information, upon request**
-
Provide patients with an electronic copy of their belch instructions at time of belch, upon asking
-
Capability to exchange key clinical data among providers of care and patient-authorized entities electronically**
-
Protect electronic health information
Table 3
Menu objectives for meaningful employ of EHRs: Eligible professionals***
-
Drug-formulary checks
-
Comprise clinical lab test results every bit structured information**
-
Generate lists of patients by specific weather condition
-
Transport reminders to patients per patient preference for preventive/follow-upward intendance
-
Provide patients with timely electronic access to their wellness information**
-
Use certified EHR technology to identify patient-specific pedagogy resources and provide to patient, if appropriate
-
Medication reconciliation
-
Summary of care record for each transition of intendance/referrals
-
Capability to submit electronic information to immunization registries/systems*
-
Capability to provide electronic syndromic surveillance information to public health agencies*
Table 4
Menu objectives for meaningful use of EHRs: Hospitals***
-
Drug-formulary checks
-
Record advanced directives for patients 65 years or older
-
Incorporate clinical lab test results every bit structured data**
-
Generate lists of patients by specific atmospheric condition
-
Use certified EHR engineering science to identify patient-specific education resources and provide to patient, if advisable
-
Medication reconciliation
-
Summary of care record for each transition of care/ referrals
-
Capability to submit electronic data to immunization registries/systems*
-
Capability to provide electronic submission of reportable lab results to public health agencies*
-
Capability to provide electronic syndromic surveillance data to public health agencies*
CQMs are assessments and measures of healthcare quality that have been adult and endorsed by CMS in collaboration with other healthcare quality agencies such as the National Quality Forum (NQF), the Bureau for Healthcare Inquiry and Quality (AHRQ), and others. With respect to reporting CQMs to CMS (or to the State in the case of the Medicaid programme), the Final Rule indicates that CQMs are to be reported in the fashion specified past CMS. CMS specifies the CQMs for eligible professionals in Table 6 of its final rule, and specifies core and alternate core measures in Table seven of its final rule. CQMs for hospitals are listed in Table 10 of the final rule. The CQMs are summarized here in Tables 5 and six. Eligible professionals must written report on a total of 6 CQM, of which iii must be from a divers core set of 3 CQMs or from a gear up of upward to three alternate cadre CQMs if one or more than cadre set CQM(s) is not applicable to a given eligible professional person's practice setting. In addition, eligible providers must study on three CQMs out of a menu of 38 options [Tabular array 5]. Overall, eligible professionals must report on a total of six CQMs – three core or alternate core measures and three additional measures. Hospitals must report on 15 quality measures [Table half dozen].
Table 5
Core Set up CQMs (must complete three core or alternate core)
|
| Alternate cadre set CQMs |
|
| Boosted set CQM (must complete three of 38) |
|
Table 6
CQMs for meaningful use of EHRs: Hospitals (must consummate all xv)
-
Emergency department throughput – admitted patients median fourth dimension from ED arrival to ED difference for admitted patients
-
Emergency department throughput – admitted patients –admission conclusion fourth dimension to ED deviation time for admitted patients
-
Ischemic stroke – discharge on antithrombotics
-
Ischemic stroke – anticoagulation for A-fib/flutter
-
Ischemic stroke – thrombolytic therapy for patients arriving within ii h of symptom onset
-
Ischemic or hemorrhagic stroke – antithrombotic therapy by day 2
-
Ischemic stroke – belch on statins*
-
Ischemic or hemorrhagic stroke – stroke didactics
-
Ischemic or hemorrhagic stroke – rehabilitation assessment
-
VTE prophylaxis inside 24 h of arrival
-
Intensive care unit VTE prophylaxis
-
Anticoagulation overlap therapy*
-
Platelet monitoring on unfractionated heparin*
-
VTE discharge instructions
-
Incidence of potentially preventable VTE
Table 7
EHR certification criteria that mention laboratory results equally function of the functional requirement (42 CFR 170.302, 304, 306)
-
Incorporate laboratory test results (general benchmark)
-
Generate patient lists (laboratory results equally criterion) (general criterion)
-
Computerized provider order entry (CPOE) (ambulatory, inpatient)
-
Patient reminders (convalescent)
-
Clinical decision support – implement rules (ambulatory, inpatient)
-
Electronic copy of wellness information* (ambulatory, inpatient)
-
Timely admission (for patients) (ambulatory)
-
Clinical summaries* (ambulatory)
-
Exchange clinical data and patient summary tape* (ambulatory, inpatient)
CMS finalized equally reporting requirements only those CQMs for which there are available electronic specifications (as of the date of the Last Rule). CMS indicates in the Final Rule that additional CQM volition be included in proposed Phase 2 meaningful utilise requirements.
Meaningful Apply Requirements Most Applicable to Laboratories
The meaningful use requirement most directly relevant to laboratories is one from the menu set objectives:
"More 40% of all clinical lab tests results ordered by the EP or past an authorized provider of the eligible infirmary…whose results are either in a positive/negative or numerical format are incorporated in certified EHR engineering science every bit structured information."
Regarding the definition of "structured" information in this context, the Final Dominion states that (p.44346):
"Structured data is not fully dependent on an established standard…Structured data inside certified EHRs technology merely requires the organisation to be able to place the information as providing specific data. This is commonly accomplished by creating fixed fields within a tape on file but not solely accomplished in this manner."
While CMS highly encourages electronic data exchange of laboratory results, the mensurate does not include a specific requirement for transmission or electronic receipt of lab results (although such a requirement is expected in future stages). Meeting the above requirement, however, in almost settings volition exist realistically possible but with an electronic interface between the laboratory information system (LIS) and the EHR (rather than through manual entry).
Some of the cadre and menu set meaningful use objectives include laboratory test results as part of the required information elements. The meaningful use core objectives and menu set objectives that specifically mention laboratory test results or diagnostic examination results in the dominion are denoted in Tables one–four. In addition, several of the ONC EHR certification criteria (encounter below) specify functional requirements that include handling of laboratory and/or diagnostic examination results in EHRs. Some of these certification requirements that involve laboratory results underpin meaningful use objectives in the CMS Final Rule that may not mention the laboratory results specifically. Examples include EHR capabilities to implement decision support rules based on laboratory results and to provide patients with online access to clinical information that includes laboratory results.
Twelve of the CQMs in the Stage 1 meaningful utilize requirements for eligible professionals include measures that include or depend upon laboratory testing. For example, the CQM entitled "Diabetes: Hemoglobin A1c Poor Command" requires reporting of the pct of patients between 18 and 75 years erstwhile with diabetes (type 1 or two) who had hemoglobin A1c greater than 9.0%. Three of the reportable CQMs required of hospitals include or depend upon laboratory testing. The CQMs that involve laboratory testing are denoted in Tables 5 and 6.
Computerized Physician Lodge Entry (CPOE) for laboratory test orders was a requirement that was initially included in the CMS-proposed Acting Final Rule; however, the CMS chose to remove the CPOE requirements for laboratory test requirements for Stage 1 in the Final Rule. It is made clear in the Final Rule, however, that CMS expects to include CPOE requirements for laboratory tests in Stage 2. In addition, a CPOE requirement for laboratory test orders are specifically included in the electric current ONC EHR certification criteria.
ONC CERTIFICATION CRITERIA FOR EHRs
In July 2010, the Department of Health and Homo Services and the Role of the National Coordinator for Health Information Engineering (ONC) published the Final Rule: Health Information Engineering science: Initial Ready of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Tape Engineering science (45 CFR Part 170).[six] This rule identifies the functional and technical capabilities that the EHR technology and systems must possess and demonstrate in order to ensure that uses can utilise such technology to achieve Stage 1 meaningful apply criteria:
"…certification criteria establish the required capabilities and specify the related standards and implementation specifications that serve as an electronic health record (EHR) technology will need to include to, at a minimum, back up the achievement of meaningful use Phase ane by eligible professionals, eligible hospitals, and/or disquisitional access hospitals…under the Medicare and Medicaid EHRs Incentive Programs."
The Final Rule sets forth the following definitions of certified EHRs applied science (170.102):
"Certified EHR Technology means: (1) A Complete EHR that meets the requirements included in the definition of a Qualified EHR and has been tested and certified in accordance with the certification program established by the National Coordinator equally having met all applicable certification criteria adopted by the Secretarial assistant; or
(2) A combination of EHR Modules in which each constituent EHR Module of the combination has been tested and certified in accordance with the certification program established by the National Coordinator equally having met all applicable certification criteria adopted by the Secretary, and the resultant combination also meets the requirements included in the definition of a Qualified EHR.
Complete EHR means EHR engineering science that has been developed to encounter, at a minimum, all applicable certification criteria adopted by the Secretarial assistant."
Elsewhere in the Last Rule, ONC defined an EHR Module and added clarification equally follows:
"…'any service, component, or combination thereof that tin meet the requirements of at least ane certification criterion adopted by the Secretary.' Consequently, EHR Modules, past definition, must provide a capability that can be tested and certified in accordance with at to the lowest degree one certification benchmark adopted by the Secretary."
and,
"An EHR Module could provide a single adequacy required past one certification criterion or information technology could provide all capabilities merely one, required by the certification criteria for a Complete EHR."
The ONC rule includes certification criteria that are applicable generally to EHRs and criteria that are applicable more than specifically to EHRs designed for ambulatory and for inpatient settings. While the ONC certification criteria marshal with and complement the meaningful use requirement in the CMS EHR incentive programs, the distinction between the CMS and ONC rules is important to understanding and interpreting the regulations. The ONC rule describes the capabilities that certified EHR technology must be able to demonstrate to support the apply of the EHR in a mode that meets the meaningful apply objectives of the CMS dominion. Certification criteria also crave that EHR technology can generate reports for each meaningful use objective measure that is per centum based (including numerator, denominator, and percentage). The specified capabilities include compliance with data standards in certain circumstances or for particular functions. The ONC dominion makes a bespeak that the rule is not intended to specify when or how persons or organizations using EHR technology must implement particular capabilities in their environments. Rather, the "how" of using EHRs is the purview of current and future meaningful use requirements:
"…we anticipate that future meaningful use objectives and measures will specify, as necessary and advisable, the conditions which sure health care providers volition need to use adopted standards and implementations specifications."
Certification Criteria and Standards Most Relevant to Laboratories
Several of the certification requirements for EHRs specifically mention laboratory and/or diagnostic test results, and some of these align with meaningful use objectives that may not overtly specify laboratory results. EHR certification criteria that specifically mention laboratory results equally office of the EHR functional requirements are listed in Tabular array 7.
The certification criterion that near straight relates to laboratory testing is a requirement for EHR technology in full general in 170.302:
(h) Contain laboratory test results—(i) Receive results.
Electronically receive clinical laboratory exam results in a structured format and display such results in a man readable format.
(2) Brandish test report data.
Electronically display all the information for a test written report specified at 42 CFR 493.1291(c)(1) through (seven).
(3) Incorporate results.
Electronically aspect, associate, or link a laboratory test result to a laboratory order or patient tape.
This certification criterion just states that EHRs must exist able to receive laboratory results in a structured format. The dominion does not impose any further or specific requirements for what constitutes a "structured" format in this context, stating:
"…we practise not believe that it is within the scope of this rule to dictate the standard by which laboratories transmit test results."
The ONC certification requirement correlates with the CMS meaningful use requirement, which states basically that 40% of clinical lab test results whose results are either in a positive/negative or numerical format are incorporated into EHR applied science as structured data. Equally described earlier, the clarification of structured data in the CMS rule on meaningful use states that "structured data within certified EHR technology merely requires the arrangement to be able to identify the data as providing specific information."
The merely requirement relating to the content and fashion for laboratory results brandish in the certification benchmark above is that EHRs display elements that are specified in the CLIA rule (42 CFR 493.1291 (c)(i) through (seven)), which states:
(c) The examination report must betoken the post-obit:
-
For positive patient identification, either the patient'southward name and identification number or a unique patient identifier and identification number.
-
The name and address of the laboratory location where the test was performed.
-
The test study date.
-
The exam performed.
-
Specimen source, when appropriate.
-
The examination event and, if applicable, the units of measurement or interpretation, or both.
-
Any information regarding the condition and disposition of specimens that practice non run across the laboratory'south criteria for acceptability.
No other requirements pertaining to how laboratory consequence data are displayed in EHRs are included in the certification criteria.
Some other EHR certification benchmark that relates specifically to laboratory testing includes the adequacy for CPOE for laboratory orders, both in ambulatory and in inpatient EHRs. The deviation between this requirement and the CPOE requirement in the meaningful use objectives may exist easily confused. To clarify, this requirement for CPOE for laboratory orders is a adequacy that an EHR must possess to become certified. This is in distinction to the meaningful use criteria, in which the apply of CPOE for laboratory orders is non required for Stage 1. This certification criterion paves the way for the expected requirements of CPOE for laboratory orders in Stage two of meaningful use.
Data Standards for Electronic Wellness Information, Including LOINC
In addition to the certification requirements for EHRs technology to support meaningful use in Stage 1, the Final Rule sets forth the HIT standards that take been deemed to have been adopted by the Secretarial assistant. Standards designated in the rule include:
-
Content exchange standards, including HL7 version 2.5.1 and/or version two.3.1 for certain public wellness information reporting requirements (170.205).
-
Vocabulary standards for representing electronic health information, including ICD-nine-CM, SNOMED CT, and Logical Observation Identifiers Names and Codes (LOINC) (170.207).
-
Standards for protecting the exchange of electronic health information, including encryption standards (170.210).
The deemed standards are in turn referenced as part of specific certification requirements and implementation specifications. For instance, convalescent EHR systems must enable a user to create an electronic copy of a patient's clinical data that includes a problem list (170.304(f)) that uses either vocabulary standard ICD-9-CM or SNOMED CT. Some other case is the requirement for inpatient EHR systems to submit reportable lab results to public wellness agencies (170.306(chiliad)), which requires the use of HL7 v2.five.1 for that particular criterion.
LOINC is specified in the ONC dominion as a vocabulary standard for representing laboratory examination results; however, information technology is important to realize that the requirement in the regulation regarding LOINC at this time is that certified EHR engineering must be able to re-employ a LOINC when it has been received from the laboratory and such lawmaking is accessible in the EHR. Specifically, the rule states that the HHS Secretary adopts LOINC as a standard for laboratory test results (only) "when such codes were received inside an electronic transaction from a laboratory." In other words, when received from a laboratory as LOINC codes, the EHRs must be able to use those LOINC codes for other certification criteria in which use of laboratory data is required, such as electronic copies of health information for patients (170.304(f)), clinical summaries (170.304(h)), and others. The EHR certification criteria that specifically reference LOINC as a requirement are noted as function of Table 7. It is worth reiterating here that neither the current ONC certification criteria and implementation specifications nor the Stage one CMS meaningful utilize requirements require laboratories to transmit results using LOINC codes.
ONC Temporary Certification Programme for EHR Technology
Elsewhere in the ONC's Final Rule (45 CFR Office 170 subpart D), in June 2010, the ONC established a Temporary Certification Plan for EHR Technology. This program authorizes ONC-Authorized Testing and Certification Bodies (ONC-ATCBs) to examination EHR technology and to certify that EHR systems meet the standards, implementation specifications, and certification criteria as specified in the Final Dominion. The rule also describes how organizations tin can get ONC-ATCBs. The temporary certification program will be replaced eventually by a permanent certification plan. As of this writing, three organizations take qualified as ONC-ACTBs:
-
Certification Commission for Wellness It (CCHIT).
-
Drummond Grouping Inc. (DGI).
-
InfoGard Laboratories Inc.
An up to appointment list of ONC-ATCBs may be plant on the ONC web site at http://healthIT.hhs.gov/ATCBs. ONC maintains an up to date Certified Hitting Product List (CHPL) at http://onc-chpl.force.com/ehrcert. As of this writing, the CHPL web site lists 115 systems from 79 vendors that take been certified by ONC-ATCBs nether the Temporary Certification Plan.
Other Related ONC Programs
There are two other ONC-sponsored programs (from HITECH) of which pathologists and laboratories should be aware, which have been created to foster EHRs adoption: Regional Extension Centers (RECs) and Wellness Information Exchanges (HIEs).
The HITECH Human action allocated $677 1000000 to the establishment of Wellness Information Technology Regional Extension Centers (RECs) that will offer health care providers with technical assistance, guidance, and information on best practices to support and accelerate health care providers efforts to become meaningful users of EHRs.[7] RECs embrace all geographic regions of the The states. As of this writing, 62 RECs for practitioners have had funding appear and an additional 46 RECs accept been funding to assistance critical access and rural hospitals adopt certified EHR applied science. The RECs will focus mostly on clinicians providing master intendance services, with an accent on private and small-scale grouping practices (fewer than x providers). The RECs aim to provide help in EHRs product selection and implementation also as guidance on improving clinical administrative workloads to use EHRs most finer, and coming together legal, regulatory, and other requirements. The relevance of RECs to laboratories is that understanding RECs efforts in their area may provide an opportunity for laboratories to piece of work with the RECs, physician offices, and EHR vendors to meliorate success in implementing laboratory interfaces.
The HITECH Act besides funds the State Wellness Information Exchange Cooperative Understanding Program.[viii] Under this programme, the federal government has awarded $548 meg to support exchange of health information across different health care organizations through the establishment of HIEs. HIEs are groups of organizations working together with a goal of improving the quality of health care delivery in a region, typically a state, by focusing on standards-based interoperability of healthcare information and healthcare information systems. The goals, capabilities, and participants in HIEs volition vary across states, and participants in HIEs will vary across states. Reflecting a priority for the electronic exchange of laboratory results in HIEs. In July 2010, the ONC issued a Plan Information Find (Pivot)[9] that directed HIE efforts and award grantees to focus their efforts on receipt of structured laboratory results every bit 1 of three priorities for HIEs for 2011 (the others being east-prescribing and sharing patient care summaries across organizations). HIE efforts in a laboratory, state, or region, although varying in maturity, may have relevance to laboratories that either need to or wish to participate or that come across value in leveraging an HIE'due south capabilities to facilitate laboratory information exchange.
OTHER IMPLICATIONS FOR LABORATORIES OF EHR MEANINGFUL Use REQUIREMENTS
The HITECH Act and the CMS EHR incentive/penalty programs aim to increment the use of EHRs by health care providers. Greater implementation of EHRs has important clinical, operational, and business implications for laboratories, particularly those that serve doc practices. Laboratories can expect to see a dramatic increase in the expectations for LIS-EHR electronic interfaces for test results and laboratory test orders (eventually if not immediately), as physicians implement EHRs more than widely. The increment in expectations for electronic interfaces volition stalk from (1) the fact that laboratory effect interfaces will facilitate coming together meaningful use requirements (see to a higher place) for incorporation of laboratory data in an EHR and (ii) the fact that implementing an EHR more often than not will lead to the desire to have laboratory results delivered electronically. Further to the latter point, once a physician practice has an EHR in identify, the expectation will understandably follow that laboratory results volition be electronically incorporated into the electronic record instead of existence entered manually or instead of being viewed on separate laboratory web portal sites or the like.
Meaningful utilise requirements and the expected increase in EHR implementation offering some opportunities for laboratories. Implementing an electronic interface from the laboratory information system to a provider's EHR tin can facilitate meeting the requirement for the incorporation of clinical laboratory examination results into the EHR, and for higher volume practices, meeting the requirement is realistically possible to achieve just with an electronic interface from the laboratory (although results interfaces are not specifically mandated in the Stage ane meaningful employ benchmark). Because many of the CQMs that are options for clinicians to report involve laboratory tests [Tables 5 and vi], laboratories may notice opportunities to facilitate their clients' power to encounter these meaningful use reporting requirements. At minimum, eligible providers volition likely desire to receive test result data in a manner that will automatically populate information into their EHRs and in turn facilitate CQM reporting to see meaningful use criteria.
Challenges for Laboratories
For laboratories, more widespread and time-sensitive expectations for LIS-EHR interfaces nowadays substantial challenges and bring with them considerations that get across the specific requirements mentioned in the Final Rules. Implementing interfaces between LISs and EHRs is non "plug and play," and requires considerable attention to technical too equally organizational/authoritative factors. In addition, at that place may be considerable expenses involved in implementing interfaces and maintaining interfaces. There may be lack of command or involvement bachelor to the laboratory for EHR management at doc sites. Poor process design resulting in issues with laboratory testing may exist blamed inappropriately on the laboratory.
Primary amid the challenges is that the laboratory has the responsibility for the accuracy of test upshot data that are transmitted from the laboratory to receiving systems. The CLIA (Clinical Laboratory Improvement Amendments) regulation states this responsibility specifically (42 CFR 493.1291(a)):[10]
"The laboratory must have adequate manual or electronic system(s) in place to ensure exam results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final study destination, in a timely manner. This includes the following:…(2) Results and patient-specific data electronically reported to network or interfaced systems."
As role of its stated goal to promote the electronic exchange of wellness information and in recognition of the fact that laboratory information is an integral part of EHRs, CMS recently issued a revised guidance related to interpretation and compliance with CLIA requirements for laboratory result reporting and laboratory data exchange. This guidance was issued in March 2010 in the form of the document entitled "Issuance of Revised Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services in Appendix C of the Country Operations Manual." [11] Generally, such interpretive guidance in the Land Operations Transmission is the guidance for surveyors for interpretation and awarding of CLIA requirements when surveying or inspecting laboratories. In the document, the CMS indicates that this is the offset of a series of forthcoming memoranda from CMS on electronic substitution of laboratory information. The document provides of import direction to laboratories on coming together CLIA requirements and includes revisions in requirements related to the electronic exchange of laboratory information, data retention, and management of corrected laboratory reports in EHRs. Guidance is also offered related to the definition of individuals who are authorized to receive laboratory results and how others may be designated by the authorized individuals to receive laboratory information. An extensive section of oftentimes asked questions includes further clarification on the higher up topics besides every bit clarification on HIEs and designating "agents" for the receipt of laboratory test results.
When coming together such requirements as the above, as well as in pursuit of a stewardship office for the quality of laboratory data in medical do, laboratories demand to be enlightened that EHRs may vary in their effectiveness of issue display. Laboratory study elements that may be subject to variation in EHRs include:
-
Reference range management.
-
Explanatory comments and footnotes.
-
Abnormal result flags.
-
Preliminary reporting and updates.
-
Reporting and documentation of corrected results.
-
Unsolicited results and reflex test order/results.
-
Name and address of performing laboratory.
EHR certification requirements dictate only that the CLIA-mandated elements (come across previous section) that establish a test report must be displayed in the EHRs and have no further requirements as to format, readability, or display. The issues related to the higher up items equally well as other aspects of more circuitous laboratory effect display commonly arise during the course of interface implementation. Failure to address these issues might have negative consequences, which include misinterpretation of laboratory results and the perception (however inappropriate it might be) that the laboratory is responsible for less than optimal display of laboratory results in EHRs and interpretive errors that might arise from such display.
Laboratories must consider other technical considerations necessary to encounter the need for LIS-EHRs interfaces. Whether laboratories interface straight from their LIS to EHRs interfaces or interface through some type of integration services provider or interface engine, the capability volition exist necessary to interface with a wide variety of EHRs and vendors that are available. As of this writing, according to the ONC CHPL spider web site (http://onc-chpl.force.com/ehrcert), 115 EHRs take been certified from 79 vendors. Laboratories will need to establish a network connectivity model (e.thou., virtual private network, VPN) for electronic communication with the EHR sites. Laboratories volition need to secure the availability of technical support expertise for implementing and supporting the interfaces. Compatibility with ONC-mandated interoperability standards is important, peradventure non as much in the current requirements, but certainly with an eye toward the future.
Operational Considerations for Laboratories and LIS-EHR Interfaces
Attention to the operational aspects of LIS-EHR results reporting interfaces is necessary for successful implementation and ongoing support. Some of the more important factors are summarized here:
-
The importance of and methods for maintenance of the laboratory test definitions in the EHR must be understood, especially when it comes to change control. For instance, volition clients be changing their laboratory test definitions settings in the EHR, which in plough volition affect the correct filing in the EHR of test results that are received in interface transmissions?
-
Laboratory procedures should address alter control and communication that should occur when the laboratory makes to the examination definition in its own LIS. Some of these changes, such as test definition updates or reference range adjustments, may bear on interface manual and/or the brandish of results in the receiving EHR and, therefore, procedures are necessary for communicating such changes to the interfaced sites.
-
Ongoing troubleshooting of interfaces and interface-related customer back up issues will grow as the number of interfaces abound, and must exist accounted for in laboratory management planning.
-
Overall customer site contact and appointment will exist of import to be able to accept successful communication of laboratory results electronically on an ongoing basis and to manage changes. Implementing EHRs interfaces requires some involvement past back up personnel at the client site; withal, getting access to and attending of such people at client sites can be challenging and frustrating if such personnel resources at any particular site fifty-fifty be.
-
There may exist a need to train EHR interface clients as to how laboratory results are viewed.
-
A process for handling and communicating corrected results must be implemented and validated.
-
Depending on the practice setting, the establishment of procedures may be necessary for the communication of laboratory test results in situations in reanimation situations when the interface is non available.
-
Providers with differing clinical needs, different examination mixes, and/or dissimilar EHR solutions may crave unlike laboratory workflow or at least must be accommodated within laboratory operations; withal, this need must be balanced against reduced efficiency that may outcome from creating likewise many exceptions or variations in laboratory procedures.
-
LIS upgrades or updates must also take into account whatever effects on interfaced systems and sites.
Predictable Requirements in Future Stages of Meaningful Use
While current requirements for Stage 1 of meaningful use criteria and related data standards adopted by HHS/ONC are relatively limited with regard to the laboratory, anticipated requirements in the future stages of meaningful use tin can be expected to take a greater bear upon on the laboratory. As mentioned, CPOE equally a requirement for laboratory test orders was removed from Stage 1, but is expected to be present in Stage 2. When implemented, electronic orders for laboratory tests volition originate in the CPOE module of EHRs and volition be subject area for the vagaries of how CPOE is implemented in unlike EHRs. Laboratories should expect to have processes in identify to handle electronic transmission of orders from interfaced clients in advance and expectation of these requirements. Test carte du jour/examination catalog management will exist of paramount importance, given the diversity of the EHR environment (equally evidenced by the number of EHRs already certified). CPOE systems must be configured correctly for laboratory examination ordering in terms of menus, lodge tests, and the options for how test order choices are presented to the ordering dr.. Test requests in CPOE systems must include the capability to include all the items that CLIA mandates in test requests and, furthermore, the CPOE systems should be prepare up to accommodate other nuances of laboratory test ordering, including "enquire at guild entry" questions and provision of clinical information when necessary. There are significant negative consequences for the laboratory of improperly designed or implemented EHR CPOE processes (even if the laboratory has picayune influence or opportunity for involvement in the implementation process), such as wrong, incomplete, and/or inappropriate test orders as well every bit inefficiencies owing to CPOE problem resolution. Depending on the clinical setting, the CPOE procedure for laboratory tests may need to account for time to come orders, duplicate order treatment, and canceled social club handling. Billing problems may arise also if not factored into planning.
Stage ii meaningful use criteria are expected to include requirements for electronic transmission of diagnostic test results that extend beyond the current applicability to numeric results and yes/no results and also include pathology results and genetic tests (in addition to radiology, cardiac imaging, pulmonary office tests, etc.).
As HHS has adopted LOINC and HL7 v2.5.one in certain EHR certification criteria, information technology might be expected that broader requirements regarding apply of these data standards may be forthcoming in hereafter stages. LOINC, and the capabilities of laboratory information systems to adjust LOINC, is of particular involvement for laboratory test information direction as laboratories examine the capabilities of their LISs. In line with the HHS-stated goals, broadly speaking, at that place will be greater expectations for exchange of healthcare information with unaffiliated entities and more decision back up in general, both of which can be expected to involve laboratory tests.
CONCLUSIONS
Every bit a consequence of the contempo federal government efforts under the HITECH Act, most notably EHR meaningful employ and EHR certification criteria, use of EHRs can be expected to increase dramatically in the coming months and years. Meaningful employ criteria dictate how eligible providers and hospitals must utilize EHRs technology, while certification standards specify what capabilities that EHR must possess in guild to support meaningful use. Some of these criteria and requirements are directly applicable to laboratory testing currently, and more than promise to be applicable to laboratory testing in the future.
Equally EHR uptake expands, in that location volition be greater expectations for electronic interchange of laboratory data, and laboratories must fix at present to see the needs of the time to come environment. Implementation of LIS-EHR interfaces promises to be a major priority in the future and a challenge for laboratories serving outreach clients. In improver, some of the new and futurity requirements and programs may provide other opportunities for ways that laboratories can ameliorate serve their provider community.
Footnotes
REFERENCES
2. Hsiao C, Hing E, Woodwell DA, Socey TC, Cai B. Electronic medical record/electronic health tape use by office-based physicians: The states, 2009 and Preliminary 2010. Hyattsville, Dr.: National Center for Health Statistics. Available from: http://world wide web.cdc.gov/nchs/data/hestat/emr_ehr_09/emr_ehr_09.htm [cited on 2011 Jan eighteen]
v. Centers for Medicare and Medicaid Services, Section of Health and Human Services. 42 CFR Parts 412, 413, 422 et al. Medicare and Medicaid Programs; Electronic Health Record Incentive Programme; Final Dominion; published July 28, 2010. Available from: http://edocket.admission.gpo.gov/2010/pdf/2010-17207.pdf [cited on 2010 December 8]
half dozen. Section of Health and Human Services. 45 CFR Role 170. Health Information technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Engineering; Final Dominion; published July 28, 2010. Bachelor from: http://edocket.access.gpo.gov/2010/pdf/2010-17210.pdf [cited on 2010 December 8] [PubMed]
11. Centers for Medicare and Medicaid Services, Section of Health and Human Services. Clinical Laboratory Improvement Amendments of 1988 (CLIA) – Issuance of Revised Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services in Appendix C of the State Operations Manual to Facilitate the Electronic Exchange of Laboratory Information; published March ane, 2010. Bachelor from: http://www.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter10-12.pdf [cited on 2010 December 8]
Articles from Journal of Pathology Informatics are provided here courtesy of Elsevier
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3049251/
0 Response to "What Government Regulation Is Intended to Promote the Use of Ehrs"
Post a Comment