GE Healthcare Healthcare IT

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1 GE Healthcare Healthcare IT May 06, W. Northwest Highway Barrington, IL Farzad Mostashari, MD, ScM Department of Health and Human Services Office of the National Coordinator for Health Information Technology Attention: 2014 Edition EHR Standards and Certification Criteria Proposed Rule Hubert H. Humphrey Building, Suite 729D 200 Independence Ave., SW. Washington, DC Attention File Code RIN 0991 AB82 [Filed Electronically] Re: Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology Dear Dr. Mostashari: GE Healthcare (GEHC) appreciates this opportunity to comment on the proposed rule on the 2014 Edition EHR Standards and Certification Criteria Proposed Rule. GE Healthcare provides medical technologies and services shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, bio-pharmaceutical manufacturing technologies, performance improvement and performance solutions services helps our customers deliver better care to more people around the world at a lower cost. GEHC s healthcare information technology (HIT) products cover a broad span of clinical, administrative, and financial applications serving customers who range from small physician practices to large enterprises and integrated delivery networks. Our electronic health record (EHR) products and related technologies, including imaging IT, are especially relevant to these comments, and to the HITECH Act. Our electronic health record (EHR) products and related technologies, including imaging IT, are especially relevant to these comments, and to the HITECH Act. We appreciate the care and thoughtfulness that went into development of this proposed rule. We especially appreciate the clear and effective efforts by ONC to listen to and respond to industry feedback on Stage 1 of the EHR Incentive Program and initial suggestions for Stage 2. Our letter includes overall comments and the attachment provides detailed recommendations on proposed certification criteria, standards, changes to the certification program and policy issues.

2 Key Recommendations GE Healthcare supports strongly the EHR Incentive Program. With the changes we propose, Stage 2 of the EHR Incentives program will enable increasing numbers of healthcare professionals and hospitals to adopt and use meaningfully EHRs and to achieve the full benefits of broadly adopted, interoperable electronic health record (EHR) systems. Increased use of such EHRs and other HIT will help move our nation to a more coordinated, integrated, and patient-centric health system. 1. Stage 2 Timing and Implementation We strongly support and appreciate CMS proposed one-year extension of Stage 1 of meaningful use. Along with many others in the industry, we have advocated for many months for this essential action. As coordinated with the ONC proposed rule on standards and certification, this extension will benefit all providers pursuing meaningful use in FY/CY 2013, as they would have been responsible for implementing Stage 2 certified EHRs. The changes proposed for timing and certification will substantially mitigate the problems with the prior timeline. We are, however, concerned that the likely timing for release of the Stage 2 final rules, along with the scope of proposed Stage 2 meaningful use, clinical quality measure, and certification changes, presents a major challenge for vendors and providers to develop, test, and implement 2014 Edition certified EHRs in a very compressed timeframe. Given this concern, we urge ONC to take these time constraints into careful account in its decisions on the scope of the Stage 2 final rule and to expedite release of that rule. We also encourage ONC to consider allowing providers in Stage 1 in 2014 to use 2011 Edition certified EHR technology at their discretion given the need for substantial deployment to providers within a very narrow window. 2. Meaningful Use Measurement and Reporting Our CMS and ONC comments provide detailed suggestions to improve the accuracy and feasibility of reporting on progress against meaningful use measures. Based on Stage 1 experience across vendors and providers, we urge ONC to ensure that: (1) definitions used in the certification process are clear and enable accurate and efficient reporting and testing, (2) definitions of key terms and concepts are explicit in measure specifications and the final rule preambles, and (3) CMS and ONC rethink their intention to require providers and their EHRs to track when functions are enabled or disabled or actions triggered. The need to measure and report on such events could impede clinical flexibility and is impractical and burdensome to user experience. 2

3 3. Clinical Decision Support and Clinical Quality Measures GE Healthcare is committed to clinical decision support (CDS) and accurate measurement and reporting on clinical quality. Our Medical Quality Improvement Consortium (MQIC) is a reflection of that commitment. We do, however, make several specific recommendations to improve ONC s proposals regarding CDS and Clinical Quality Measures (CQM). These include: ONC should address identified concerns with counting and reporting CDS interventions. CDS functionality in an EHR should allow providers considerable flexibility in designing CDS and we support allowing various scenarios for evidence-based interventions ONC should make linked referential CDS and the Infobutton standard optional and not required for certification or provider use. We suggest elimination of the proposed requirement that CDS interventions be triggered when a summary record is incorporated in the EHR. We recommend retaining Stage 1 Clinical Quality (CQM) Measure measures and CQM reporting requirements for providers in Stage 1 in 2014, but implementing these measures using applicable the 2014 Edition specifications. We support the "calculate and transmit" aspects of the CQM criteria but oppose the requirement to capture all data in the quality data model (QDM) and to export it using the vocabularies in the QDM, a substantial requirement well beyond the rest of meaningful use data capture and information exchange. We recommend that one of the alternatives identified by ONC be adopted, such as a constrained QDM, or a focus on only those data elements required for selected quality measures. In addition, we believe that the Export criterion should be optional and that, if it is not, we agree with ONC that Complete EHRs should not have to certify on Export. 4. Health Information Exchange and Interoperability We are very pleased that CMS and ONC propose important steps to increase the extent and value of health information exchange and interoperability in Stage 2, including a single clinical summary standard, clinical reconciliation, and specification of transport standards. We support the proposal for the Consolidated CDA (CCDA) as the single standard for conveying clinical content and provide detailed comments on data content and the need for more clarity on definitions of referrals and transitions. We propose that incorporation of CCDA elements into the EHR be limited to the three data elements included in clinical reconciliation (i.e., problems, medications, and medication allergies) and that the Stage 1 requirement to receive and display the clinical summary be retained. Finally, we suggest that the same data transport standards referenced under Transmit be referenced under Incorporate, which should be revised as Receive and Incorporate, to ensure an effective system of transmission and receipt of clinical summaries. 3

4 We strongly support NwHIN Exchange-related/SOAP standards as counting toward the numerator for electronic exchange of clinical summaries and being an option for certification. We provide specific suggestions on enhancing this proposed option, including an explicit focus on the ability to use query-based exchange models in addition to directed exchange, as well as on greater clarity for the Direct specification in certification testing. 5. Patient Engagement We are strong supporters of increased patient engagement and on including robust patient engagement objectives and measures in Stage 2 of meaningful use. We specifically support both view, download, and transmit and secure messaging. At the same time, our detailed comments propose refinements to these provisions, including ensuring that providers have the flexibility that CMS proposes with regard to specific data transport methods and that the proposals for online patient image access are revised to reflect technical realities. 6. Access to Imaging Results We strongly support CMS s proposed provider-focused imaging objective and measure for Stage 2. Images provide critical information used by providers to diagnose and manage disease; image access should enhance care and prevent some duplicative imaging tests. We agree with CMS to not require images to be stored in the EHR, but to be accessible through the EHR, such as by a link to a PACS or other image archive. Based on our extensive experience with EHRs and imaging-focused HIT (e.g., PACS and RIS), we suggest refinements to ONC s certification criteria. 7. Patient Safety and Quality We are strong supporters of patient safety and reporting via Patient Safety Organizations (PSOs). We do not believe, however, that EHRs are the best data collection/reporting vehicles for safety events for such organizations or generally and do not support ONC s moving ahead with its proposal to use EHRs in this manner. In addition, although highly supportive of vendors having quality system processes in place and the general approach proposed by ONC of describing the nature of each company s quality processes, we are very concerned that ONC did not release a draft of its Quality Management System document at the time that the proposed rule was issued (and not as of April 29). Such a document will require extensive industry and expert review and feedback before finalization. It is also essential that companies that are currently following existing ISO or FDA standards and processes not in any way be disadvantaged relative to the ONC approach. 8. Transparency Although we value transparency highly and are clear in pricing with our customers, we do not agree with ONC s specific proposal for on this issue. The proposed, highly intrusive requirements are unnecessary and inconsistent with the nature of software and how it is purchased, including the need to focus on total cost of ownership. We also oppose ONC s 4

5 proposal that certification bodies disclose detailed information associated with the certification process; such disclosure could compromise intellectual property and trade secrets and mislead purchasers. 9. Certification Program Revisions We agree with and appreciate the proposed changes to the certification program. These revisions involve a Base EHR, a Core EHR, and Menu EHR items, with providers needing a Base EHR regardless of their meaningful use stage and then only those elements of the Core and Menu applicable based on their current stage, any exclusions, and menu items pursued. We also agree with the associated approach to security testing and ask for clarifications on potential scenarios. *** We appreciate the care and thoughtfulness that went into development of this proposed rule and ONC s sincere efforts to be responsive to industry feedback on Stage 1 and the upcoming Stage 2. We urge ONC to give very careful consideration to these comments and to those of our industry partners, such as the Electronic Health Records Association and HIMSS. GE Healthcare appreciates the opportunity to submit comments on these important issues. If you have questions on our comments, please do not hesitate to contact me. Sincerely, Mark J. Segal, PhD Vice President, Government and Industry Affairs GE Healthcare IT [email protected] cc: John Schaeffler Executive - Government Relations Leader General Electric Company 5