ASCO 50th Anniversary

Perspective

Oncology in the Digital Health Age By Peter Paul Yu, MD Palo Alto Medical Foundation, Palo Alto, CA

In 2006, ASCO, through the leadership of its Clinical Practice Committee, Information Technology Committee, Cancer Research Committee, and the Quality Advisory Group, entered the digital health care world with the creation of the Electronic Health Record Working Group (EHR WG). Led successively by Patricia Ganz, MD (2006-2007), John Cox, DO, MBA (2008-2009), Peter Yu, MD (2009-2013), and Jeremy Warner, MD, MS (2013-present), the now-renamed Health Information Technology Workgroup (HIT WG) has kept ASCO at the forefront in medical informatics development. The inaugural event for the HIT WG was the ASCO Electronic Health Record Policy Roundtable held January 23-24, 2007, chaired by ASCO President Gabriel Horobagyi and ASCO Board Director Robert Miller, which resulted in a white paper stressing the opportunities for electronic health records (EHRs) to support patients through their cancer experience.1 Over 20 organizations representing professional societies, federal agencies, private payers, and patient organizations met to address the potential for EHRs to improve the health care of patients with cancer and health care operations of the cancer world. Since then, the HIT WG has three identified areas of interest: 1. Provide ASCO members with the requisite knowledge to guide the selection and implementation of EHRs. 2. Foster the development of functionality within EHRs to support cancer care, including semantically clear data definitions, clinical decision support systems and interoperability and exchange of health data across platforms. 3. Represent the perspective of patients with cancer, health care providers, and health care systems in national public policy discussions and decision making.

Guidance on Evaluation and Implementation of EHRs The impetus for the formation of the HIT WG was the recognition by the Clinical Practice Committee that the future of health care and clinical practice would be dependent on HIT, which would transform health care much as it has transformed other critical industries. The initial focus was on improving the experience of patients with cancer by increasing the safety of chemotherapy administration through computerized provider order entry,2,3 improving documentation of health provider patient evaluation and medical interventions, and enhancing provider and patient communication. At that time, the interest in EHRs within ASCO resided primarily in community practices, and as a growing number of EHRs vendors emerged with Copyright © 2014 by American Society of Clinical Oncology

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products tailored to support the delivery of cancer care by community practices, a need arose among ASCO members for assistance in selecting an EHR for a practice. The 2007 ASCO Annual Meeting launched the Vendor Lab in the ASCO Exhibit Hall, which created a controlled environment for members to experience the performance of different EHRs products. Vendors were required to demonstrate the usability and functionality of their products for clinical applications such as chemotherapy ordering, appropriate dose modification, and identification of Quality Oncology Practice Initiative analytic cases. The same year, ASCO launched the biannual EHR Symposium, a stand-alone meeting that provided didactic lectures on EHRs and more stringent EHR vendor demonstrations. The following year, ASCO the released the EHR Field Guide (now out of print), which provided clinicians with information to help select and implement an oncology EHR. Also in 2008, ASCO launched a social networking Web site to facilitate discussions around HIT, which in 2010 became integrated into the newly formed ASCO Connection Web site. By 2009, four emerging tends became apparent to the EHR WG. First, as a greater percentage of oncology practices adopted EHRs, the need was shifting from guidance in selecting systems to guidance in optimizing the value of EHRs. Second, the need of large integrated health care delivery systems for enterprise EHRs with the capacity to meet their requirements was creating a new class of EHRs that oncologists would work with. Third, national health care policy would foster the use of digital health for research into health care outcomes of populations of patients, such as those with cancer, and promote greater coordination of care among providers to improve quality outcomes. Fourth, digital health is not restricted to physician office electronic medical records. Consequently, the 2009 HIT/EHR Symposium emphasized the secondary use of EHR data for improving health system operations and interoperability of health data. In 2010, the EHR WG was renamed the HIT WG, and in 2013, the HIT/EHR Symposium was merged into the ASCO Quality Care Symposium, then in its second year of existence, to shift the focus to the use of HIT to support improvements in the quality of cancer care delivery. Going forth, the HIT WG will provide a home for ASCO members with technical expertise in HIT that can support the programs of the Quality Care Committee, which itself evolved from the Quality Advisory Group that in 2006 had played an early role in establishing ASCO’s interests in digital health. An increasing number of oncologists now practice in large health care systems where decisions on how EHRs are config•

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ured are made by information systems departments with variable input from clinicians. Information systems departments depend on clinical input from selected physicians with informatics interests, subject matter experts who provide valued feedback and information on clinical needs. However, it is important that subject matter experts realize that their familiarity with EHRs is greater than that of other oncologists, who have limited interaction with system engineers and analysts. Insufficient communication with end users adds to the risk that the design and implementation of EHRs will not be satisfactory to users who are not subject matter experts. To give ASCO members the opportunity to interact directly with their EHR vendor, ASCO invited EHR vendors to host User Groups at the 2013 Annual Meeting, thereby giving oncologists the opportunity to speak directly to their vendors.

Advance the Performance Expectations of HIT in Support of Oncology EHRs were designed to replicate the paper medical chart experience. It was commonly thought that physicians trained in a paper world would feel most comfortable with an EHR that mimicked the look (graphical user interfaces) and organization of the paper chart. Although vendors believed that this would encourage earlier adoption of EHRs, the opportunity cost of not attempting a transformative change from the outset, one that could have radically improved productivity and quality, is in fact hampering physician acceptance of EHRs, as many physicians experience decreased productivity. The relative value unit– based system of physician payment, which prioritizes documentation of work rather than thought or patient interaction, has been equally detrimental to HIT by emphasizing documentation of information that has little value to patient care or decision making. In order to set standards for an oncology EHRs, in 2009, ASCO, the NCI, and the NCI Community Cancer Centers Program produced a white paper specifying basic EHR functionality needed to support cancer care, along with a set of semantically defined cancer data elements. It was hoped that the resulting document, Clinical Oncology Requirements for an EHR, would become an industry standard to guide EHR development.4 A common way to create an industry standard is to incorporate specifications into a certification process. At that time, the predominant certifying body for HIT was the Certification Commission for Health Information Technology (CCHIT). CCHIT establishes both certification requirements and testing processes through which EHR vendors obtain certification. Before the American Recovery and Reinvestment Act (ARRA), which later established the federal Meaningful Use program and its own certification process, CCHIT drove certification of EHRs in the United States. ASCO successfully applied to CCHIT to develop a new oncology certification program, which was built and launched in 2011 with leadership and contributions from members of the HIT WG.5 228

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National Health Care Policy, Reform, and HIT The Great Recession led to a federal stimulus program funded by ARRA. Embedded within ARRA is the HITECH Act, which established the MU incentive program that provides physicians and hospitals with payments for the acquisition and use of HIT. Providers must acquire EHRs certified to the specifications of the Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) and use the EHRs to meet performance standards stipulated by the Centers for Medicare and Medicaid (CMS). The ONC Policy Committee plays a key role in drafting the requirements for qualifying for MU incentive payments, with the final decision and administration of payments done by CMS. Providers and hospitals qualify for MU incentives funds when they meet certain criteria, which are designed to be phased in over several years starting with phase 1 in 2011; phase 2 in 2014; and phase 3, now scheduled for 2017. Along with the incentives, penalties for nonparticipation begin in 2015. Between May 2011 and January 2014, more than 347,000 health care providers and hospitals have received $20.5 billion dollars through the MU program.6 Without doubt, MU has accelerated the adoption of EHRs, although not without legitimate criticism. Although it has succeeded in raising the level of EHR adoption, providers and hospitals have struggled to develop the technical skills and operational knowledge necessary to successfully deploy systems under such an accelerated timetable. Furthermore, a common complaint among both EHR vendors and health care providers is that the need to rapidly adapt EHRs systems and provider workflows to qualify for MU incentive dollars has become a distraction to innovative changes that might otherwise have been brought about. As mentioned, although CMS administers the MU Program, the design of the program is largely done by ONC, another federal agency within HHS. The Institute of Medicine works closely with ONC on setting public policy in HIT. ASCO has participated in multiple Institute of Medicine Roundtable events and has gained a deep understanding of the overarching goals that underlie federal policy.6 In 2009, ASCO provided testimony before the ONC Policy Committee and has consistently provided public comment to ONC and CMS, signaling that the oncology community stands ready to participate in the transformative and disruptive change made possible by a national digital health system, while strongly advocating that MU needs to be meaningful to cancer specialists through the inclusion of oncology-relevant measures.7 To date, two MU objectives appear to have the most significance to oncology. First is the MU objective of reporting to registries. MU 2 criteria include the option to electronically report statutory required cancer data to state cancer registries using a reporting standard specified by the Centers for Disease Control and Prevention and the North American Association of Central Cancer Registries. The second is sharing of data to improve coordination of care and the aggregation of data across populations of patients to improve quality and drive new knowledge. Both of these require that cancer data be represented within the EHRs in such a manner that allows the data to

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be readily identified, extracted, and placed into a data transmission format that works between different EHRs—no mean feat, and a functionality that EHRs based on paper chart models were not designed for. The ASCO HIT WG began work on this important challenge in 2012. Molecular data represent a critical and new class of cancer data, one that is expected to play an increasingly important role in directing cancer treatment. Panomic (genomic, transcriptomic, proteomic, and metabolomic) data are far more complex than previous types of laboratory data and with a few exceptions lack well-established standards for testing methodology and reporting. This poses a major new challenge for digital representation of cancer data in HIT systems. ASCO is assisting the College of American Pathologists (CAP) to develop biomarker reporting standards and in the promotion of CAP’s digital transmission standard for pathology data, the CAP electronic checklists.8 ASCO is driving new standards for other types of cancer data based on the HL-7 data transmission standard known as the Consolidated Common Data Architecture. ASCO has designed a Consolidated Common Data Architecture breast cancer treatment plan and summary document, which was accepted by HL-7 as a draft standard in October 2013. It is now undergoing testing by the University of California Athena Breast Health Network under a grant from ONC. As evident from the above descriptions, there are many stakeholders in the oncology data ecosystem. Other organizations that play important roles in promoting the capture and reporting of cancer data include the National Cancer Database, American Joint Committee on Cancer, and Cancer Care Ontario. At the same time, the existence of too many standards is in itself a hindrance, as EHRs vendors cannot design to multiple standards, and clinicians cannot be held responsible for excessive data entry. To begin to bring into alignment the activities of cancer organizations, ASCO convened the Oncology Interoperability Standard Summit in February 2013 to bring together organizations and foster dialogue around sharing work. A second Summit will be held in 2014.

CancerLinQ and Rapid Learning Health Systems In 2006, the IOM initiated the Roundtable on Value & Science-Driven Health Care. As the MU Program was being formulated, the Roundtable began to study what a national digital health infrastructure might look like beyond MU and how to leverage the installed base of EHRs brought on by the MU program.9 IOM realizes that HIT is only a tool and not a panacea for a national health care system that fails to deliver high-quality health care at reasonable cost and with universal access, and equally challenging, a clinical research enterprise that is inefficient and in danger of becoming less relevant to the world. Although HIT can provide the data repositories and the interoperability of information systems that allow sharing of data, this is necessary but not sufficient for a true transformation of health care and research. True transformative change Copyright © 2014 by American Society of Clinical Oncology

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will require a model with the capability of driving innovation. Something was missing. Since 2005, Lynn Etherdge, a health care economist at George Washington University, has championed the concept that much as big data has transformed other fields of science such as astronomy, deep analysis of big data could transform health care and more importantly, do so rapidly.8 By aggregating data not from the limited number of patients who are treated on clinical trials, but from the vast number of patients treated in routine care, big data sets can be created that inform us about the real-world experiences of patients with cancer. Because big data derives from all patients, it can speak to the optimization of health care outcomes and drive comparative effectiveness research to better use limited health care dollars most efficiently. Etheredge called such a model for utilizing big health data to drive learning and innovation a Rapid Learning Healthcare System (RLS), and it has become accepted as the missing element. In August 2013, after more than a year of study and prototyping, the ASCO Board of Directors approved building an RLS for oncology (the first RLS in medicine), ASCO’s Cancer LinQ.8 CancerLinQ is not an EHR or a traditional registry, but an information system that interacts in real time with the EHRs of oncologists, drawing in data from EHRs and sending out clinical decision support, analytic reports, and a new generation of knowledge products to participating practices. It will have many components, but an early priority for ASCO is to provide an electronic version of the Quality Oncology Practice Initiative that will provide support at the point of clinical decision making, improving quality prospectively and in real time. Clinical decision support systems will be based not only on guidelines taken from systematic review of published literature, but also on the rapidly developing molecular science of tumor biology and on health care systems data on outcomes and operational efficiencies.

Conclusion In a relatively short period of time, ASCO has recognized and anticipated the emergence of HIT as a transformative force that will drive innovation in cancer care. Table 1 summarizes the current objectives that underlie the Society’s work with HIT. Enactment of CancerLinQ will require not only technical improvements in data quality and transmission, but also successfully addressing a host of regulatory and ethical concerns while at the same time providing immediate value to patients and families, health care providers, and society. ASCO vision is Table 1. ASCO’s HIT Objectives Guide the selection and optimization of HIT in cancer care and research. Foster the development of standards for the use and sharing of cancer data. Guide industry on development of functionality that best supports oncology. Create a digital health enterprise for oncology based on RLS design. Abbreviations: HIT, health information technology; RLS, rapid health care learning system.



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that by the intelligent and creative development of HIT, such as CancerLinQ, HIT will become as much a part of our cancer armamentarium as diagnostic testing, therapeutic interventions, and compassionate care are today. Author’s Disclosures of Potential Conflicts of Interest The author indicated no potential conflicts of interest.

Corresponding author: Peter Paul Yu, MD, 795 El Camino Real, Hematology-Oncology SV 301, Palo Alto, CA 94301; e-mail: [email protected].

DOI: 10.1200/JOP.2014.001467; published online ahead of print at jop.ascopubs.org on June 24, 2014.

References 1. American Society of Clinical Oncology: Ensuring Continuity of Care for Patients With Cancer Through Electronic Health Records: Recommendations From ASCO’s 2007 EHR Roundtable. http://www.asco.org/sites/default/files/oct_2007_-_ asco_recommendations_from_ehr_roundtable.pdf 2. Shulman LN, Miller, RS, Ambinder ER, et al: Principles of safe practice using an oncology EHR system for chemotherapy ordering, preparation and administration. Part 1 of 2. J Oncol Pract 4:203-206, 2008 3. Shulman LN, Miller, RS, Ambinder ER, et al: Principles of safe practice using an oncology EHR system for chemotherapy ordering, preparation and administration. Part 2 of 2. J Oncol Pract 4:254-257, 2008 4. American Society of Clinical Oncology: CORE White Paper: More Details. http://www.asco.org/practice-research/core-white-paper-more-details 5. The Certification Committee for Health Information Technology: CCHIT Certified

2011 Oncology EHR Certification Criteria May 17, 2011. https://www.cchit.org/ documents/18/158304/CCHIT⫹Certified⫹2011⫹Oncology⫹Criteria.pdf 6. Center for Medicare and Medicaid Services, HER Incentive Program: Active Registrations. http://www.cms.gov/Regulations-and-Guidance/Legislation/ EHRIncentivePrograms/Downloads/February2014_SummaryReport.pdf 7. American Society of Clinical Oncology: Recommended HIT Standards and Policy Positions: Working With Government Policies and Regulations. http://www.asco.org/ practice-research/recommended-hit-standards-and-policy-positions 8. College of American Pathologists: CAP eCC. http://www.cap.org/apps/docs/ snomed/documents/about_cap_ecc.pdf 9. Institute of Medicine: Roundtable on Value & Science-Driven Health Care. http://iom.edu/Activities/Quality/VSRT.aspx

Cancer.Net: A Trusted Resource for Your Patients Cancer.Net (www.cancer.net) brings the expertise and resources of ASCO to people living with cancer and those who care for and about them. By providing timely, comprehensive information, Cancer.Net helps patients and families make informed health care decisions. All content is subject to a formal peer-review process by the Cancer.Net Editorial Board. Cancer.Net is supported by the Conquer Cancer Foundation. For more information, visit cancer.net.

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