http://connection.asco.org RSS feeds for ASCO Connection – professional networking for ASCO’s worldwide oncology community 60 http://connection.asco.org/Commentary/Article/ID/3524/Value-Is-in-the-Eye-of-the-Beholder.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3524 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3524&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3524/Value-Is-in-the-Eye-of-the-Beholder.aspx "Value-Based Medicine," if not yet a term for the ages, is an increasingly embraced concept for our times of diminishing health care resources, a time for doing more with less. The risks of not taking this reality seriously are borne out by Sequestration, another newly coined term in our vocabulary, and a warning that the failure of public discourse to find solutions to difficult economic and political problems leaves no one unscathed. Value-Based Medicine, in turn, has spawned a new category of research, Comparative Effectiveness Research, designed to provide an evidentiary basis for practicing less costly health care. But "Value" does not exist solely in terms of dollars and cents. Oncologists know better than most physicians that how one patient values a therapeutic option will differ from the next patient, and that even the same patient will evolve their perception of value along their cancer journey as they develop awareness of the cancer system and what cancer treatment entails. The words that speak to this are Patient Preferences and Shared Decision Making. Value-Based Medicine must accommodate flexibility in how individuals determine value, and the health care team must learn how to better frame the discussion so that patient preferences can be identified and articulated. We do ourselves a disservice when we speak of a statistically positive study of a new drug where the survival benefit could be measured in days. To that point, I am reminded of a conference where James Holland challenged Mort Coleman on the lack of clinical significance of a study result that nevertheless achieved its statistical target. When Dr. Coleman called on Dr. Holland to define clinical significance, his reply was, and I paraphrase, “Mort, you don’t go to every lymphoma conference, that’s statistically significant, but it’s always clinically significant when you do.” Once again ahead of his time. Within ASCO, we have started a dialogue on what comprises Value. This was one of the three topics debated by the ASCO Board of Directors at our annual March strategic planning meeting. ASCO’s Value in Cancer Care Task Force will take on the question of what is a meaningful response from the perspective of the patient. With the American Academy of Hospice and Palliative Medicine, we are positioned to study how the values and preferences of patients and families change as care becomes increasingly futile. ASCO is preparing a second “Top Five” list of medical tests or interventions that have little added value in oncology care as part of the American Board of Internal Medicine Foundation effort to encourage disciplined use of resources across medical specialties. But Value is not only about what we should or should not do. It is also about how we deliver healthcare, how operationally “Lean” we are, to draw upon yet another coin of the realm.  The value-based decision on the relative merits among different choices of chemotherapy unlocks only a part of the value proposition. There is value to be gained by driving efficiency in the delivery of care, patient centric value that reduces patient wait time, increases throughput in the infusion suite, and liberates staff to spend their time performing “Value-Added” work that improves the patient experience. Value Stream Mapping, Gimba Walks, Rapid Process Improvement Workshops, Change Management. . . the lexicon goes on. For oncology practices, operational efficiency is where we have the most control over our own resource allocation and in a world of bundled payments where a key component of practice survivorship exists. ASCO’s Public Policy develops from our understanding of what is best for patients and necessary for sustaining the delivery of equitable cancer care and the pursuit of cancer research. Fostering a dialogue within the ASCO community of what value means to patients, providers, and health care systems will help shape the message we bring to the larger national debate on health care reform.     Peter Yu, MD Sat, 27 Apr 2013 18:58:17 GMT f1397696-738c-4295-afcd-943feb885714:3524 http://connection.asco.org/Commentary/Article/ID/3426/Ethics-and-Health-Information-Technology.aspx#Comments 1 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3426 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3426&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3426/Ethics-and-Health-Information-Technology.aspx Recently I was asked to think about the ethical aspects of health information technology (HIT), which I confess, is not a subject I had given much thought to before. After all, what could be unethical about such an obvious example of manifest destiny? Of course, it turns out there are now a few ethical issues related to HIT and associated risks for unethical behavior, and I subsequently decided to examine the issue from the traditional ethical perspectives of beneficence, avoidance of malfeasance, autonomy, and justice. Unfortunately, those interested in hearing further will need to wait for the 2013 ASCO Annual Meeting Educational Session. But, I will offer three observations that seem to me to be unique and whose impact I am still pondering. The first is the validity of the separation of clinical research and routine clinical care. Most of biomedical ethics that resides in the consciousness of oncologists relates to our training in the conduct of clinical trials, and particularly with obtaining informed consent. Routine clinical care that is not part of a clinical trial does not have active oversight for ethical behavior and generally is assumed to be ethical if it follows standards of care. However, this bright line of distinction may be blurred by newer clinical research activities such as comparative effectiveness research and by data mining. Second, the increasing knowledge about patient genetic material, even to the extent of whole gene sequencing, complicates the de-identification of patient data, which is one of the foundations upon which data aggregation without obtaining patient consent is based. The HIPAA Privacy Rule regarding research is based on presumption that de-identification can be achieved at a level where it is statistically unlikely that the patient can be re-identified. Third is the concept of data ownership—and whether we should forgo it and substitute it instead with a more limited concept of data rights. Ownership seems to imply sole possession of an object as well as control over that possession. Health data that resides in a large data farm accessible only though proprietary software does not seem to be something that a patient owns. Electronic Health Records can easily cost $100,000,000 plus the expense of health care providers to document and enter that data, a cost that the patient did not bear. Although raw data has intrinsic value, that value is not realized without significant investment of time and effort that will increasingly be dependent upon machine learning such as IBM's Watson or ASCO's CancerLinQ™. The world as it now exists has not yet established ethical constraints on the aggregation, use, and monetization of health information. I would argue that the sooner we begin a dialogue on these three issues the better off we will be. Otherwise, we risk slowing the pace by which rapid learning can transform healthcare, once these issues surface on their own volition. Peter Yu, MD Mon, 28 Jan 2013 02:02:01 GMT f1397696-738c-4295-afcd-943feb885714:3426 http://connection.asco.org/Commentary/Article/ID/3330/Documenting-the-Cancer-Journey.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3330 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3330&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3330/Documenting-the-Cancer-Journey.aspx It is hurricane season once again and it has been 7 years since Katrina wreaked havoc on the Gulf Coast, displacing thousands of patients with cancer, many under active treatment. Since that time the world has changed, but the problems of coordination and continuity of care exposed by the Katrina displacement remain. In the aftermath of that disaster, ASCO conceived the Cancer Treatment and Summary Plan documents as a critical tool to assist in communication between providers and patients. Since that time, other versions of the same concept have arisen, originating from ONS and several patient advocacy groups, attesting to the validity of this need. Yet uptake has been poor. The constraints of paper documents are part of the problem. Since they are static documents of a patient experience that is still continuing to evolve, the data transmitted may be out of date. The paper format restricts how and what information is presented to the user; one size must fit all. The amount of work required to collect and enter data is considerable and the source of the data may not be identified calling into question the accuracy of that data. Ideally the documents must ensure that the data comes from an identified trusted source, state the time of document creation, and have flexibility to present the data differently as best meets the need of different audiences. Another factor limiting the adoption of summary documents in practice is that there is no convenient way to share or store the documents. Printing and scanning documents or exchanging PDF documents does not allow the degree of interoperability needed. Electronic health record vendors lack standards to work within formatting and messaging these documents. HL7 is the standard setting organization for exchange of patient health information. Last month, HL7 accepted ASCO's request for a new document template for cancer data. This allows ASCO to proceed with the design of a document that will be voted upon by the HL7 community and, if accepted, become the industry standard for the capture and exchange of a cancer patient’s health data. Because this template will be built upon the HL7 Common Data Architecture (CDA) model, it will allow data that is stored in XML format to be imported. This will enrich the number of identifiable sources of data, such as pathology and imaging reports or patient-reported data. What will be required is that each organization identifies what types of information it wishes to collect and share that data in XML format. Already, the College of American Pathologists is developing digital models for pathology reports. This document can drive clinical decision support and improve cancer patient survivorship. For example, if the document records that the patient is on an aromatase inhibitor and the date of the last bone density test, an alert can be sent that notifies the exact date that the next bone density test will be due. Because these documents are not limited to a point in time such as the start or end of treatment, a better name than Treatment Plan and Summary documents is needed. For now, a Cancer Patient Journey document may more accurately impart the essence. Finally, how and what data are presented to a particular type of user can be custom configured to that user through graphical user interfaces so that the documents best serve the needs of that audience. As we move from a paper to a digital world, we will need to reinvent old ideas and think outside of the box, be that paper or virtual. Peter Yu, MD Sat, 06 Oct 2012 21:39:24 GMT f1397696-738c-4295-afcd-943feb885714:3330 http://connection.asco.org/Commentary/Article/ID/3224/Healing-Sores.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3224 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3224&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3224/Healing-Sores.aspx The human aspects of cancer care and the belief that it is within our power to alleviate suffering and provide succor, while advancing towards a cure, is what drives us each day to do what needs to be done. It is the connection to humanity that transcends and transforms health information technology. Recently, Eric Vinson, a Cherokee Indian working at the Northwest Tribal Comprehensive Cancer Program, contacted me to learn what resources the American Society of Clinical Oncology Health Information Technology Work Group had to support cancer survivors among the American Indian and Alaskan Native populations. It brought back to me the experiences I had in medical school when I worked for a month at a remote Indian Health Service site in the Four Corners region of Arizona that cared for the Hopi Tribe and Navajo Nation. One night a pregnant woman in labor was showing signs of fetal distress. A decision was made to risk an emergency flight to the regional hospital in Tuba City and the pilot was called out. We took off in darkness from a dirt airfield in a propeller plane and when we landed it was the opening scene from MASH, with nurses running out onto the tarmac with a gurney. The baby delivered about 60 seconds after landing. One can see how Native Americans who receive their care at a cancer center far from their home will have difficulty obtaining survivorship care when they return home. Discussing this with Eric, I became aware of the semantic meaning of the word “cancer” in the Navajo language: “Beginning in the Fall of 2006, Navajo Cancer Glossary 'working group' meetings were held on nearly a monthly basis at the Shiprock, New Mexico, campus of Diné College. The original thinking was that this resource would be focused for use among the Navajo public, but participating Navajo professionals advocated that a resource of this nature was also critically needed by clinicians and educators due to the facts that: (a) there had never been a standardization and codification of cancer terminology in the Navajo language, and further that (b) existing commonly used translations in the Navajo language, which had become entrenched after decades of use, were both inaccurate and misleading. The most notable example is that the most commonly used translation in Navajo for “cancer” is [óód doo nádziihii or “the sore that does not heal.” This is not only technically inaccurate but it also tends to defeat the goals of screening and early detection and treatment, and tends to foster a fatalistic attitude that nothing can be done for the Navajo patient diagnosed with cancer." The power of language is a skill we believe unique to humans and is culturally embedded with meaning that reflects societal concepts and values. Somehow, that richness needs to be preserved when we transform language into digital code. Last week, I had the opportunity to speak with a group of Chinese volunteers for the American Cancer Society (ACS) Chinese Unit. These volunteers form a unique unit within ACS, the only one dedicated to an ethnic community, as opposed to a community defined by geography. The vegetarian lunch was provided by the Tzu Chi Foundation, a Buddhist organization dedicated to health care, charity, education, and respect for culture. Curious about this group, I went to their website to learn more about them and found the following parable about why bad things such as cancer happen to good people. During the Tang Dynasty (618-907 AD), a monk named Zhixuan came upon an older monk covered with non-healing sores and with compassion, attended to him until he recovered. The ill monk, actually a deity in disguise, instructed Zhixaun to visit him on Jiulong Mountain should he ever need help. Zhixuan went on to become a monk so renown for his virtue that the Emperor Yizong proclaimed him the Imperial Dhama Master Wu-Da and presented him with a magnificent sandalwood throne. At that moment, Zhixuan experienced the arrogance of pride and stumbling against the throne, he developed a non-healing sore that inflicted great pain. Curiously, the sore was shaped like a human face. Traveling to Juilong Mountain, he was received by the monk he had helped many years earlier and was given treatment with healing waters. But before the sore was healed, it spoke explaining that the wound was retribution for a sin committed 10 lives earlier but not evoked until Zhixuan became vulnerable by lapsing into a non-virtuous state. Anticipating this day, the deity had intervened. Today is Pentecost Sunday in the Christian faith, the end of the Easter Season and 50 days after Passover. On this day the Holy Spirit gave the Apostles the gift of tongues, enabling them to speak such that all heard in their native languages and understood. The semantic meaning of cancer—sores that do not heal and sores that speak to reveal truths—and the power of communication across languages and cultural barriers—these cultural beliefs that span centuries and oceans—tell us something about the human side of communication and its primal importance to us. So how do I connect this to health care and informatics? Of the five overarching goals of Meaningful Use, the most transformative is the Engagement of Patients and Families. Communication in a culturally sensitive manner that respects patient preferences and values forms the basis for a cancer journey that follows the best possible trajectory. The proposed Stage 2 Meaningful Use criteria includes one that requires 10% of patients to use the electronic health record to review test results or to communicate with their provider. Yet most of organized medicine has written to CMS asking to have this criteria removed on the grounds that physicians and other providers should not be made responsible for the actions or lack thereof of their patients. If we once again fail to accept our role as leaders, teachers and guides to our patients, we once again relinquish a piece of our moral high ground for the sake of short-term advantage. It is shortsighted to oppose this; 10% is a low bar to jump over. Meaningful Use is not a meaningless government mandate without purpose. We risk ending up where we will not want to be if we fail to keep focus on where our destination lies.] Peter Yu, MD Sun, 27 May 2012 22:15:25 GMT f1397696-738c-4295-afcd-943feb885714:3224 http://connection.asco.org/Commentary/Article/ID/3188/Silicon-Valley.aspx#Comments 3 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3188 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3188&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3188/Silicon-Valley.aspx It seems that every nephew or niece of mine who has an engineering degree is busy creating the next killer app for a mobile device. Usually it starts with way cool technology, but comes up short in figuring out why enough users would want it or what a sustainable business model might be. On the other hand, when last week's headlines were about a couple of 20-year-olds and their 40 employees whose start up for a photo-sharing app was purchased for $1 billion dollars, it would be a brave soul that would dismiss any idea outright. Still, a successful app needs to be based on well-worked-out technology, a sustainable business model, and most important, meet the needs of the user with an easy to user experience. Yesterday though, I saw another way to develop really useful apps. Hackathons are events where developers meet to address an important problem in need of software solutions with the goal of creating on-the-spot breakthrough apps. In a variation of this, the initial event is devoted to developing concepts, and the coding occurs over the next several months before a second event, where apps are judged and prize money awarded. In a third accelerator phase, the app is put to the test in the real world. Participants in a recent hackathon were asked to address the health problem of nutritional deserts. Nutritional deserts are parts of the U.S. that lack access to fresh fruits and vegetables or other high nutritional content food. The U.S. government has mapped such areas and made this information publicly available. The winning idea was an app that allows nutritional desert residents to use their smartphones to place an order for groceries that are aggregated by a distributor. The distributor tells the residents what location, day, and time they will bring their groceries. Residents improve their health through better nutrition, and distributors are able to sell their inventory in three hours without the unsustainable overhead of maintaining a grocery store. A commercial venture based on this is now operational. The Palo Alto Medical Foundation held a hackathon this weekend where the objective was creative solutions in caring for an aging population. The session began with three presentations to frame the problem for the developers, who generally have little medical background. Paul Tang, Chair of the Meaningful Use Workgroup for HHS, presented the global problem of an increasing elderly population and the need to build a social network/village of family, friends, health care providers, and public and private organizations to combat a patient’s perception of isolation, which leads to deteriorating health status. Todd Park, the newly installed U.S. Chief Technology Officer for HHS discussed the government’s objective of making its vast database of health information available to developers with the data machine ready and accessible through application programming interfaces (API). Finally, Eric Dishman, Intel’s executive responsible for Intel’s global strategy, research, and policy initiatives in health care spoke of Intel’s efforts to create mobile technology that helps to keep an elderly person with deteriorating functional level in their home and out of an institution. Developers then spent the rest of the weekend developing story boards and concepts. Three months from now they will re-convene to present their ideas and a panel will select the best concept. That app will be tested at the Palo Alto Medical Foundation to help accelerate its development and adaptation. One of the underlying concepts driving this hackathon was attributable to Bill Joy, a co-founder of Sun Microsystems, who said that “the smartest people don’t work for you.” They are out there though and giving them access to your ideas, data, and needs is the best way to get them to work independently to your benefit. The natural tendency for health systems is to jealously guard their data, having invested considerable sums in the acquisition and storage of that data. Perhaps the real value of that data cannot be realized without the willingness to share it. Peter Yu, MD Mon, 16 Apr 2012 04:15:08 GMT f1397696-738c-4295-afcd-943feb885714:3188 http://connection.asco.org/Commentary/Article/ID/3167/Is-Health-Information-Technology-a-Driving-Force-for-Change-or-Merely-an-Enabler-of-Change.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3167 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3167&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3167/Is-Health-Information-Technology-a-Driving-Force-for-Change-or-Merely-an-Enabler-of-Change.aspx In health care, we often find ourselves reacting to events rather than dictating them. Being cast in this undesirable position is often unavoidable when dealing with regulators and federal policy. However, the ability to foresee the need for change and thereby influence the direction of change is a mark of solid leadership. ASCO recently surveyed volunteer members who hold leadership committee positions on what are the three greatest driving forces that will shape how oncology looks a decade from now. The three most mentioned were genomics, affordability of care (cost and value), and Health Information Technology (HIT). Some, however, questioned whether HIT is truly a driver or merely an enabler, and whether ASCO’s strategic thinking should include HIT as a central driving force for change. I would argue that HIT has become a driver for the following reasons: Federal health care policymakers have learned that influencing HIT can be a powerful force for resetting health care priorities and physician roles through reimbursement incentives or penalties. CMS now directly dictates the software development priorities of HIT vendors and the use of EHRs by hospitals and providers. The FDA is studying how to leverage the growing installed base of EHRs to accelerate drug evaluation and approval. As a result, how HIT is implemented will drive how health care looks. The ASCO Board recognizes the need for professional societies to be a part of this discussion and to guide both federal policy and software development. Equally transformative is the understanding among federal agencies that engaging end users of HIT is critical to the successful transformation of health care and this has created a more balanced dialogue between federal policymakers and clinicians. Unleashing the power of molecular data to help prevent and treat cancer will require the ability to capture complex, changing, high-volume data and to correlate molecular data with patient phenotypic and behavioral data. This was not possible before EHRs, is still not possible given current EHRs, but will be a driving force as we struggle to achieve the ideal of personalized, precision medicine. HIT is a competitive advantage for organizations. I hasten to add that the data have little value in this sense, absent the ability to aggregate, analyze, and act upon such data. To be able to obtain research-quality data out of routine patient care records will require organizational strength in operations, finance, and human resources on a scale that large health care delivery systems alone possess. HIT will therefore be a driver in defining the types of relationships that physicians establish as they build their networks and ecosystems. Consumer expectations of HIT will establish new relationships with their health care providers. These expectations will be difficult to meet, given the complexity and uniqueness of cancer care compared to not only routine health maintenance, but say, managing a social network. Nevertheless, we will be challenged to meet these expectations in ways that are novel and best serve health care needs. Ultimately, I think that the most potent driver of change in oncology will be cost. In the United States, we have a health care delivery system that is unaffordable and at the same time we have an inefficient cancer research system that is equally unaffordable, with its own unaddressed and poorly articulated access to care problems. I would advance the concept that we need one system where clinical care and research are blended together, a system where the quality of health data improves to the point where it can be used for clinical research. This will require a system where the expectations for clinicians to follow evidence-based medicine are strengthened and where the academic community becomes more flexible in accepting a wider range of outcomes data that are more relevant to patient- and practicing physician–concerns. This transformation will only be possible through the thoughtful re-engineering of health care through HIT. Peter Yu, MD Sun, 11 Mar 2012 23:50:30 GMT f1397696-738c-4295-afcd-943feb885714:3167 http://connection.asco.org/Commentary/Article/ID/3077/FDA-Bevacizumab-Decision.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3077 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3077&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3077/FDA-Bevacizumab-Decision.aspx This week the FDA decided to withdraw bevacizumab's indication for treatment of metastatic breast cancer. The earlier indication had been approved under FDA's accelerated approval process wherein final approval was conditional on the generation of confirmatory evidence based on clinical trials. Such trials did not show the expected benefit leading to the rendering of the controversial decision to withdraw the FDA indication.  Between the initial accelerated approval and this week's decision, practice patterns had been set using bevacizumab in the routine care of breast cancer patients with metastatic disease and a strong clinical impression was left on many patients and practitioners that at least a subgroup of this population did derive clinical benefit.The FDA accelerated approval policy stems from a laudable desire to speed cancer patients' access to new therapies. It goes hand in hand with the CMS policy of "Coverage with Evidence Development," or CED, that allows provisional reimbursement for new drugs pending further supporting evidence development, but unlike the FDA policy, CED also provides for a mechanism to acquire that evidence through mandatory reporting of outcomes to a registry. This is a more rapid manner to fill the knowledge gap than depending on the completion of randomized clinical trials.A third federal initiative that might speed up evidence generation and that holds great potential to better inform drug approval and reimbursement policy is the FDA mini-Sentinel Program. The mini-Sentinel Program now tracks data on 100 million patient lives through those patients' electronic health records (EHRs). These are patients who receive care at integrated health care delivery systems that use a variety of EHR vendors, but who have agreed to use a distributed data network system to answer queries about patient data and medication use to evaluate for adverse events and potentially confounding factors. Presently, the focus is on drugs that have already obtained FDA full approval, but eventually, such a system could be used for comparative effectiveness research and earlier in the drug approval process.Together such initiatives as FDA's accelerated approval, CMS' coverage with evidence development, and FDA's mini-Sentinel Program may, if combined, lead to a more rapid and learning health care system that allows patients access to new treatments without exposing those same patients to excessive risk for adverse events or the health care system to costly, wasted expense. ESAs and bevacizumab had biologically plausible stories with enticing clinical benefits, but that is not sufficient. Peter Yu, MD Sun, 20 Nov 2011 23:23:11 GMT f1397696-738c-4295-afcd-943feb885714:3077 http://connection.asco.org/Commentary/Article/ID/3072/IOM-Envisioning-a-Transformed-Clinical-Trials-Enterprise-in-the-United-States.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3072 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3072&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3072/IOM-Envisioning-a-Transformed-Clinical-Trials-Enterprise-in-the-United-States.aspx This week the Institute of Medicine held a workshop on “Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020.” During the 2-day meeting a variety of underlying themes were presented, none more transformative than that presented by Robert Califf, Vice Chancellor for Clinical Research, Duke University and Editor-in-Chief of the American Heart Journal. Dr. Califf posed that a central flaw in the United States clinical trials enterprise (CTE) is that we have allowed the health care delivery system to evolve distinct from the CTE. Today, the two largely function independent of each other. I would suggest that this is the result of yet another split, between academic and community medicine. Although the benefits of NCI programs such as the Cooperative Groups and CCOPs, combined with the unique history of oncology and its dependence on pharmacologic-based research have mitigated the negative impact upon oncology compared with other fields of medicine, we have not escaped from this untouched. The untoward consequences of this dichotomy include: Patients and providers perceive clinical research as "optional," experimental and in a less favorable light than standard care options, not withstanding the often very limited benefits of standard therapies. The goals of clinical trials often reflect the interests of the academic-based researcher rather than the interests of patients and community oncologists, resulting in complex, multi-arm trials with several internal randomization steps that are hard to explain and understand. Fifty percent of clinical trials that are opened never accrue a single patient and across medicine, 85% of trials are considered failures. Insurers do not routinely cover clinical research costs, since research trials are considered to be distinct from routine care instead of being built into the reimbursement system. Construction of costly, redundant and parallel systems for operational functions such as billing, contracting and medical record documentation. The loss of a quality improvement benefit that results from conducting clinical trials with their required attention to detail and audits where unrecognized system errors can be identified. Clinical trial protocols often seemed designed to generate audit problems, since the protocol procedures often deviate significantly from routine care workflows. The lack of commitment to research across the spectrum of medicine negatively impacts the conduct of research. Imaging comes to mind. By segregating the CTE from routine care, patient selection bias is introduced, which is one reason for the need for clinical effectiveness research. The adoption of clinical trial findings into routine clinical practice is slowed by a supply side process wherein the findings are pushed out to clinical practice instead of a demand side process with greater involvement by patients and providers in designing clinical trial questions so that the results are pulled in by the end users of that knowledge. A potential path towards convergence of the CTE and health care delivery systems may be the Meaningful Use (MU) program. The federal government has made it quite clear what it considers the primary goals of the nation’s health care delivery system should be: the five overarching goals delineated by the IOM and adopted by ONC for MU. Conspicuously, supporting the CTE is not one of those goals. The message is clear; the CTE must cast itself as part of the MU objectives or else continue to remain apart, with all of the negative consequences outlined above. Research by itself is not a goal. The value of research in the real world is as a mechanism to achieving improved health and economic outcomes. Reform of the United States health care delivery system is upon us and presents an unprecedented opportunity to recast the CTE as a vital and sustainable part of a new health care delivery system. To do otherwise is to condemn our future to our past. Peter Yu, MD Thu, 10 Nov 2011 06:32:50 GMT f1397696-738c-4295-afcd-943feb885714:3072 http://connection.asco.org/Commentary/Article/ID/3069/ASCO-HITEHR-Symposium-Day-2.aspx#Comments 1 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3069 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3069&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3069/ASCO-HITEHR-Symposium-Day-2.aspx Let me start by mentioning 2 things I missed earlier about Day 1 of the ASCO HIT/EHRs Symposium.  In the session on Usability, Karen Bell, Chair of CCHIT, mentioned 3 areas where EHRs may impact malpractice risk; Communications, Documentation and Medical Errors. Each of these has the potential to increase the risk of litigation if neglected. Communications within a practice team, with external providers or with patients can all be facilitated by EHRs, but communicating poorly or not at all is a recipe for trouble.  The Meaningful Use goals of interoperability, care coordination, and patient and family engagement in shared decision making revolve around the capabilities of EHRs to improve communications. It is a requirement that EHRs documentation includes tracking provider actions with a time stamp.  Who saw what and what they did or did not do about it, is all recorded and discoverable information.  And any diagnostic or treatment errors are there for the looking.  There is ongoing debate within usability circles as to the best practices to address these aspects of usability which will deserve close attention.Also on Day 1, Chuck Friedman brought up the topic of Ultra Large Systems, a concept originally introduced by the Department of Defense that views knowledge sourced from digital information as a strategic weapon (and before you react to that, remember who brought us the internet).  The DOD sees the battlefield of the future as littered with multiple information and weapon systems, some, legacy, some cutting edge, and all subject to catastrophic system failure.  Communications between front line troops and battlefield command may be lost or sporadic. Retaining operational command and winning the battle while wrapped in this fog of war is the goal of Ultra Large System theory. In such situations, the traditional features of information system design such as fail safe, disaster recovery and standardization of systems are just not feasible and when systems reach a tipping point in size, the system design must take this into consideration  The parallels with our large, fragmented healthcare delivery system have been recognized by the IOM.Day 2 included sessions by many of the ASCO HIT WG members.  Mia Levy and Kevin Hughes shared a session presenting new apps developed at Vanderbilt and MGH to assist in using genomic information for treatment decisions and to assist is surgical office workflows, respectively.  John Cox chaired a session on new practice models looking at the oncology patient centered home and pathways for chemotherapy prescribing.  Larry Shulman moderated a session on quality improvement through HIT.If nothing else, the ASCO HIT/EHRs Symposium has made it very clear that HIT in 2011 already encompasses much more than replacing a paper chart with a digital version.  It is about redesign of the international health care delivery systems, speeding knowledge generation, quality improvement and improving shared decision making with patients.  Unlike today, when day light saving went into play, we are not going to be able to turn back the clocks on the adoption of HIT. Peter Yu, MD Sun, 06 Nov 2011 22:21:49 GMT f1397696-738c-4295-afcd-943feb885714:3069 http://connection.asco.org/Commentary/Article/ID/3067/Generic-Drug-Shortage.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3067 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3067&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3067/Generic-Drug-Shortage.aspx The November 3rd edition of the NEJM features a Perspective article on drug shortages by Mandy Gatesman and Thomas J Smith (NEJM 365:18 page 163) that address many of the causative issues that underlie this growing national problem.  However in my opinion the single most important reason lies in the fundamental conflict that results from having some parts of the healthcare system subject to intense regulation (providers and hospitals) and others allowed to operate in the open free market with comparatively little regulation.The problem dates back to a law that was passed about 10 years ago regulating how generic drugs come to market. Only now are we seeing the impact of that as drug patent life expires. When a drug patent expires, any manufacturer can enter the market and many do because the profit margins on these drugs are over 90%. However, the winners are the first three or so that enter the market. The late comers serve to drive the price down so low that none can make a profit. The bottom hits when the generic drug is priced at about 1% of the original price.  At that point the generic companies exit the market and go on to another generic drug that hasn't yet hit rock bottom. The manufacturing capacity for generic drugs is limited. Compounding this problem is that injectable drugs are much more difficult to make than oral drugs and the overall market of oncology drugs is still small compared to say Lipitor. The Medicare Modernization Act pegged drug payments to oncologists at a figure that is 6% higher than the Average Sales Price (ASP). ASP is not what it appears to be. ASP is the price that manufacturers report to CMS each quarter on what they were paid by wholesalers. The wholesalers add their profit margin and that reduces the 6% margin the oncologist has above the manufacturer's price.  When you add in bad debt, outdating of drug before use, wastage due to cancelled treatments and the like,  an oncologist is quickly under water. The group of 12, the 12 Congressional members charged with coming up with a plan to reduce the federal debt by $1 trillion by later this month are considering reducing oncologists reimbursement to ASP +3% or lower. The problem is that while the free market allows the price of generic drugs to freely fall as new generic companies enter the market, the ASP+6% formula does not allow the opposite to happen; that is to allow the price to rise freely as supply dries up. The irony as the article states is that we are being penny wise and pound foolish. It would make sense to raise the margin on ASP for generic drugs.  Otherwise, oncologists cannot use cheap generic drugs and end up using very, very expensive brand drugs that are still on patent. Peter Yu, MD Sun, 06 Nov 2011 16:56:34 GMT f1397696-738c-4295-afcd-943feb885714:3067 http://connection.asco.org/Commentary/Article/ID/3066/ASCO-HITEHR-Symposium.aspx#Comments 1 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=3066 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=3066&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/3066/ASCO-HITEHR-Symposium.aspx Today was day 1 of the ASCO HIT/EHR Symposium, which covered a wide range of the ever changing HIT landscape.  Paul Tang, Vice Chair of the ONC HIT Policy Committee, and Chuck Friedman, former Chief Scientific Officer of ONC, now Director of Health Informatics at the U. Michigan School of Public Health and School of Information, led the day with a review of Meaningful Use and the underlying concepts of a Learning Health System.  In the 5 months since MU incentive dollars have started to flow, almost $1 billion have been qualified for and an estimated 20% of the nation's physicians and 50% of its hospitals have registered.  While most physicians are internists, 10% have been cardiologists, indicating that specialists are included.  Stage 2 criteria are expected to be put out for public comment by CMS within the next few weeks and ONC recommendations included Care Plans and Summary documents, one of ASCO's main goals for some time now.  It is anticipated that by 2019, 80% of health data will be digital. Anticipating that, next Monday, IOM is holding a workshop to discuss transformation of the  clinical trial enterprise and acceleration of drug development by 2020 through application of the Learning Health System and yesterday ASCO released its Blueprint Document on setting directions for clinical trial based research over the rest of this decade.  To get there will require extensive build out of information exchanges capability and bi-directional information flow, most likely by a federated distributed data network model that will link knowledge bases such as EHRs, SEER, state tumor registrars, ASCO, Pharma, and Cancer Centers, among others.  The topic of data exchange was the focus of sessions on state Health Information Exchanges by the former Georgia Cancer Coalition (a project now taken over by Georgia Tech) and from Marc Overhage of the Regenstreif Institute/Seimens, and on Data sharing between molecular based labs and EHRs by Larry Shulman (DFCI, ASCO HIT WG) and David Fenstermacher of the Moffitt Cancer Center. Other sessions were led by ASCO HIT WG members, Marilou Terpenning, Edward Ambinder, John Krauss, and Robert Miller spoke to ACOs, Social Media and the Vendor Challenge demonstration.A fascinating collection of HIT experts and a wonderful survey of what the future holds for the practice of oncology and improving treatments for cancer.Wish you were all here. Peter Yu, MD Fri, 04 Nov 2011 21:57:22 GMT f1397696-738c-4295-afcd-943feb885714:3066 http://connection.asco.org/Commentary/Article/ID/2935/Slow-Food-Fast-Food-or-Perhaps-a-Bit-of-Both.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=2935 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=2935&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/2935/Slow-Food-Fast-Food-or-Perhaps-a-Bit-of-Both.aspx The ASCO Board has embraced the concept of the Rapid Learning Health Care System (RLHS), the vision of a national digital health information system that enables sharing of data between individual health care providers and patients as well as populations of healthy individuals who are at identifiable high risk of disease. Much of the energy and resources of the Society will be devoted toward building out the knowledge bases, apps, and social networking capabilities that will breathe life and give shape to this new model where information exchange and decision making occur at a pace commensurate with the digitally connected society that we live in today.How does one relate an RLHS to the slow, deliberate pace of translational and clinical trials-based research and to the Society’s core values and culture?  Notwithstanding the NCI’s Clinical Trials Working Group blueprint to improve the efficiency of the clinical trials enterprise, translational and clinical trials research must be conducted in a slower scientifically rigorous manner that emphasizes high-quality data in well-defined cohorts of patients that are narrowly structured to allow precision and clarity to be hallmarks of study findings. The research conducted by cancer centers, cooperative groups, and pharmaceutical industry are essential and form the knowledge base bedrock of the RLHS.The RLHS is largely, although not solely, about the dissemination and application of clinical trials generated knowledge into health care delivery systems in the most efficient, optimized manner.  For example, we need to understand how best to replicate clinical trial findings in the real world where patients are not subject to exclusion criteria and instead fully reflect a spectrum of comorbidities, receiving care in health care delivery settings that differ from university clinics. We need to ensure that complex, ever expanding knowledge bases such as genomics and proteomics biomarkers that provide critical guidance for selection of therapies are applied to individual patients at the points of care and decision making. The RLHS is democratic, allowing patients and families to participate in knowledge generation through patient-reported outcomes data and providing guidance about health-related areas of research that are of the most interest to them. Quality affordable cancer care leading to improved outcomes is a core value of ASCO and its members that is enhanced by an RLHS.The knowledge derived from an RLHS should not be considered scientifically unsound because it is not based on randomized controlled trials. Rather scientifically sound research techniques from the social sciences will be applicable here, approaches to learning that we are not well-versed in. The fusion of translational and clinical trials research with  research using the approaches of economics, health care policy, and systems research, and infused with a new source of primary data arising from all patients and all ASCO members collected through a national digital health information infrastructure, is a transformational leap forward. We must not let our fear of disruptive change prevent the cultural change that is necessary within our Society to succeed in building the Rapid Learning Oncology Care System. Peter Yu, MD Tue, 07 Jun 2011 05:35:44 GMT f1397696-738c-4295-afcd-943feb885714:2935 http://connection.asco.org/Commentary/Article/ID/2763/Reflections-on-the-Meaning-of-Value-in-Health-Care.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=2763 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=2763&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/2763/Reflections-on-the-Meaning-of-Value-in-Health-Care.aspx A recent copy of The New England Journal of Medicine leads with an editorial from Michael E. Porter, PhD, of the Harvard Business School, entitled “What Is Value in Health Care?” It is a thoughtful perspective on how we physicians, ultimately responsible for improving our patients' health and well being, need to rethink the manner in which we take measurement of ourselves. The article is well worth reading, and I recommend it so that you may formulate your own thoughts, but here are some reflections I’d like to share. Porter starts with the commonly used definition of value as outcomes/cost, but explores with greater precision what outcomes and costs really mean. For complex diseases, no single outcome by itself can measure value, and he divides outcomes into three tiers. The first tier for oncology encompasses survival, freedom from disease, and improved quality of life; metrics that we are all familiar with since these are standard ways of measuring outcomes in cancer clinical trials. The second tier of outcome measures evaluates efficiency and toxicities of care delivery, such as time to diagnosis and start of treatment, ineffective diagnostic steps or care and side effects of treatments such as emesis or febrile neutropenia. The third tier evaluates the sustainability of health and long-term consequences of treatment, what we think of as survivorship.   On the cost side, Porter emphasizes the need to consider both the total cost of an episode of care as well as the longitudinal costs over time. This requires capturing the costs across multiple medical specialties and care delivery settings. Integrated health care delivery systems or their less efficient surrogate, accountable care organizations, rise to the occasion here. It is hard for me to see how we will achieve value in health care without learning how to integrate both information systems and providers across the spectrum of patient care. Porter writes, “The current organizational structure and information systems of health care delivery make it challenging to measure (and deliver) value. Thus, most providers fail to do so. Providers tend to measure only what they directly control in a particular intervention and what is easily measured, rather than what matters for outcomes.”   Societies such as ASCO spend considerable time and effort writing evidence-based guidelines. Adherence rates to guidelines are an attractive way to measure quality, but because guideline adherence does not by itself guarantee improved outcomes, there is a danger in assuming that fidelity to guidelines is synonymous with quality care. Guidelines and QOPI measures typically address an aspect of process of care rather than an outcome measure. If a chain is only as strong as its weakest link, then we can only safely assume that process-of-care measurement evaluates quality improvement if we measure every step of a workflow process. Porter states, “There is no substitute for measuring actual outcomes, whose principal purpose is not comparing providers but enabling innovations in care. Without such a feedback loop, providers lack the requisite information for learning and improving.” A rapid learning healthcare system, where every patient’s experience is used to create knowledge, stimulate research, and inform health care is dependent on outcomes measurement.   Peter Yu, MD Fri, 31 Dec 2010 01:06:14 GMT f1397696-738c-4295-afcd-943feb885714:2763 http://connection.asco.org/Commentary/Article/ID/2708/Nobel-Memorial-Prize-in-Economic-Sciences.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=2708 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=2708&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/2708/Nobel-Memorial-Prize-in-Economic-Sciences.aspx A high school friend of mine grew up to be a Princeton economist, and every October when I read the New York Times article announcing this year’s winner of the Nobel Prize, I pay attention to see if this is the year that he makes the front page. Although last week’s announcement went to three other economists, it is interesting to see how economic theory impacts society in everyday life. The work of this years recipients, Peter Diamond, Dale Mortensen, and Christopher Pissarides, involved the study of matching labor markets with job opportunities. Prior to their work in the 1970s, it was widely assumed that the determining factor was the rise and fall of wages in response to the level of demand for labor. As wages adjusted to demand, the market would efficiently adjust employment levels. However, the reality is that inefficiencies exist in matching an employer with an employee. In part, the skill sets of job applicants differ, so that it is not a simple matter of all employers looking for the same skill set nor all applicants equally qualified. A similar situation arises in the housing market. Matching buyers with sellers is difficult because even at the same price point, no two houses are identical. The work of the 2010 Nobel Laureates helped found search theory. We face a similar need for advanced search and matching ability in order to realize the concept of personalized medicine that we all see coming. How can translational researchers most efficiently identify patients who match the genomic and proteinomic profiles that predict response to novel therapeutic approaches when we move beyond simple one-step targeted treatments? How will clinicians identify which trials hold the best promise of a positive response for their patients? Part of the complexity of this question is that the relevant matching data are not likely to be held or curated in one data base. For example, the gene expression profile may well be performed by a commercial laboratory and be too complex for an electronic record to house. Will we trust commercial entities to host this data and serve as a data node? The patient clinical data may be critical to link phenotype with genotype in order to personalize the approach to treatment; how do we match the data in an electronic medical record with data banks? In order to link the players in this ecosystem, we will need standard controlled vocabularies that are machine readable, data systems that are interoperable, and coordination of care to a degree that does not exist today. Yet that comes at a price. The more we require of health information systems, the more work and cost we will generate for the users of the system. Healthcare delivery systems that understand the need, allocate appropriate resources and educate their providers will in the end be more successful at personalizing health care. ASCO can, should, and will provide leadership in moving this forward, but in the end, personalized health care will be the result of a consensus for socio-technological adaptation. Peter Yu, MD Mon, 18 Oct 2010 00:07:30 GMT f1397696-738c-4295-afcd-943feb885714:2708 http://connection.asco.org/Commentary/Article/ID/2596/How-to-Design-a-Better-Camel.aspx#Comments 2 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=2596 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=2596&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/2596/How-to-Design-a-Better-Camel.aspx It’s said that a camel was the result when a committee got together to design a horse. Over the next two months, the Institute of Medicine and the Office of the National Coordinator for HIT (Health Information Technology) will convene 100 experts to debate and design what a national HIT infrastructure should look like, including the rules of engagement needed to support the ambitious goals of health care reform. Rather than taking on health care reform piecemeal, this will be an effort to take on all the different issues that individually seem unsolvable. Because the thorny and contentious issues are often closely intertwined, a global approach appears more likely to obtain a measure of success. Participants represented a diversity of perspectives and included patient groups such as the Armstrong Foundation; federal agencies such as FDA and CMS; standard-setting organizations such as NQF and CDISC; nonprofit public policy bodies such as the Brookings Institute, Rhode Island Quality Institute, and California Health Care Foundation; HIT-related organizations such as AMIA, Regenstrief Institute, and Health 2.0; and a variety of academic institutions and large medical groups. At the first session, held July 27-28, the tasks were divided into the following areas: Technical Infrastructure: Interoperability of data and knowledge creation through standards, grids, clouds, and distributed data networks Public engagement and Population Health: Cost transparency, personal health records, chronic disease management, and disparities in patient access to electronic information Weaving a trust fabric: Privacy, HIPAA, and system security Governance and Stewardship: Public acceptance, trust, and oversight International perspectives on HIT A Futurist’s view My first reaction as an oncologist being exposed to this remarkable display of the complexity of health care reform was akin to “we’re not in Kansas anymore.” My second reaction was that those of us who care for cancer patients will need to reexamine, rethink, and refresh all that we do, so that we retain a relevant voice in health care reform. We can accomplish that by turning outwards to recognize the legitimate concerns and goals of all others involved in healthcare. We will succeed if we are smart enough to position ourselves as a model for how specialty care can be a positive force for change and innovation. And perhaps most difficult, my fellow wizards, we will need to change our thinking so that we are less enamored of technical measures of quality and focus more on measures that patients can relate to. When I recently asked our breast surgeons for data elements they were interested in, they suggested mm of surgical margins, understandably important to the surgeon, but of uncertain relationship to ultimate patient outcomes. When I think about what my patients want to know, more likely, it is when they will be able to return to work after chemotherapy. The sad fact is that while I have some sense of that answer, I don’t collect that data and without that I don’t have a handle on how I might improve that outcome. Peter Yu, MD Mon, 16 Aug 2010 13:31:37 GMT f1397696-738c-4295-afcd-943feb885714:2596 http://connection.asco.org/Commentary/Article/ID/2597/Its-heating-up-this-summer-for-HIT.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=2597 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=2597&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/2597/Its-heating-up-this-summer-for-HIT.aspx In the last 48 hours, CMS released the final rules governing the first stage of MU and CCHIT launched its oncology workgroup. Things are heating up this July. The ARRA regulations for the incentive program for implementation of meaningful use of HIT were released as 3 documents. The one of greatest interest to oncologists is the Final Rule providing guidance to providers on what they neeed to do to qualfy for the incentive dollars ($44,000 over 5 years per eligible provider participating in Medicare). The other two regulatory documents address the requirements that EHR's will need to meet to be deemed certified for ARRA, and the process of testing and certifying such EHR systems. Most of the 864 page document provides detailed responses to the thousands of public comments that were submited. Compared to my past experiences reading CMS responses, these are unusually clear, thoughtful and transparent (it helped that I spent 10 out of the last 36 hours in airplanes). In numerous situations, the CMS assessment has lead to CMS accepting the validity of the public comment, reversing itself and making it much easier for providers to qualify for the incentives offered. The ARRA program is unlike any other that CMS has taken on and CMS has approached this with an open vision. I see this as a sign that CMS and ONC realize that a transformative event such as this will only occur if there is buy in on the part of providers and that a cultural change like this cannot be regulated into existance with a blunt instrument. For example, CMS has removed any requirements that would require a provider to manually go through paper records. Instead, the certified EHR must be able to generate the numerators, denominators and percentages, greatly easing the administrative burdens on practices to participate. The overall number of requirements has been greatly reduced. CMS accepted that the previous requirements were too rigid and self defeating in that too few providers would qualify. Consequently, the requirements have been split into 15 core measures that all must meet and 10 measures in a menu set where the provider may eliminate any 5 (as long as one remains that falls into the population and public health domain). Another feature of ARRA is the requirement that providers report on quality measures chosen from a list of National Quality Forum (NQF) endorsed measures. This reporting feature is one of the more novel features of ARRA and will require much development before it becomes robust and meaningful. It has been a sore point for me that the NQF endorsed measures have no measures that are relevant to oncology practice. CMS indicates that given the short time line and the manner in which ARRA legislation was written, priority was given to NQF measures, but that in the future stages of MU, speciality organizations will be consulted. I hope this means ASCO! However, CMS did reduce the required quality measures to six; three core measures and three discretionary measures. Furthermore, they eliminated the proposed requirement that an oncologist must use the three oncology NQF measures, one of which was not likely to apply to most medical oncologists (not ordering bone scans in favorable prognosis prostate cancer patients folowing up after surgical or radiation therapy of early stage disease). More important, CMS clarified that the only objective is demonstration that providers and systems report on these measure, not that they exceed a performance threshold. "Thus, the clinical quality measure requirement for 2011 and beginning in 2012 is a reporting requirement and not a requirement to meet any particular performance standard for the clinical quality measure, or to in all cases have patients that fall within the denominator of the measure". In other words, even if no such patients exist in a practice, the act of reporting that qualifies. The second big event of the week involves the Commission for Certification of HIT (CCHIT), which has two roles to play in this. First, CCHIT has submitted its application (500 pages!) to become a certifying body of EHRs under the temporary program that was set up for the first year of ARRA. Earlier this year CCHIT performed a gap analysis for several dozen systems that had previously been certified by CCHIT under its original comprehensive certification program that predates ARRA. It is thought that those systems will be among the first to achieve ARRA certification once CMS determines the certifying bodies, which CMS expects to occur later this summer. The bad news for oncologists is that none of the oncology specific EHR systems have prior CCHIT comprehensive certification since that certification program was designed for large, complex enterprise systems used by hospitals and large medical groups. The second CCHIT news was the launch of an oncology certification workgroup that met yesterday in Chicago. This group includes four medical oncologists, all members of the ASCO EHR WG; Drs. Larry Shulman, Nancy Sklarin and Robert Miller. I co-chair this WG with Dr. Pawan Goyal of Hewlet-Packard. The other 9 members represent radiation oncology, survivorship, the American Cancer Society, vendors, oncology nursing and the NCCCP program. Initially focusing on adult ambulatory oncology systems that are a part of enterprise EHRs, this group will also lay the groundwork to potentially develop certification for the stand alone ambulatory systems more commonly in use by oncologists. Finally, later this month the Institute of Medicine and ONC will co host the first of a series of workshops to help lay a groundwork for a national electonic health infrastucture that will go far beyond EHRs and encompass all of the elements needed to support health care reform that achieves improved quality and affordability. More on that in a couple of weeks.     Peter Yu 2 Aug 2010 5:56 PM     That is certainly true for oncology. A provider could easily implement a system that qualifies for the MU incentives and yet have a system that does little to improve oncology related office functions. The short term gain of the incentive dollars will be insufficient compensation for the misery of acquiring a system that was not designed for medical oncology.     vishal swamy 2 Aug 2010 5:26 PM     Nice post. Seem true on most accounts but I also think that today medical practitioners are looking to avail of this federal incentive by trying to comply with the definition of meaningful use but at the same time EHR providers are looking at their own set of profits. This misunderstanding is mostly I believe as a result of wrong interpretation of the federal guidelines. The EHR providers need to look at these guidelines from the prospective of the practitioners who deal with different specialties. Each specialty EHR has its own set of challenges or requirements which I believe is overlooked by in most EHR vendors in an effort to merely follows federal guidelines. This is resulting in low usability to the practitioners, thus less ROI, finally redundancy of the EHR solution in place. I think ROI is very important factor that should be duly considered when look achieve a 'meaning use' out of a EHR solution. Though one may get vendors providing 'meaning use' at a lower cost, their ROI / savings through the use of their EHR might be pretty low when compared to costlier initial investment. Found a pretty useful ROI tool that is pretty customizable and easy to use. It also accounts for the different specialty EHR's too. Also the introduction of REC’s through the HITECH act. is a great way to avail of quality EHR solutions at competitive prices. The stiff competition among not only these REC’s but also among EHR vendors ( to become a preferred vendor of a given REC) will result in lot of positives to medical practioners. Looking the funding provided to the REC’s, the staggered grant allocation system also promises to be an unbiased way of allocating funds. It will also help in the concept of REC’s helping out each with their own unique business models. It can be one of the possible answers to the 'safe vendor challenge' as discussed by many critics. Peter Yu, MD Fri, 16 Jul 2010 05:58:04 GMT f1397696-738c-4295-afcd-943feb885714:2597 http://connection.asco.org/Commentary/Article/ID/2598/Data-exchange-and-interoperability.aspx#Comments 0 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/RssComments.aspx?TabID=117&ModuleID=478&ArticleID=2598 http://connection.asco.org/DesktopModules/DnnForge%20-%20NewsArticles/Tracking/Trackback.aspx?ArticleID=2598&PortalID=0&TabID=117 http://connection.asco.org/Commentary/Article/ID/2598/Data-exchange-and-interoperability.aspx This past week, HHS announced that $386 million had been awarded to 40 states to form health information exchanges (HIE). HIE will be responsible for facilitating the transfer of medical information between providers. HIE's, although state based, may come together to form regional exchanges. This highlights one of the underpinnings of the Administrations's vision for health care reform as well as one of the greatest (hopefully not fatal) flaw in our current health care system. Health care is fragmented among different hospitals and providers such that common goverance, communication and shared policies do not exist. This generates quality problems and waste. One answer would be modeled on Kaiser Permanante or the VAH, where all of a patient's providers are under one organization and where all information is shared down to the last detail (do I need to know if my cancer patient had an negative workup for sleep apnea 12 years ago?). On the next level, all or most of a patient's providers might use the same vendor's EHR product, even if they are independent practices and hospitals. The barriers to interoperablity here are the need for a legal agreement to exchange data access and differing implementation configurations. Epic has piloted an initiative where two different providers could agree to share data on common patients with Epic providing the data exchange through a standardized version of Epic built for this purpose. However, it is more reasonable to assume that patients will continue to receive their care through multiple providers who use different EHR systems, different versions of the same system and different implementation schemas. Hence the drive to create the regional health information exchanges. However, the data that can be transmitted this way will have to be a limited subset given the different underlying systems. I believe that ASCO's work of defining cancer specific data sets (of which the Treatment Plan and Summary documents are the first step) will be critical to this aspect of heatlh care reform. Peter Yu, MD Sun, 14 Feb 2010 09:25:23 GMT f1397696-738c-4295-afcd-943feb885714:2598