The AADA has particular suggestions regarding impediments to physicians engagement in meaningful use that we will address in our remarks below.

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1 January 14, 2013 Farzad Mostashari, MD, ScM National Coordinator for Health Information Technology Office of the National Coordinator for Health Information Technology U.S. Department of Health and Human Services 355 E Street, SW Washington, DC Re: Office of the National Coordinator for Health Information Technology; Health Information Technology Policy Committee: Request for Comment Regarding the Stage 3 Definition of Meaningful Use of Electronic Health Records (EHRs); 77 FR (Nov. 26, 2012) Dear Dr. Mostashari: I am contacting you on behalf of the more than 17,000 members of the American Academy of Dermatology Association (AADA) to share our comments on the Health Information Technology Policy Committee s (HITPC) Request for Comment (RFC) Regarding the Stage 3 Definition of Meaningful Use of Electronic Health Records (EHRs). The AADA appreciates the opportunity to give an opinion on the readiness and feasibility of new objectives and measures of meaningful use of electronic health records and hopes the HITPC will take the AADA s concerns and recommendations into consideration as they develop Stage 3 meaningful use proposed rules. The AADA has particular suggestions regarding impediments to physicians engagement in meaningful use that we will address in our remarks below. General Remarks (QMWG14, QMWG15) In these preliminary Stage 3 recommendations, the HITPC s Meaningful Use Workgroup moves forward initiatives to increase use of clinical decision support by physicians and hospitals, including computerized physician order entry (CPOE), structured, machine-readable data, and medication reconciliation. These recommendations also would substantially boost requirements for data exchange amongst providers and for patient and family engagement. The AADA applauds the HITPC s support of HHS-wide efforts to align clinical quality measures across programs and its interest in alleviating administrative burden on providers. The AADA believes the lack of harmonization across reporting programs is a major impediment to physician engagement in adoption and implementation of EHRs.

2 The AADA advocates for minimizing the burden on physicians, particularly those in solo or small practice groups, by aligning quality reporting requirements across all regulatory agencies and programs--not only for the specific quality measure, but also the process or method of reporting. Harmonization must take place within the larger context of all regulatory, payor-initiated and other reporting burdens faced by physicians. Currently, practices must keep track of separate sets of reporting requirements, which disproportionately burdens small practices with limited resources. The AADA recommends that in formulating Stage 3 requirements some consideration be given to feasibility within the broader health care and fiscal environments. Physicians must balance their meaningful use effort against other demands on their time and resources. Many physicians are engaged in adopting EHR, initiating quality reporting, as well as undertaking payment and delivery reforms. The meaningful use initiative is only one of a number of critical initiatives that physicians are facing and they are facing these challenges at a time of diminishing Medicare reimbursements. Medicare reimbursement cuts further reduce resources available to practices for adopting and implementing EHRs. Particularly for small practices, the high cost of EHR adoption is not offset by existing financial incentives, and physicians face uncertainty regarding the value they will receive. Moreover, it is important to note that while meaningful use is now described as an incentive program, providers who are not meaningful users by 2014 will experience adjustments decreasing Medicare Part B professional fees in 2015 and beyond. While implementation is over 3 years away, the Stage 3 recommendations are of immediate concern to physicians because they will require physicians to begin considering implications to their business plans immediately--at a time when there are a lot of burdens competing for physicians attention and limited resources. The AADA is concerned that the cumulative impact of these additional burdens, costs and penalties is overwhelming experienced physicians, particularly those who are near retirement, and will result in significant premature departures from the practice of medicine. Moreover, the AADA believes a great deal of infrastructure must be in place to successfully engage in meaningful use. It is key for organizations, including physician practices, to have the right clinical workflows, care delivery processes, and the right support structures in place not just to meet the standards but also to ensure a sustainable transformation of these critical systems. Accordingly, the AADA supports a measured approach to advancing meaningful use, and urges the HITPC to implement policies that would prospectively develop the infrastructure foundation necessary for advancing meaningful use. Electronic Information Exchange (SGRP 101, SGRP 113, QMWG 01, QMWG 02, IEWG 101) Many of the measures in Stage 3 build upon Stage 2. The recommendations propose that care plans and clinical summary documents be exchanged in the care transition process, forcing document exchange between providers and vendors. The AADA is 2

3 concerned that exchanging information--especially beyond vendor boundaries--remains very difficult. We believe that interoperability continues to be a significant problem. Moreover, exchanging data is expensive. It is costly to take data from one system and move it to another system. We believe there is a need to address underlying problems in support, cost and safety issues, security issues, including the inability to secure data when moving between different standards and processes. The AADA urges the HITPC to advance cautiously and spend more time building this technical infrastructure and prospectively addressing standards for data transport and patient identification. In these recommendations, the HITPC intensifies its current requirement to implement clinical decision support interventions. As proposed, the clinical decision support measure requires 15 clinical decision support interventions and is a very vague measure. While the stated objective to use clinical decision support to improve performance on high priority health conditions is laudable, the AADA believes that without further clarification and an analysis of the burden this requirement would place on physicians, the recommendations could be very problematic. The AADA urges that efforts be made to enhance the accurate electronic reporting of quality measures. We are concerned that while current EHR products may be able to generate quality measure reports, the data may be inaccurate or inconsistent. Moreover, the data may not be comparable across different providers. Developing electronic specifications for reporting quality measures from an EHR is a complicated process. Those specifications must include data elements, logic and other information in a format that can be captured in the EHR and ultimately shared with other entities. The AADA believes that it is essential to thoroughly test the electronic specifications to ensure accurate quality measure reporting and meaningful quality improvement. Testing of these specifications should be completed in a test system environment using test data to assess the measure logic, as well as in a clinical environment using a live EHR system with actual patient clinical information. The AADA further recommends testing EHR specifications across varying practice sites using different Health IT software. Moreover, we believe it is important to develop standards that allow for the unambiguous exchange of information across settings. The AADA believes the recommendation calling for providers (SGRP 101) to incorporate clinical lab-test results into Certified EHR Technology as structured data will strain small practices. This objective requires incorporating lab data into an EHR to easily capture the data through the exchange of health information. Each lab, however, has a different interface and each health plan has their preferred lab. Moreover, most small practices are low volume users. As a low volume user, the cost to exchange data is not subsidized by the lab, and practices are forced to pay a fee per click and interface. The AADA is concerned that providers will be penalized for their inability to exchange information notwithstanding that the impediment is the labs, which have no incentive to communicate with providers. We believe a major challenge with implementing computerized physician order entry (CPOE) is usability, and the necessity of conforming CPOE to the workflows of varied 3

4 practices. The AADA urges the HITPC to work towards advancing usability to remove this impediment to meaningful use engagement. Moreover, the AADA is concerned that many of the measures are structured to fit into national health priorities, but not all specialists fit this mold. Accordingly, the AADA urges the HITPC to look at specialties and make meaningful use requirements more inclusive by tailoring measures for specialties to allow all to participate fully. The AADA urges that quality measurement methodologies be developed with flexibility to accommodate all specialists and their varying practice patterns and patient populations. The AADA urges that consideration be given to offering providers greater incentives to adopt and implement Information exchange among providers. Moreover, the AADA urges that policy be crafted so all stakeholders physicians, other providers, vendors, and patients--share accountability. Patient Engagement (SGRP 204A-SGRP 209, QMWG07, QMWG08) The AADA believes that Stage 3 meaningful use requirements and measures should be designed and used to advance meaningful physician-patient interaction. We acknowledge the role that well-developed EHRs can play in improving quality of care delivery, enhancing patient safety, and supporting practice efficiencies. We believe it will not be easy from a technical perspective to achieve the recommended Stage 3 patient-engagement goals. The recommendations provide for patients and families to have the ability to include information in the EHR. In addition, under the recommendations, physicians would be required to provide patients with the ability to request an amendment to their record online (e.g., offer corrections, additions, or updates to the record) through a patient portal. The AADA urges caution in advancing the recommended requirements because achieving the level of EHR functionality that is required to perform these functions will be very challenging, Vendors will have to make it feasible to merge documents into the EHR and accept downloads from mobile and medical equipment applications. Much of this will require new technical specifications. In addition, there is a lack of industry standard data sets for patient-generated data. Moreover, while the AADA recognizes the value that patient-generated health information may provide, the AADA believes that prior to implementation, we need greater clarity regarding standards. Currently, most health care providers have little experience with collecting and using patient-generated health information in this way. A recent AADA HIT Survey found that less than 50% of dermatologists even have the capability to communicate with patients electronically through their EHR. The AADA advocates that more work must be done to determine what information can give providers a more detailed and accurate picture of a patient s health, facilitating better clinical treatment plans and more informed decision-making. 4

5 There are challenges that must be addressed as health care providers begin to electronically incorporate patient-generated health information into clinical care. We believe there remain unresolved questions about whether electronically accepting patient-generated health information from a PHR or other patient-controlled tool could subject providers to heightened risk for claims of medical malpractice, whether physicians would be liable for the failures of their staff to respond to or accurately interpret electronic health information from patients, and whether providers can trust the accuracy of patient-generated data. Accordingly, the AADA expresses concern over the proposed new measures, and urges the HITPC to resolve these issues before implementation. The AADA urges the HITPC to eliminate requirements that grade physicians on adherence from a party other than a physician (e.g., measures based on a patient s use of technology). We cannot improve the quality of health care delivery with measures that require a physician to be responsible for the functionality of vendor programming and the subsequent interoperability factors that are not in the physician s control. If the methodology applied to physicians does not appear reasonable, it will serve as a barrier for physician engagement in Stage 3 meaningful use. The AADA also is concerned with the speed in which patient engagement is being expanded. The AADA believes there is significant infrastructure building that needs to take place in advance of ramping up patient engagement requirements and recommends against haphazardly moving forward without that infrastructure in place. The infrastructure/technical architecture necessary to support these recommendations needs further development. In addition, the AADA specifically recommends against implementing SGRP 206, which would require physicians to provide 80% of patient-specific education materials in at least one of the top 5 non-english languages spoken nationally, based on the local population. Many dermatology practices are solo or small practices and this could be a very expensive provision for those providers to implement. The AADA urges that consideration be given to the costs and other burdens that this proposal would impose on physicians. The AADA believes the Policy Committee s patient generated health information recommendations may be difficult if not impossible for many dermatology practices to meet, and accordingly, we urge the HITPC to rethink these recommendations when developing the proposed rules. Privacy and Security (PSTT04, MU04) The HITPC s RFC focuses on obtaining information on multi-factor provider authentication for provider users remotely accessing protected health information, as 5

6 well as security risk issues that should be subject to meaningful use attestation in Stage 3 and standards for accounting of disclosures. The AADA is concerned that many practices and other provider organizations are being challenged to meet standards on privacy and security of patient information as prescribed by both meaningful use and the Health Insurance Portability and Accountability Act (HIPAA). The AADA believes that transmission and exchange of patient data or information across the enterprise must be very solid and secure. Specifically addressing PSTT04, the AADA recommends against requiring that physicians attest to implementing HIPAA Security Rule provisions regarding workforce/staff outreach & training and sending periodic security reminders. Raising awareness of staff of the HIPAA Security Rule provisions superficially speaks to HIPAA compliance, but it does not address the substantive technological issues of keeping information secure. For example, use of mobile devices to generate and communicate health information subjects this potentially sensitive information to increased security risks, and the security risks presented by these transmissions must be adequately addressed. Successfully engaging in meaningful use will require expanded focus on secure transmission of data within and outside of the enterprise. The AADA urges the HITPC to give greater attention to existing technological deficiencies that foster security breaches. Additionally, the AADA would recommend that CMS or the Office of the National Coordinator provide additional educational resources on HIPAA to small physician practices. Conclusion The AADA appreciates the opportunity to provide comments on these important issues to assist the HITPC in formulating future policy that targets a collaborative model of care with shared responsibility and accountability. Please contact Richard Martin, Assistant Director, Regulatory Policy, at (202) or rmartin@aad.org if you require clarification on any of the points or you would like more information. Sincerely, Daniel M. Siegel, MD, MS, FAAD President, American Academy of Dermatology Association CC: Zoe D. Draelos, MD, FAAD, Vice President Dirk M. Elston, MD, FAAD, President-Elect Suzanne M. Olbricht, MD, FAAD, Secretary-Treasurer 6

7 Marta Jane VanBeek, MD, MPH, FAAD, Chair, Council on Government Affairs, Health Policy, and Practice Eileen Murray, CAE, Acting Executive Director 7