January 14, 2013 Submitted electronically Office of the National Coordinator for Health Information Technology HIT Policy Committee Department of Health and Human Services Patriots Plaza II, 355 E Street, SW Washington, D.C. 20201 RE: Request for Comment – Stage 3 Definition of Meaningful Use Dear HIT Policy Committee: The undersigned consumer organizations are members of the Consumer Partnership for e-Health (CPeH). The CPeH is a coalition of more than 50 consumer, patient, and labor organizations working at the national, state, and local levels to advance private and secure health information technology (health IT) in ways that measurably improve the lives of individuals and their families. The combined membership of CPeH represents more than 127 million Americans. CPeH appreciates the opportunity to provide input on Stage 3 advancements in the definition of meaningful use of health IT. In Stages 1 and 2, the Meaningful Use Electronic Health Record (EHR) incentive program created foundational capabilities for delivering care differently and supporting payment models that incentivize the kind of health care individuals need and deserve. In Stage 3, we need to begin movement beyond the medical model to a more comprehensive, person- and family-centered model for supporting health and wellness.1 Robust advancement of Stage 3 Meaningful Use criteria that focus on improvement of outcomes is critical to ensure that the outlay of public funds through this program results in a healthier population, better care, and more affordable healthcare costs. Below are the priorities we believe to be most critical to the achievement of this Triple Aim2. 1 For purposes of brevity, we refer throughout our comments to “patient’ and “care,” given that the Meaningful Use incentive program is rooted in the medical model. It is important to note, however, that meeting the goals of the Triple Aim will require a shift away from an exclusive medical model approach toward a more person- and familycentered approach that emphasizes wellness, prevention, and community-based supports, in addition to traditional medical interventions. "Patients" and "care" imply a medical model with a focus on episodes of illness and exclusive dependency on professionals. Any effort to improve patient and family engagement must include the use of terminology that also resonates with the numerous consumer perspectives not adequately reflected by medical model terminology. For example, the health care community may refer to “care planning,” while the independent living movement would use the terminology “integrated person-centered planning.” People with disabilities frequently refer to themselves as "consumers" or merely "persons." Choice of terminology is particularly important for purposes of care planning and care coordination, when the worlds of independent living and health care provider often intersect. 2 Berwick, D. M., Nolan, T. W., and Whittington, J., The Triple Aim: Care, Health, And Cost. Health Affairs, 27, no.3 (2008):759-769 Page 1 Priority #1: Supporting Partnerships Among Patients, Their Family Caregivers, and Their Care Team Health IT is a tool that can be used to engage consumers as equal members of their health care team by equipping them to work in partnership with professional care team members, make better choices, and live healthier, more fulfilling lives. Consumers can be true partners only if they have access to the information they need to be engaged in care. Stage 3 must advance patient and family caregivers’ ability to both access and contribute to their own health information – a critical component of electronic health information exchange. Advance Directives - SGRP #112 We strongly support transitioning to core the criterion to record advance directive status for Eligible Hospitals (EHs), and adding the criterion as a menu objective for Eligible Professionals (EPs). Advance directives are a critical and well-accepted means of empowering patients to identify the care they want, as well as the care they do not want in specific circumstances. CMS data show that recording advance directive status has been among the most popular menu items of Stage 1for EHs, underscoring the value of advancing this objective in Stage 3. We urge HITPC to advance this objective more aggressively in Stage 3 by requiring that the content of an advance directive be accessible through the EHR, in addition to a notation about its existence. The specifics of an advance directive constitute essential patient preference information that is necessary in order for providers to act according to their patients’ choices. Patients and providers would benefit significantly from this information being available at the point of care, and there are technological solutions available today that make this possible, such as the MyDirectives website.3 Leveraging existing and future technical solutions for making advance directive content available at the point of care is a meaningful way to incentivize greater information exchange in Stage 3. Information in advance directives should, in the future, inform Clinical Decision Support (CDS) to ensure that individuals receive care according to preferences they have specified. A significant first step that can and should be taken in Stage 3 is to make the content of an advance directive available electronically. Availability of electronic advance directive content provides essential information about an individual’s goals for their care, and therefore is also a foundational step toward development of a comprehensive, shared care plan. To maximize the potential of this criterion, we also suggest lowering the 65 year age limit to all adult patients (18 years and older). Certification criteria should require that the capture of this information is possible for any patient (regardless of age). 3 http://mydirectives.com/ Page 2 View/Download/Transmit - SGRP #204A Giving patients the ability to view, download, and transmit (VDT) their own health information was a monumental advancement for consumers in Stage 2 of Meaningful Use. We applaud the advancement of this criterion toward real-time health data access and inclusive electronic health information exchange by accelerating the time frame for making information available to 24 hours. We strongly support further advancing the threshold in Stage 3 for both the percentage of patients provided electronic access to their health information, and the percentage of patients who use V/D/T capability. To be truly transparent, we urge HITPC to require that V/D/T criteria apply to entire medical records, such as visit notes. HITPC should build upon experience from the Open Notes initiative,4 which provides patients electronic access to read their doctors’ visit notes. In a quasi-experimental study, the vast majority of participants having access to their notes reported an increased sense of control, greater understanding of their medical issues, improved recall of their plans for care, and better preparation for future visits,5 all of which are critical components of patient engagement and better health outcomes. Participating providers experienced minimal impact on their workload. Furthermore, when providers were offered the option to decline further participation at the end of the intervention, none asked to stop. Additionally, HITPC should be working with stakeholders to ensure that consumers can view, download, or transmit their health information using diverse and accessible technology platforms, including mobile technologies, and in the patient’s preferred language. Consumers need a comprehensive and accurate view of their health and healthcare, and should be able to direct their health information based on personal preferences. Depending on Stage 2 experience, we recommend exploring opportunities to leverage the automated Blue Button function to direct a provider to transmit an individual’s health information to another location of their choosing (e.g., from specialist to primary care portal or non-provider affiliated personal health record). This approach would meet the intent of the V/D/T criterion while also limiting provider burden and avoiding the unintended consequence of patients having to manage information using multiple portals that do not connect to each other. We are concerned that the availability to patients of some critical lab data may still be delayed. We advise HITPC to shorten the time by which providers must make available lab results that are unavailable at the time of the encounter to two business days. 4 http://www.myopennotes.org/ Delbanco, T., Walker, J., Bell, S. K., Darer, J. D., Elmore, J. G., Farag, N., Feldman, H. J., Mejilla, R., Ngo, L., Ralston, J. D., Ross, S. E., Trivedi, N., Vodicka, E., Leveille, S. G., Inviting Patients to Read Their Doctors' Notes: A Quasi-experimental Study and a Look Ahead. Annals of Internal Medicine. 2012 Oct;157(7):461-470. 5 Page 3 Patient-Generated Health Information – SGRP #204B We enthusiastically support the new Stage 3 criterion to offer patients and family caregivers the ability to contribute information to their medical record that is specific and material to their care. This is a pivotal opportunity to improve performance on high priority health conditions, address unnecessary readmissions, and enhance patient and family engagement in care. The information patients and their family caregivers provide about their abilities and support needs for self-management complements clinical information generated by care teams to provide a comprehensive, person-centered view of an individual’s health. As the healthcare system shifts towards whole-person care, greater support for prevention, wellness, and independent living is essential. Effective care planning and coordination require a comprehensive approach that is not exclusively focused on interactions with the healthcare system. Use of both clinical and patient generated data is a more effective approach for engaging patients and their families, ensuring that care results in better outcomes, and decreasing costs associated with unnecessary readmissions and difficulties with adherence. While we appreciate establishing a modest threshold for new criteria, we urge HITPC to increase the threshold for this criterion to at least 25 percent. This information – which is often only available from the patient or a caregiver – is particularly valuable for care planning and coordination, and is essential for meeting the goals of the Patient Centered Outcomes Research Institute (PCORI), created by the ACA. A more meaningful threshold would help to establish patients as valuable sources of health information, which is critical to the culture change necessary for patient- and family-centered, high-quality care and to the development of evidence with regard to person-centered outcomes. The HITPC should specify a wide range of categories of high-value, patient-generated information that have the most potential to significantly improve health, safety, and quality. The kinds of information that consumers feel is of highest value for their providers to know from their perspective include, but are not limited to: o Goals for care o Medication allergies and non-tolerated medications (i.e., those which in the past have caused negative side effects for the individual), including over-the-counter drugs and herbal supplements o Caregiver (using DECAF6) and additional professional care team member name(s), contact information, and role(s) o Family history o Functional limitations 6 DECAF is a standardized approach to defining the types and intensity of the roles family caregivers play to facilitate improved communication. Each letter refers to a different type of contribution made by a family caregiver: D= Direct Care Provision, E= Emotional Support, C= Care Coordination, A= Advocacy, and F= Financial http://www.caretransitions.org/documents/Executing%20high%20quality%20-%20JHM.pdf Page 4 o Supports and services necessary for independent living o Patient values and preferences for care (e.g., advance directives, no blood products, etc.) o Patient experience o Behavioral and mental health history o Identification of problems or concerns from the patient’s perspective o Psycho-social information, such as family support, caregiver limitations, financial constraints, living situation, independent living skills, and activation level o Data recorded by patient for monitoring of progress toward patient goals o Risk factors indicated by structured surveys (such as health risk assessments) Patients and family caregivers manage their health in the context of a multitude of priorities and life circumstances. These priorities and circumstances have a direct bearing on their effectiveness in home and self-care, and therefore constitute information that is material to their care – whether or not they have a high-priority health condition. An equally important goal for collecting patient generated health data is to engage patients and their family caregivers as sources of information. For these reasons, this criterion should apply to all MU eligible providers and all patients, and not be limited only to patients who have high-priority health conditions. As efforts to measure and improve health outcomes continue, it will be critical to link patientgenerated data to CDS technologies to generate alerts based on the non-clinical needs of patients, including their preferences for care. To make progress toward this goal, we suggest increasing the threshold to 25 percent and allowing providers to select one or more of the above areas most pertinent to their patient population from which they will collect data directly from their patients and/or their caregivers. Finally, we note the importance of patient identity-proofing and information authentication in the shift toward patient-generated information. The HITPC should prioritize dissemination of the newly adopted best practices for identity proofing and authentication for private and secure use of patient portals, developed by the Privacy and Security Tiger Team. Record Amendments – SGRP #204D As a coalition of consumers, we strongly support the new Stage 3 criterion to provide patients with an ability to record an amendment to their health record online, as they are often the first to identify errors in their own records. Increased access by individuals to their own health information, as a result of Stage 2 criteria, will conceivably increase the number of errors identified by patients, thereby underscoring the need for this capability. This criterion helps to ensure the accuracy and reliability of data stored in an EHR, while simultaneously empowering patients and their caregivers to be active partners in their health and healthcare. This new criterion is also a stepping stone toward a more widespread and inclusive view of patients as Page 5 important sources of information. Clinical Summaries (Post Office Visit) – SGRP #205 Clinical summaries support the success of patients and families in home and self-care, and are key components of any strategy to reduce avoidable hospitalizations and associated costs. HITPC should build on lessons learned from Stage 1 and require in these care summaries information that is meaningful and actionable to patients and their caregivers. Feedback from patients, their families, and providers indicated that the format and content of previous after-visit summaries were failing to provide meaningful and actionable information. The summary is intended to summarize what transpired during the office visit, explain treatment recommendations, and specify necessary follow-up care and next steps. To achieve this purpose, we encourage HITPC to work with clinicians and patients to determine the most helpful data elements to include, such as side effects, potential complications, and when to call a doctor. The way the clinical summary information is presented to the patient is equally important as the kinds of information that are included. HITPC should consider ways to enhance the usability of these documents. For instance, HITPC could advise ONC and CMS to develop guidance and resources promoting plain language and a standardized format – similar to nutrition labels. Graphic explanations are also extremely helpful to patient understanding, and should similarly be promoted. Secure Patient Messaging – SGRP #207 Secure messaging is a critical step toward advancing access, care coordination, and information exchange between patients, caregivers, and providers by enabling more efficient responses to questions and communication of basic information. Secure messaging is another important source of patient-generated data, which is critical to a comprehensive view of individual health. We supports the increased threshold in the Stage 3 RFC. Allowing secure messages sent and received by a family or other caregiver approved by the patient to count towards the increased threshold is advisable, and would reinforce their essential role as members of the care team. We also urge the HITPC to add a criterion measuring timeliness of response from providers to their patients who use secure messaging. We do not propose requiring a specific timeliness standard, only the measurement and reporting of timeliness rates, as is current practice for industry leaders such as Kaiser Permanente. Communication Preferences – SGRP #208 As consumers, we fully support the inclusion of a separate criterion to record patient communication preferences. This is vital to ensuring that patients receive information in a Page 6 medium that is most accessible and meaningful to them, which promotes enhanced patient and caregiver engagement and follow-up. EHRs should have the capability to differentiate preferences for varying kinds of information. For example, individuals may want to receive lab results by email, but prefer phone call or text message reminders regarding upcoming appointments for follow-up care. We urge HITPC to include the capability to record caregiver communication preferences in certification criteria and to require collection of communication preferences for at least the primary caregiver, where applicable. This is particularly important for EHs, given the importance of safer, more effective care transitions and the role caregivers play in that process. Identifying Available Clinical Trials – SGRP #209 We support requiring the capability for EHRs to identify relevant clinical trial opportunities for individual patients as a way to introduce efficiencies for both providers and patients in terms of identifying potential trials for patient participation. Facilitating communication between health practitioners, the research community, and patients and their caregivers is critical to advancing cures and treatments, and ensuring patient access to them. Priority #2: Improving Coordination of Care Consumers want better communication among and collaboration between providers, patients, and their caregivers. Ensuring that the right information is available to the right person at the right time will facilitate better outcomes that are more affordable for everyone. Medication Reconciliation – SGRP #302 We strongly support the increase in the threshold for medication reconciliation to 50 percent in Stage 3. We also enthusiastically support supplementing medication reconciliation for transitions of care with reconciliation of medication allergies and problems, and encourage advancement of the threshold in future stages. This criterion is essential for improving care coordination and safety. Patients and their caregivers are valuable sources of information and should be included in the reconciliation process for specific information, especially information that is likely to change between encounters with the health care system. There are numerous opportunities to leverage the intent of the patient-generated health information criterion through advancement of the reconciliation of information criterion. Opportunities to engage patients and caregivers in information reconciliation include: o Medications actually taken (including over-the-counter drugs and herbal supplements) o Caregiver name, contact information, and role o Problems/complaints Page 7 o Advance directive status and content o Additional care team members (primary care, specialists, ER, retail clinics, etc.) Summary of Care Record – SGRP #303 This criterion is the primary vehicle for promoting robust, electronic exchange of health information, and therefore the proposed threshold of 30 percent is far too low. CMS data shows that, as of November 2012, 84 percent of all EHs were registered and 68 percent for paid for successful meaningful use, while 63 percent of all EPs were registered and fully one out of three were paid. Further, CMS expected December 2012 to be the biggest pay-out month to date, by threefold.7 Given the rapidly increasing pace of EHR adoption and the time remaining between now and the advent of Stage 3, it is more than reasonable to require more widespread information exchange in Stage 3. By the time Stage 3 is implemented, information exchange capabilities will be more widespread, making a higher threshold more feasible than it may seem today. Furthermore, meaningful and effective coordination of care requires electronic sharing of information across all providers, in addition to those eligible for Meaningful Use incentives. In stage 3, providers earning taxpayerfunded incentives should be exchanging data regularly with non-MU eligible providers, such as skilled nursing facilities (SNFs) and home health agencies (HHAs). We strongly urge HITPC to increase the threshold of the percentage of summary of care records that are provided electronically well beyond the 30 percent proposed. We suggest a criterion that requires 80 percent of patients to have summary of care records shared, with no less than 65 percent transmitted electronically. By significantly increasing both thresholds, MU eligible providers will be encouraged to begin exchanging data with SNFs and HHAs in their communities that have the capability to receive electronic information. The Direct standard of health information exchange8 is one method of achieving this goal, even in cases where a receiving provider may not have a full EHR. Electronic transmission of a summary of care record has been a practical starting place for advancing meaningful information exchange that provides a static view of an individual’s condition and needs at the time of a transition or referral. We strongly support advancing this criterion in Stage 3 through the addition of a list of care team members, goals, instructions, and a narrative summary of information critical for a safe, effective transfer of care. When recording caregiver information, the DECAF classification system should be used. 7 Rob Anthony, HIT Policy Committee meeting, January 8, 2013 The Direct Project specifies a simple, secure, scalable, standards-based way for participants to send authenticated, encrypted health information directly to known, trusted recipients over the Internet. http://wiki.directproject.org/file/view/DirectProjectOverview.pdf 8 Page 8 We suggest that HITPC require the inclusion of both patient-defined and clinical goals as part of the summary of care record. Requiring both kinds of goals will prompt discussion that otherwise may not occur, and will be an important facilitator of shared decision-making. While the summary of care record provides a discrete snapshot in time, the inclusion of health goals that reflect both clinical objectives and individual aspirations will support the beginning of the necessary shift from delivery of care in silos to better coordinated care, and will also recognize patients and caregivers as central actors in the care planning and delivery process. In addition to the categories of information required in the RFC, it is critical to begin providing information about functional status and independent living services and supports at the point of transition or referral. This information makes a significant difference in how prepared a receiving provider is for meeting the needs of the individual being referred or transferred, and therefore is essential to the quality and safety of care. We support the certification criteria proposed in the RFC, which create the capacity for additional steps toward a longitudinal, shared care plan by requiring certified EHRs to enable a concise narrative section, automatically populate a referral form for specific purposes, and include data elements related to consultation requests and transfers and care. Care Plans – SGRP #304 We feel very strongly that HITPC should not wait for future stages of Meaningful Use to begin advancing the capacity of EHRs and health information exchange to support a comprehensive, interactive shared care plan platform. Care plans are necessary to provide a roadmap for achieving the best possible outcomes, as defined by both clinical and individual patient goals. Care plans also present a valuable opportunity to collect and synthesize patient-generated data with clinical data across care settings. Ultimately, we are working toward care plans that are interactive, real-time, and operational across settings, as opposed to static documents. While achieving this vision is beyond the scope of Stage 3, there are important steps that can and should be taken in Stage 3 to build the necessary foundation for interactive, flexible, accessible care plans. In Stage 3, HITPC should advance the concept of the longitudinal, shared care plan by requiring documentation of a cross-setting care team member list, comprehensive patient goals (not setting specific), and psycho-social assessment information, such as behavioral health needs, living situation, and community-based resources. When more than one professional care team member is listed, a notation should be made regarding who serves as the primary contact so that the patient and family member are never without a clear point of contact. These pieces of information build upon the summary of care record, engage patients and their caregivers in the planning of care (rather than exclusively at the point of decisionmaking about a medical intervention), and provide the necessary foundation for a more personfocused, comprehensive, integrated plan of care. They also incentivize electronic exchange of information, since electronic exchange would significantly reduce provider burden in meeting Page 9 this criterion. We suggest that the threshold for this Stage 3 criterion be 20 percent of all patients. Closing the Referral Loop – SGRP #305 We fully support the new criterion to close the referral loop and encourage threshold advancement in future stages. We encourage the HITPC to consider making this information available through the patient portal in order to include the patient and his or her family caregiver(s) in the closing of the information loop with regard to referrals. Notice of a Significant Healthcare Event – SGRP #308 We also strongly support the addition of a core criterion regarding significant event notification for EHs, as it compliments SGRP #305 by “looping in” clinicians who are part of an individual’s care team, but may not be aware of significant health events and interventions by other members of the care team. Priority #3: Increasing Health Equity Improving health equity requires collection and use of data to identify differences and target solutions that reduce disparities. In addition, the technology itself should be used to address the root causes of disparities. Health IT should be used as a tool for both identifying and reducing health disparities, so that outcomes for underserved populations are not just improved, but also result in greater health equity. Record Demographics – SGRP #104 We caution the HITPC that retiring this objective could have adverse effects on health disparities, especially since there is no requirement in Stages 1 or 2 to actually use this data for purposes of decreasing disparities. If the HITPC chooses to retire this criterion, it should require the use of demographic data, and specifically disparity variables, in both functional criteria and quality measurement. We respectfully remind the HITPC that the HHS Office of Minority Health “National Stakeholder Strategy for Achieving Health Equity” identified the availability of health data on all racial, ethnic, and underserved populations as a key strategy for achieving health equity.9 In our view, this constitutes a mandate to ONC to ensure that such data is accurately collected and made available in meaningful and useful ways through the use of health IT. Regardless of whether this objective is retired, we strongly urge HITPC to require the stratification and reporting of patient lists and clinical quality measures, respectively, by demographic data. This significant opportunity, which has not yet been leveraged, will reveal specific disparities in care within a provider’s patient population, and support the creation of strategies to reduce and eliminate them. 9 National Partnership for Action to End Health Disparities. National Stakeholder Strategy for Achieving Health Equity. Rockville, MD: U.S. Department of Health & Human Services, Office of Minority Health, [April 2011]. Page 10 We urge HITPC to make the collection of sexual orientation/gender identity data mandatory, rather than optional. Gathering such demographic information in EHRs is supported by other Health and Human Services initiatives, such as Healthy People 202010 and Section 4302 of the Affordable Care Act, as well as recent Institute of Medicine (IOM) reports11,12. A 2012 IOM workshop explored the benefits of collecting sexual orientation and gender identity data in EHR systems. A provider’s knowledge of a patient’s sexual orientation and gender identity is essential to providing appropriate screening and care.13 Gathering sexual orientation and gender identity data will also increase our understanding of lesbian, gay, bisexual, and transgender (LGBT) health disparities and how to prevent and detect health conditions that disproportionately affect LGBT people. Without this most basic data, there can be no progress in ensuring that the LGBT community receives the quality of care that all people deserve. Additionally, we strongly encourages HITPC to require the collection of disability status data. This is an important point of alignment with the Affordable Care Act, which requires data collection on race, ethnicity, sex, primary language and disability status. Determining disability status is complex, and the definitions of disability vary even among federal programs. These differences have significant implications for social services and resource eligibility, as well as individuals’ ability to be independent at home and effective in their self-care. We encourage the HITPC to consult with the Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities (NCBDDD), and National Center on Health Statistics (NCHS), Disability and Health Data Systems program for guidance on how to most effectively incorporate disability status into Stage 3. We also encourage the committee to consider the value of distinguishing medical disability status from equally important patient-reported information about functional impairment. Accommodation or assistance needs for functional impairments (e.g., American Sign Language interpretation, Braille or large font, mechanical lifts or transfer assistance, among others) are critical facilitators for quality care and patient engagement. To obtain data from patients regarding functional impairments, we suggest that HITPC consider the use of American Community Survey (ACS) questions,14 supplemented by additional questions to capture any relevant needs not otherwise addressed. 10 United States Department of Health and Human Services, Healthy People 2020. (2011, June 29). Institute of Medicine. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. Washington, DC: The National Academies Press, 2011. 12 Institute of Medicine. Collecting Sexual Orientation and Gender Identity Data in Electronic Health Records Workshop Summary. (2012,December 20). 13 U.S. Department of Health and Human Services. Affordable Care Act to improve data collection, reduce health disparities. News release. June 29, 2011. www.hhs.gov/news/press/2011pres/06/20110629a.html 14 http://www.census.gov/acs/www/Downloads/QbyQfact/disability.pdf 11 Page 11 Condition Reports and Patient Dashboards – SGRP #115 We fully support this measure and its advancement in future stages, and believe the measure can be leveraged to strengthen disparities reduction efforts. Making these dashboards available to patients and their caregivers will be critical for decision-making and care coordination, especially during transitions of care. Non-English Patient-Specific Education Materials – SGRP #206 We fully support utilizing data collected about a patients' preferred languages to provide access to meaningful, useful education materials. We encourage greater clarity regarding the measure denominator. Instead of “Provide 80% of patient-specific education materials in a at least one of those languages,” the denominator should focus on percent of patients. The measure should read: “80% of a provider’s patients preferring one of the top five non-English languages spoken in the US receive educational materials in their own language.” HITPC could also consider modifying the measure to include the top five non-English languages spoken in the state where the EP/EH is located, in order to promote greater relevance to the community in which an individual lives. We urge HITPC to encourage providers to strive to offer materials in the language spoken by their patients, no matter what that language is. Priority #4: Enabling New Payment & Delivery Models Health IT is an essential foundation for delivery system and payment reforms. New models of care all require the ability not just to share data, but to integrate it across various sources (including non-EHR) and across various types of data (i.e., clinical, claims, and patientgenerated data).15 Stage 3 Meaningful Use must advance progress in these areas to support care delivery improvement and accountability for improved outcomes. The Fundamental Mission of the EHR incentive Program Clinical Quality Measure (CQM) Set – QMWG #01 We agree with the mission statement in the RFC, as long as “promoting the capabilities of EHRs” includes promoting new capabilities not yet utilized in current EHR products. The kinds of measures necessary to support new payment and delivery models are possible in an electronic environment, but systems and infrastructure must be designed accordingly. We believe that it is absolutely essential for quality measures used in the incentive program to stretch the capacity of EHRs to support more meaningful quality measurement. Only then will we have quality metrics that both reduce the burden of data collection and provide the kinds of data necessary to support new payment and delivery models and achieve the three-part aim. 15 Commonwealth Fund report on Measuring progress toward accountable care Page 12 High Priority Measures – QMWG #02 New payment and delivery models require new and different kinds of quality metrics that leverage current and potential capabilities of EHRs. In many cases, such measures are not currently available. There is work yet to be done to ensure that health IT increases the feasibility of new, high-value measures. To that end, we urge the HITPC to ensure that technology developers create and enable the functions and capabilities necessary for capturing information required to populate measures of patient engagement, care coordination, functional status, longitudinal (delta) measures, wellness and health promotion, and population-based measures that can be used to improve health, reduce disparities, and decrease costs. The capabilities required for these kinds of measures, which HITPC should prioritize in Stage 3 functional criteria, include health information exchange, calculation of measures using multiple data sources, and integration of patient-generated data. Consumer-Reported Data – QMWG #07 New payment and delivery models all contain significant emphasis on engaging patients and many include input from patients themselves in determining value of and accountability for health care services. Patient experience surveys are among the most common vehicles for obtaining this kind of input and they provide critical insights into quality care. Both Patient Centered Medical Home (PCMH) Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey questions and H-CAHPS survey questions should become part of Meaningful Use both in quality measures and functional capabilities. In the future, consumer-reported data should also be incorporated into CQMs by including certain consumer-reported data elements in the denominator of relevant measures. For example, a measure that is intended to assess whether an individual received the appropriate treatment for depression would incorporate information from clinical guidelines, as well as patient preference data relative to how well that treatment option accommodates his or her personal preferences. In this case, personal preferences might include not wanting to take a drug that contributes to weight gain; a quality measure that incorporates consumer-reported data could reflect both consistency of care with accepted guidelines (was this the most effective treatment according to clinical evidence) and patient preferences (was this the best treatment for this patient, given his desire not to gain weight). Patient-Contributed/Directed Data and Shared Decision-Making – QMWG #08 The response to QMWG 07 above is one example of how patient-contributed data could be used for shared decision-making. Building high-value elements of patient-contributed data into clinical decision support would provide a structured way to use patient contributed data in shared decision-making. Page 13 High Priority Domains – QMWG #16 Prioritized attention should be given to filling measurement gaps in the areas already identified by ONC in 2010. The measure domains of most importance to consumers include patientreported outcomes, care coordination, equity, patient-engagement, efficiency and prevention. EHRs also need to be able to draw data for quality measurement from multiple data sources, including registries and other population-based sources. Patient-contributed data must also be used as a source, and some outcomes measures, especially those associated with prevention, will require data from non-healthcare sources (e.g., missed school days). Clinical Quality Measurement Pipeline: Meaningful Use & Innovation - QMWG #18 and QMWG #19 Creating the capacity for better quality metrics through functional criteria in the Meaningful Use incentive program is only part of what is necessary to support new models of care and payment. The development of measures that leverage these capabilities must also be a priority. Therefore, we strongly supports the inclusion of a voluntary innovation track for quality measurement in the EHR Incentive Program. We also feel strongly that if HITPC suggests such an alternative, it should also set specific parameters and criteria that will help ensure value from this novel approach. HITPC would also need to work closely with the HIT Standards Committee to ensure that certification criteria support the use of EHRs in conjunction with new measure authoring tools being developed by the National Quality Forum (NQF). The EHR Incentive program is a unique opportunity to address measurement gaps, since it is not a quality measure performance or accountability program. CMS could promote rapid-cycle measure development by encouraging eligible providers and others to create, test, and report on measures that meet robust criteria in each of the six domains identified by the HITPC and its Quality Measures (QM) work group. This sort of real-world testing is a critical part of the NQF endorsement process. In addition, developing and testing new measures as a byproduct of practice encourages the use of real-time, clinical data. Finally, an essential benefit of developing measures as part of the MU process is that it would be done in the electronic environment in which these new measures will be implemented, rather than re-tooling a measure designed for the paper world. Creating such an option would result in shared learning and testing of new measures that advance ability of EHRs to help measure outcomes. For purposes of ensuring value, we would suggest that eligible measures be outcome focused, or process measures that are submitted as part of a “suite” of measures having close proximity to a desired outcome measure. We also feel strongly that eligible measures must addresses one or more of the key gap areas identified by the QM workgroup in 2010, including patient-reported outcomes, quality of shared decision-making, appropriate invasive testing, patient activation and self-management, adverse drug events, health care acquired conditions, adverse events and suboptimal outcomes from chronic conditions. Highest priority should be placed on measures that Page 14 address the six domains of the national quality strategy, particularly care coordination, patient engagement, and efficient resource use. Finally, HITPC should encourage those selecting this option to develop measures that use data across multiple data sources (i.e., across settings of care, between patient and provider, with registries, etc.) and that evaluate patient health/functional status over time, using data contributed by the patient to the EHR. HIT Policy Committee Questions MU01 – We are very much in favor of ensuring that the EHR Incentive Program truly incentivizes innovative use of technology to improve outcomes, without placing unreasonable demands on providers who are making good faith efforts to transform the care they provide. Our concern about any effort to reward providers with incentives for meeting most, but not all, criteria is the lack of specificity about how such flexibility would be implemented. Criteria that are most transformative, by their very nature, are more difficult to achieve. Furthermore, these are the criteria which tend to be most meaningful to consumers. As we have seen in the attestation data presented by CMS, deferral rates are already high for the menu criteria that are most transformative. We respectfully remind HITPC that there is already flexibility built into the criteria in the form of menu criteria. Partial credit may be an option to consider for offering additional flexibility during subsequent penalty phases, but must be carefully designed such that patient and family engagement and care coordination criteria are not optional. MU03 – While health IT, and EHRs in particular, have great promise to enhance patient safety, there are risks associated with improper implementation and utilization of health IT systems, and human interaction with technology. We applaud the recent release of the Health IT Patient Safety Action and Surveillance Plan, and ONC’s efforts to ensure the safety of health IT. Health IT safety risk assessments, or at least a formalized mechanism for reporting safety issues (both with regard to the design of health IT products and the human factors involved in the use of those products), is highly advisable. MU05 – Building capacity for sending and receiving key categories of patient-generated data is one concrete way to foster innovation in sharing information. We encourage HITPC to build capacity for exchanging information from structured surveys focused on critical gaps in information that is highly relevant to the care and management of an individual. This would effectively leverage the “transmit” function and move providers toward the exchange of essential contextual information. Thank you once again for the opportunity to provide input into this transformative program. We remain eager to work with the HITPC to ensure value for all stakeholders, and we are Page 15 increasingly enthusiastic about the value consumers, specifically, will see as these criteria are implemented by providers serving their communities. Sincerely, AARP American Association on Health and Disability American Hospice Foundation Asian & Pacific Islander American Health Forum Caregivers Action Network Caring From a Distance Center for American Progress Center for Democracy & Technology Center for Medical Consumers Childbirth Connection Colorado Consumer Health Initiative Colorado Cross-Disability Coalition Consumers Union of United States Healthwise National Consumers League National Health IT Collaborative for the Underserved National Health Law Program National Partnership for Women & Families National PACE Association Summit Health Institute for Research and Education, Inc. The Children’s Partnership The Empowered Patient Coalition Well Spouse Association Lisa Fenichel, e-Health Consumer Advocate Mark Gorman, Patient Advocate Regina Holliday, Patient Advocate Mary Anne Sterling, Family Caregiver Advocate Page 16 Consumer Partnership for eHealth Request for Comment – Stage 3 Definition of Meaningful Use Summary of Recommendations ID Number Criterion Record Demographics SGRP 104 Level of Support Retiring this objective could have adverse effects on health disparities SGRP 112 Advance Directives Strongly support transitioning to core the criterion to record advance directive status for EHs Strongly support adding the criterion as a menu objective for EPs SGRP 115 Condition Reports and Patient Dashboards Fully support SGRP 204A Support accelerating the time frame for making information available to 24 hours Page 17 View/Download/Transmit (V/D/T) Recommendation If criterion is retired, HITPC should require the use of demographic data in both functional criteria and quality measurement (i.e., stratification and reporting of patient lists and CQMs by demographic data) Collection of sexual orientation/gender identity data should be mandatory Require collection of disability status data Require the content of an advance directive be accessible through the EHR Lower 65 year age limit to all adult patients (18 years & older) Certification criteria should require that the capture of this information is possible for any patient (regardless of age) Encourage advancement in future stages to strengthen disparities reduction efforts Advance threshold for the % of patients provided electronic access and the % of patients who use V/D/T Urge access to visit notes Shorten the time by which providers must make available lab results to 2 business days V/D/T using diverse and accessible technology platforms and in the patient’s preferred language Support exploring opportunities to leverage the automated Blue Button function to meet V/D/T Consumer Partnership for eHealth Request for Comment – Stage 3 Definition of Meaningful Use Summary of Recommendations criteria SGRP 204B SGRP 204D Patient-Generated Health Information Record Amendments SGRP 205 Clinical Summaries Page 18 Strongly support giving patients the ability to contribute information to their medical record Strongly support new criterion to provide patients with an ability to record an amendment Support clarification that clinical summaries should include information that is meaningful and Increase threshold criterion to at least 25 percent Specify categories of highvalue patient information that have greatest potential to significantly improve health, safety, and quality o Goals for care o Medication allergies and non-tolerated medications o Caregiver and additional professional care team member name(s), contact information, and role(s) o Family history o Functional limitations o Supports and services necessary for independent living o Patient values and preferences for care o Patient experience o Behavioral and mental health history o Identification of problems or concerns from the patient’s perspective o Psycho-social information o Data recorded by patient for monitoring of progress toward patient goals o Risk factors indicated by structured surveys N/A Encourage HITPC to work with clinicians and patients to determine the most helpful data elements to include in clinical summaries Consumer Partnership for eHealth Request for Comment – Stage 3 Definition of Meaningful Use Summary of Recommendations SGRP 205 Clinical Summaries (cont’d) (cont’d) actionable to patients SGRP 206 Non-English PatientSpecific Education Materials Fully support utilizing patient preference data to provide access to meaningful, useful education materials SGRP 207 Secure Patient Messaging Support SGRP 208 Communication Preferences Fully supports inclusion of a separate criterion to record patient communication preferences SGRP 209 Identifying Available Clinical Trials Support SGRP 302 Medication Reconciliation Strongly support the increase in the threshold for medication reconciliation to 50 percent Enthusiastically support supplementing medication Page 19 Consider developing guidance and resources promoting the use of plain language, standardized format, and graphic explanations Clarify measure denominator Modify the measure to include the top 5 nonEnglish languages spoken in the state where the EP/EH is located Allow secure messages sent and received by a family or other patientapproved caregiver to count towards the increased threshold Add criterion measuring timeliness of response from providers to their patients who use secure messaging Certification criteria should include capability to record caregiver communication preferences Require collection of communication preferences for at least the primary caregiver N/A Encourage threshold advancement for reconciliation of medication allergies and problems in future stages Engage patients and caregivers in information reconciliation o Medications actually taken (including over-the-counter Consumer Partnership for eHealth Request for Comment – Stage 3 Definition of Meaningful Use Summary of Recommendations SGRP 302 Medication (cont’d) Reconciliation (cont’d) SGRP 303 Summary of Care Record SGRP 304 Care Plans reconciliation for transitions of care with reconciliation of medication allergies and problems 30% threshold unacceptably low for summary of care records provided electronically Support addition of a list of care team members Support certification criteria which build capacity for longitudinal, shared care plans HITPC should more aggressively advance the capacity in Stage 3 of EHRs and HIE to support a comprehensive, interactive shared care plan platform drugs and herbal supplements) o Caregiver name, contact information, and role o Problems/complaints o Advance directive status and content o Additional care team members (primary care, specialists, ER, retail clinics, etc.) Significantly increase threshold to 80% of patients to have summary of care records shared, with no less than 65% transmitted electronically Require the inclusion of both patient-defined and clinical goals Require functional status and independent living services and supports at the point of transition or referral Advance concept of the longitudinal, shared care plan by requiring documentation of: o Cross-setting care team member list o Comprehensive patient goals o Psycho social assessment information Suggest threshold of 20 SGRP 305 Closing the Referral Loop Page 20 Fully support new criterion percent of all patients Encourage threshold advancement in future stages Encourage making information available to patients and family members through the patient portal Consumer Partnership for eHealth Request for Comment – Stage 3 Definition of Meaningful Use Summary of Recommendations N/A SGRP 308 Notice of a Significant Strongly support Healthcare Event Page 21
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