March 12, Attention: HIT Policy Committee Meaningful Use Comments. CMS-0033-P, Proposed Rules, Electronic Health Record (EHR) Incentive Program

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1 March 12, 2010 Charlene Frizzera Acting Administrator U.S. Department of Health and Human Services 200 Independence Ave., SW, Suite 729D Washington, DC Attention: HIT Policy Committee Meaningful Use Comments Re: CMS-0033-P, Proposed Rules, Electronic Health Record (EHR) Incentive Program Dear Ms. Frizzera: The Children's Partnership is a 15-year old nonprofit policy and strategy center, with offices in Washington, DC and California, working to improve the health of children and to improve their educational achievement, economic opportunities, and health outcomes through effective use of the Internet and other technology tools. A key focus of our research and policy development is the potential for health information technology (HIT), if properly deployed, to support the transformation of our health care system into one that is more patient-centered and that promotes higher quality, coordinated, costeffective care that is designed to produce better health outcomes for all, including America s 74 million children. The Children s Partnership is currently participating in a number of panels relevant to the Health Information Technology for Economic and Clinical Health Act (HITECH) of the American Recovery and Reinvestment Act (ARRA), including the Privacy and Security Policy Workgroup of the federal HIT Policy Committee and California s ehealth Technical Advisory Committee. The HIT incentives, and particularly the meaningful use provisions, of ARRA offer a tremendous opportunity to drive such system improvements. We applaud the considerable work that went into developing the Proposed Rules (CMS-0033-P) and the real involvement of interested stakeholders, including consumers. We appreciate the emphasis on patient and family engagement and population and public health, the inclusion of meaningful use criteria specifically designed to improve care for children, as well as the recognition of the importance of privacy and security. We also appreciate the fact that these Proposed Rules set a floor for Medicaid programs, but allow States to go beyond that floor in ways that may be appropriate to the needs and circumstances of their residents. Nevertheless, there are a number of opportunities to strengthen the rules as they relate to children s health in the development of Stage 1 meaningful use criteria and that we address below in the order presented in the Preamble (not by order of priority). Improve Quality, Safety, Efficiency and Reducing Health Disparities This first goal - improving quality, safety, efficiency, and reducing health disparities - is laid out in the Proposed Rules in a manner that includes many strong objectives and builds upon a laudable set of care goals. However, to ensure that these rules achieve their stated goal for children, we recommend the following:

2 Page 2 1. Recording Demographics: We endorse the requirement that eligible professionals (EPs) and eligible hospitals record complete patient demographic data, including date of birth. ( 495.6(c)(5)) Date of birth enhances the precision of quality measurement for young children. Furthermore, such complete data collection and its ultimate use will be essential to ensure that HIT improves care for vulnerable populations rather than further increasing disparities through uneven implementation. As such, we urge CMS to lay out strong objectives and measures that require the use of such demographic data in quality measurement as well as require providers to break out lists of patients by specific conditions ( 495.6(c)(9)) by patient demographic characteristics, to help providers reduce disparities in the care they provide. Implicit in this comment is support for CMS decision to require hospitals, as well as EPs, to generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, and outreach. However, we believe CMS should go the extra step to require these lists to be broken down by characteristics that allow for useful evaluation of population health along different dimensions. 2. Facilitate Linkage Between EHR and Full Birth/Death Information: The Proposed Rules ask for comments on how States and hospitals could work together to facilitate a linkage between the EHR and the full birth and death certification information. We support your working on this further and would suggest that CMS require the capture of such information as a Stage I objective, in line with other Stage I data-capturing objectives. Continued coordination with the Agency for Healthcare Research and Quality (AHRQ) on this matter will be of value, as will work with the Office of the National Coordinator (ONC). In fact, CMS could urge ONC to include the development of such linkages as a priority in its work as part of the Federal Health Architecture and in approving HIE plans under Section 3013 grants. To be of the greatest value, an EHR should provide a comprehensive picture of health over time, accessible to appropriate individuals when they need it. As such, birth certificate information would be of great value as part of the health record from the moment of birth and throughout life. Further, requiring such linkage could facilitate the development of beneficial data linkages with public health agencies and supporting infrastructure. 3. Record and Chart: TCP strongly supports CMS decision to modify the HIT Policy Committee recommendation to require that electronic growth charts for children plot and display height, weight, and BMI, by age. ( 495.6(c)(6)(i)(C)) These measurements are important indicators of child health and the visual display of such information is an important tool in a pediatric provider s toolbox. We therefore recommend that CMS not only retain the objective to plot and display growth charts for children, but also expand this recommendation as follows: a. Apply the objective to all children, including those younger than age 2. We are concerned by the fact that the requirement is limited to ages 2-20, excluding an important cohort for which growth information is especially important (ages 0-2). In fact, including newborns growth charts in the EHR is especially valuable in terms of promoting coordination of care, given the transitions among caregivers that occur at birth. Furthermore, the CDC site that is mentioned in the discussion of the issue (pages 1855 and 1856, specifically includes visually displayed/plotted growth charts for ages 0-2 among their models. While we acknowledge that BMI is not relevant for infants aged 0-2, we also agree with CMS, as noted in the Preamble, that BMI itself does not provide adequate information for children. Including early growth charts at this point will drive the development of EHRs in the optimal direction and promote the thrust of Stage 1 criteria: moving providers toward capturing essential data in electronic form.

3 Page 3 Accordingly, we recommend that the objective be further modified to require plot and display growth charts for children 0-20 years old, including BMI for children 2-20 years old. b. Include a measure of providers follow-up on growth chart information where clinically indicated. In addition, we are concerned that the Stage 1 criteria do not require follow-up where indicated by the plotted and displayed growth chart. In the clinical quality measure laid out for adults, BMI screening and follow up are required (Table 7, page 1892) and we would urge CMS to establish a similar standard for treatment of children (Table 11, page 1893), whose conditions can be identified through abnormal growth patterns and/or whose life-long weight trajectory and related preventable health conditions can be positively influenced by such early intervention. 4. Smoking Status: While it may be appropriate to focus questions about smoking status on patients 13 years old or older, younger patients can also have significant smoking-related exposures that should be discussed in a visit with health providers. These could include a younger child smoking his/herself or, more likely, it could include living with a smoker. Whatever the exposure, it is an important part of the record, both in terms of the individual child s health as well as building the record for future research and studies of population health. We would recommend that CMS change objective 495.6(c)(7)(i) to record smoking exposure, including patient s smoking status or routine second hand exposure, irrespective of age. Such a change would encourage discussion of the detrimental impact of smoking in the patient visit, arguably the most important part of this objective. Including younger children in these conversations would increase the impact of that discussion. 5. Patient Reminders: Patient reminders provide a valuable opportunity to encourage appropriate preventive/follow-up care, especially where delivered according to the patient s preference. We were highly disappointed when we found that this valuable objective had been limited to patients age 50 and up in the measures. ( 495.6(d)(4)(ii)) As we all know, children benefit immensely over the life course when they receive recommended preventive and follow-up care. Accordingly, we would urge CMS to prioritize reminders for children in establishing the meaningful use criteria. Doing so would promote one of the primary goals of these provisions -- population health -- by engaging children, parents, and caregivers in attaining recommended preventive care. In fact, to gain even more value from patient reminders, CMS should consider promoting the use of reminders that focus on particular chronic conditions, such as asthma. Even so, all patients should benefit from this new electronic tool, not just chronically ill individuals and not just adults over age Five Clinical Decision Support (CDS) Rules: We support the requirement to implement five CDS rules relevant to a provider s specialty or of high clinical priority. ( 495.6(c)(10)) We recommend this requirement be further clarified to specify that providers who care for both children and adults include among the five rules they implement at least one that is relevant for children. We also recommend that where CMS provides examples of appropriate and useful CDS rules, it should include some relevant to children s care such as the AHRQ pediatric rules and reminders tools available for download at: ode=2&userid=8959.

4 Page 3 7. Check Insurance Eligibility: We support the decision to delete where possible from the requirement to check insurance eligibility electronically from public and private payers. ( 495.6(c)(11)) This objective is achievable and access to health care for vulnerable populations depends on their providers having real-time access to eligibility information. Engage Patients and Families We applaud CMS for prioritizing patient and family engagement in these Proposed Rules. True transformation of our health care system will require engaging patients, families, and caregivers in their care in new and meaningful ways. However, to ensure that this goal is met, a number of issues require further clarification: 1. Disclosure of Information: The Proposed Rules specifically defer to existing Federal and State law regarding disclosure of information to minors, their parents, and their guardians, in setting the rules for meaningful use. We agree with this stance and request that CMS clarify that such deference is true generally, not solely with respect to disclosure of information to minors, their parents, and their guardians. In other words, CMS should clarify that nothing in the meaningful use rules alters Federal or State law related to uses and disclosures of protected health information. We also recommend that CMS work with ONC, the HIT Policy Committee, and its Privacy and Security Policy Workgroup to clarify and reconcile inconsistencies and gaps in Federal and State laws regarding the protection of sensitive information, where possible, since such resolution will be important to attaining meaningful use for affected populations. Furthermore, we endorse the HIT Policy Committee s recommended changes to the Privacy & Security criteria to shore up these provisions. 2. Electronic Copy/Electronic Access: In order to successfully involve patients and families in their own care, it is important that effective means are deployed to provide them with their health information. We believe this is the intent of the Proposed Rules but would like to see further clarification in the final rule, including definitions of the terms electronic copy and electronic access as used in Specifically, we recommend that CMS clarify the rules to require providers to establish a means for consumers to be able both to view the information that providers have about them and their care and to obtain a copy of that information. Both the viewing and copies of the information should be made available in a timely and affordable manner and copies should be made available in a format that the consumer prefers so that the information is portable and usable. In defining these requirements, CMS should ensure that the end result does not simply mirror the paper-based record system in electronic form (e.g., through static electronic copies), but that it provides the consumer with a dynamic, integrated set of records that they can use. To ensure that a patient can realize the benefits of this opportunity, we recommend that CMS require providers to demonstrate that they have informed their patients about how they can access and obtain a copy of their information in accordance with this requirement. 3. Patient-Specific Education: We agree with the statement in the Preamble that patient-specific education is a critical component of patient engagement and empowerment (p. 1857). Therefore, we believe it is an error to remove that objective from the Stage 1 criteria. We recommend that CMS retain this objective and provide incentives in the Stage 1 criteria to integrate appropriate knowledge resources that already exist into EHRs, such as those provided by the American Academy of Pediatrics. We also recommend that CMS and ONC encourage the development of increasingly sophisticated knowledge resources designed to meet diverse patient needs, such as culturally and linguistically appropriate materials, and build requirements

5 Page 5 regarding such resources into the Stage 2 criteria. For example, in this staged approach CMS could adopt a Stage 1 objective to provide patients with relevant electronic resources and a Stage 2 objective to incorporate linkages to patient-specific resources into the EHR, at the appropriate literacy level. We also recommend that CMS work with ONC to direct the HIT Extension Program, including the Regional Extension Centers, in supporting this objective. While we welcome CMS intent to work with the HIT Policy Committee and the National Library of Medicine and other experts on this issue, we believe it is important to send the message to vendors at this early stage to build in the capability to link with such resources. At a minimum, CMS should use this opportunity to put stakeholders on notice that this will be added as a Phase 2 objective. 4. Discharge Instructions: We believe that hospitals should offer a patient their discharge instructions in their preferred format, including an electronic format that is easily viewed and portable (as discussed above in comment (2)). The current language, by stating that this is dependent upon patient s request, would appear to undermine the guarantee that such information is made available to all patients. ( 495.6(e)(4)) Improve Care Coordination The Children s Partnership welcomes CMS efforts to use this HIT opportunity to improve care coordination, which can lead to more efficient, more effective, patient-centered care. In the interests of making the most of this opportunity for children, we recommend: 1. Exchanging Key Clinical Information: While this objective is well constructed and will greatly enhance coordination of health care ( 495.6(d)(8) and (e)(5)), we would ask that CMS specifically clarify that patient authorized entities can include patient-designated non-clinical providers, such as schools and foster care case workers, in addition to those already mentioned in the Preamble (insurance companies and PHR vendors). In fact, children and others will benefit immensely from secure information sharing that increases coordination between the various agencies and non-health providers that serve them. Such capability in the EHR will support care of the whole child/person and promote their health. 2. Medication Reconciliation: Regarding the important objective to perform medication reconciliation at relevant encounters and each transition of care ( 495.6(c)(13)), we are concerned that the requirement should additionally specify that the results of the reconciliation be captured and appropriately shared. At a minimum, such information should be made available to the patient (e.g., as part of their summary of care record and discharge summary) and should become a part of their EHR, upon being done, thus becoming available for better selfmanagement and care coordination. Improve Population and Public Health HITECH is an important opportunity to optimize the value of emerging HIT for the improved health of the population, as well as for the individual patient. Children have the most to gain from building this knowledge base over the long term. However, without a major federal investment in the public health infrastructure, the new HIT will not attain its full capability. 1. Submit Data to Immunization Registries: Because the current public health information technology infrastructure is not universally prepared to support electronic exchange of immunization data, CMS has appropriately qualified the relevant immunization-reporting objective with where required and accepted. ( 495.6(c)(15)) However, we strongly urge CMS to work with ONC, the Centers for Disease Control and Prevention (CDC), States, and

6 Page 6 others to strengthen the public health IT infrastructure so that such electronic exchange is more widely available and the capability required under the rule can be increasingly utilized over time. We believe that meaningful use of these data will also be advanced through the opportunity that states have under these Proposed Rules to apply more stringent requirements where they have the necessary infrastructure and laws in place. Reporting of Clinical Quality Measures We understand that CMS has tried to strike a reasonable balance in allowing attestation of summary information regarding clinical quality measures while the infrastructure for reporting is developed. We would urge CMS to ultimately require electronic reporting of information in a manner that allows for rigorous evaluation of population health along the various dimensions that are being recorded per Stage 1 objectives (date of birth, race, ethnicity, insurance status, etc.). Recording such demographic information per Stage 1 requirements will set the stage for Stage 2 analysis of quality as experienced in different populations and will advance efforts to address disparities and the unique needs of children and other vulnerable populations. In further defining the measures, CMS should prioritize measures that require clinical rather than administrative data, since this capability is one of the main benefits of EHRs. In that vein, we support the inclusion of measures for additional clinical areas, such as pediatrics, long-term care, obstetrics, dental/oral health, mental health and substance abuse in the Stage 2 definition. Conclusion The ARRA specifically directs ONC and States to address children and other populations with unique needs in HIT efforts, including regarding meaningful use. Specific attention to children is essential if we are to realize the stated goal of these HIT efforts, not only because such efforts will improve children s health, but also because many prevalent and costly adult-onset conditions have their origins in childhood. As the terms of meaningful use are being defined, there is a parallel process underway to design the model pediatric EHR format for children enrolled in Medicaid and CHIP, pursuant to the Children s Health Insurance Program Reauthorization Act of 2009 (CHIPRA). We hope that the results of this childfocused effort would ultimately be incorporated into the meaningful use process, just as CMS has attempted to reconcile the meaningful use objectives and measures with the Children s Healthcare Quality Measures being designed pursuant to CHIPRA. Coordination of these and other federal HIT initiatives will help ensure that developing HIT meets the needs of children and that the desired transformation of health care is achieved for all, including all children. If you would like to discuss any of these suggestions further or learn more about our work, please contact me at (510) or tshaw@childrenspartnership.org. Sincerely, Terri Shaw Deputy Director!