April 28, 2014 VIA ELECTRONIC SUBMISSION

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1 April 28, 2014 VIA ELECTRONIC SUBMISSION Karen DeSalvo, MD, MPH, MSc National Coordinator for Health Information Technology Department of Health and Human Services 200 Independence Avenue, S.W. Washington, DC RE: Proposed Rule Voluntary 2015 Edition Electronic Health Record Certification Criteria; Interoperability Updates and Regulatory Improvements Dear Dr. DeSalvo: The Federation of American Hospitals ( FAH ) is the national representative of investorowned or managed community hospitals and health systems throughout the United States. Our members include teaching and non-teaching hospitals in urban and rural America, including inpatient rehabilitation, long-term acute care, cancer and psychiatric hospitals. On behalf of our more than 1,000 member hospitals, we are pleased to offer the following comments on the Proposed Rule issued by the ONC titled, Voluntary 2015 Edition Electronic Health Record Certification Criteria; Interoperability Updates and Regulatory Improvements. General Comments The FAH has been, and continues to be, a strong supporter of the HITECH law. Our member hospitals recognize that interoperable Certified EHR Technology ( CEHRT ) can be a conduit for having the right information in the right place at the right time, resulting in better care for patients. CEHRT also can facilitate greater access to critical information for nonclinicians, empowering patients (and their caregivers) to assume a more active role in their healthcare. The FAH appreciates the intent of the Proposed Rule to provide a more incremental approach to rulemaking, thereby attempting to send more frequent signals to the field regarding 1

2 changes in functional requirements for CEHRT. We also believe this approach could provide additional lead time for vendors and providers to prepare for implementation of Stage 3 Meaningful Use. However, to maximize the benefit of this approach, voluntary certification criteria must be fully specified and testable for the HIT vendor community. The process must create a longer glide-path that is actionable on the part of vendors and providers. Compliance Timeline The FAH has consistently advocated for sufficient time for providers to implement CEHRT and meet regulatory requirements related to use of that technology to achieve Meaningful Use. We remain concerned that under the current Meaningful Use timeline, providers are constantly implementing technology, with no time to work on actually using the data generated by the technology to improve care or support delivery system reforms. Given providers challenging experience with the roll-out of the 2014 Edition CEHRT, we are further convinced the current regulatory construct of two years in each stage is a barrier to fully realizing the core goals of the Meaningful Use Program to improve the quality, safety and efficiency of healthcare provided to patients. We have heard significant concerns from our member hospitals related to implementation of 2014 Edition CEHRT including HIT vendor delays in upgrades and software releases and lack of vendor resources to support functionality and standards. These challenges have created a ripple effect which impacts all of the extensive post upgrade work providers must undertake in order to meet Meaningful Use objectives. The compressed timeline also has clearly proven difficult for HIT vendors, which have often lacked the resources to fully support software upgrades and implementation for their customers, resulting in sub-optimal workflows (i.e., the product works as designed but the design itself is flawed). Under the current timeline, when providers implement a vendor product it is generally cost and time-prohibitive to switch to a new vendor. Even within a single vendor s suite of products, switching from one product to another is extremely difficult. Ultimately, eligible providers are the only entities assuming actual risk for the products they implement to meet Meaningful Use whether for lost incentives or payment penalties. We appreciate that certain mid-course corrections have been made to the timeline, including an additional year in Stage 1 for providers who first attested in 2011 and the recent announcement that providers attesting to Stage 2 in 2014 would remain in Stage 2 for a third year, through However, this one year extension of Stage 2 does not address the multitude of challenges providers are facing meeting Meaningful Use this year. To ensure providers do not fall off the Meaningful Use escalator in 2014, we urge CMS and ONC to extend the 2014 reporting period to give providers additional time to meet Meaningful Use requirements, earn incentive payments and avoid penalties. Specific Comments I Edition Certification Criteria Implantable Devices/Unique Device Identifier ( UDI ) The FAH supports the ONC s proposal to create a field in certified EHRs to list the UDIs of implanted devices. We believe it is critical to ensure there is a standard for recording this information to prevent creating new documentation requirements. 2

3 Currently, the ONC proposes only to require automatic identification and data capture ( AIDC ) capabilities such as barcoding in The FAH believes there would be value in requiring at least one form of AIDC in Absent any AIDC capabilities, clinicians would have to manually enter the UDI into each EHR which could result in data entry errors and create workflow inefficiencies. II. Non-Meaningful Use EHR Technology Certification Non-incentivized providers, including post-acute providers, are critical partners in the healthcare continuum. To achieve the triple aim of better health, better care and lower costs, patient information must follow the patient, whether in an inpatient, outpatient or post-acute setting. We appreciate the ONC s recognition that to enable interoperability across care settings, the Certification Program should be expanded to consider the needs of all providers, not only those eligible for the EHR Incentive Program. Non-incentivized providers essentially have been pulled into the HITECH framework without the benefit of being eligible for incentive payments and pulled into a market where the presence of incentive funds has significantly increased the cost of EHR adoption. In the shortterm, it could be possible that a separate certification for non-meaningful Use products would reduce cost and complexity and provide benefit to non-incentivized providers adopting health IT systems. However, in the fairly near future, incentive payments will not be the driver of adoption and use of health IT, resulting in far less distinction between Meaningful Use and non- Meaningful Use providers. Therefore, the drivers of certification likely will be universal needs across all providers enabling transitions of care, ensuring privacy and security, and addressing the complexities of behavioral health information. It is critical that ONC understand which aspects of certification would most benefit non-incentivized providers and not make assumptions about differences in technology needs between Meaningful Use and non-meaningful Use providers. For example, numerator and denominator calculation may, in fact, be useful to non- Meaningful Use providers for patient safety tracking and other purposes. III Edition Certification Criteria In general, we urge the ONC to consider the value proposition for any new certification criteria, particularly those that would require significant add-on costs for hospitals and other providers. View, Download, and Transmit to a 3 rd Party FAH member hospitals are committed to providing patients with timely access to their health information and have generally implemented (or are in the process of implementing) patient portals to operationalize this access. The ONC is considering a requirement in 2017 to include images as part of the view, download and transmit certification criterion. The FAH urges the ONC to consider the value proposition (cost vs. benefit) of this addition both for patients and for referring providers. Is having the image necessary or does the report contain the information that a third party would need to know? We are concerned that making images available without clinician interpretation could be confusing to patients and result in security issues and/or redundant image storage which would drive up costs for providers. 3

4 Additional Patient Data Collection In today s world of mobile apps and fitbits a growing number of individuals are generating a wealth of information about their physical and mental health. With the growing imperative to encourage and enable greater patient engagement, it is critical to determine how to effectively utilize patient-generated data and information and incorporate it into the patient record. However, there are a number of complexities to consider related to this potential requirement, including potential legal issues resulting from the incorporation of patientgenerated data into an EHR and the potential burden on providers to assist patients in submitting their health information. Duplicate Patient Records The FAH supports a requirement for EHRs to have the capability to identify and correct potential duplicate patient records. In the absence of a unique identifier or other universal mechanism, patient identification and record matching remains a challenge for providers. Ensuring that all relevant information needed to care for a patient is accessible to providers is a serious patient safety issue. Implantable Devices/UDI Building on the 2015 voluntary criterion, this proposal would create data fields in certified EHRs to list information beyond the UDI. These fields would contain information including the device manufacturer, model, single-use indication, whether it contains latex and MRI safety status. The proposal also would have these fields automatically populated by an external database. Including these data in the EHR would prevent clinicians from having to manually enter the UDI into an external database as well as allow hospitals to identify all patients using a certain type of device. Additionally, we support the proposed capabilities to ensure that UDIs can be transmitted to registries (and other reporting systems) that collect data on the devices used in clinical care to assess quality and patient outcomes. Certification Policy for EHR Modules and Privacy and Security Certification Criteria The FAH supports the HIT Standards Committee recommendation that certification for privacy and security criteria be based on demonstrating that the EHR Module meets the required functionality (or that the criteria are not applicable to that module). Blue Button Prior to adopting a separate certification criterion for Blue Button, we would encourage the ONC to assess what additional benefits Blue Button brings beyond the functionality of current patient portals. ****** 4

5 The FAH appreciates the opportunity to comment on this Proposed Rule and look forward to continuing to work with the ONC moving forward to ensure the technology needs of hospitals and other providers are appropriately addressed through the HIT Certification Program. If you have any questions about our comments or need further information, please contact me or Samantha Burch of my staff at (202) Sincerely, 5

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