June 15, 2015 VIA ELECTRONIC SUBMISSION

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1 Charles N. Kahn III President & CEO June 15, 2015 VIA ELECTRONIC SUBMISSION Andrew M. Slavitt Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-3311-P 200 Independence Avenue, SW Room 445-G Washington, DC Re: Medicare and Medicaid Programs; Electronic Health Record Incentive Program Modifications to Meaningful Use in 2015 through 2017; 80 Fed. Reg (April 15, 2015) Dear Acting Administrator Slavitt: 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, I am pleased to submit the following comments regarding the Centers for Medicare & Medicaid Services ( CMS ) Electronic Health Record ( EHR ) Incentive Program Modifications to Meaningful Use in 2015 through 2017 proposed rule ( Proposed Rule ) for eligible professionals ( EPs ), eligible hospitals and critical access hospitals ( CAHs ) th Street., NW, Suite 600 Washington, DC FAX

2 I. GENERAL COMMENTS The FAH 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 non-clinicians, empowering patients (and their caregivers) to assume a more active role in their health care to achieve patientcentered care. Hospitals recognize that these goals only will be realized as their large-scale investments accrue over time. We are committed to working with CMS and the Office of the National Coordinator ( ONC ) for Health Information Technology ( HIT ) to achieve these objectives. While there are numerous challenges to overcome in the years ahead, we believe the federal government s investment in HIT presents a tremendous opportunity to assist in the transformation of our health care system for clinicians, hospitals, and above all, patients. As hospitals commence with preparing to meet Stage 3 of the EHR meaningful use requirements, we urge CMS to help ease this transition by alleviating unnecessary burden on hospitals and other providers. We appreciate and strongly support certain proposals in the Proposed Rule that assist hospitals in these transition efforts, for example, the 90-day reporting period for To further support hospitals in these transition efforts, we urge CMS not to implement certain proposals in the Proposed Rule that change the rules midstream without adequate time for hospitals to implement them, such as requiring hospitals to implement electronic prescribing ( erx ) under Stage 2 as of January 1, 2016, as discussed further below. In addition to these general comments, below we describe in more detail our views and recommendations regarding specific provisions in the Proposed Rule that the FAH supports, as well as those with which we have significant concerns. We urge CMS consideration of these comments as it develops a final rule. II. SPECIFIC COMMENTS A. The FAH Supports the 90-Day EHR Reporting Period for 2015 The FAH appreciates and strongly supports CMS proposal to change the EHR reporting period in 2015 to a 90-day reporting period instead of the current requirement for a full year. This change will be extremely helpful to providers who are doing their best to work with EHR vendors and make the workflow adjustments needed to meet meaningful use requirements. We urge CMS to finalize this proposed 90-day EHR reporting period for 2015 as soon as possible. CMS proposes to change the definition of EHR reporting period beginning in 2015 so that it aligns with the calendar year for both EPs and hospitals. More specifically, for 2015, CMS proposes that hospitals may begin an EHR reporting period as early as October 1, 2014 and end by December 31, 2015, and an eligible hospital must attest to the 2015 EHR reporting period 2

3 between January 1 and February 29, The FAH does not oppose CMS proposal to align the EHR reporting period with the calendar year. In fact, we believe this change will be helpful in aligning EP and hospital efforts to meet EHR meaningful use requirements. As noted below, however, we have significant concerns regarding the attestation timeline. B. The FAH Supports Dropping Certain Redundant, Duplicative or Topped Out Measures The FAH supports CMS proposal to drop certain redundant, duplicative, or topped out measures. We believe this will have the effect of simplifying the EHR meaningful use program and easing the administrative burdens associated with the attestation process. It also will reduce the potential for providers to report on measures for reporting sake, while promoting meaningful reporting that leads to better quality of care for patients. C. The FAH Supports Reducing the View, Download and Transmit Threshold Related to Patient Electronic Access The FAH strongly supports the proposed reduction in the threshold for Measure 2 under the objective for Patient Electronic Access. Under the proposed change, at least one patient seen by an EP during the EHR reporting period (or their authorized representative) would be required to view, download, or transmit his or her health information to a third party. Similarly, at least one patient who is discharged from the inpatient or emergency department of a hospital would be required to view, download, or transmit to a third party his or her information during the EHR reporting period. This would replace the current threshold of more than 5 percent of unique patients seen by an EP or discharged from the inpatient or emergency department of a hospital during the reporting period. This change would recognize appropriately the challenges involved in encouraging patients to avail themselves of accessible information and the fact that providers have little or no control over patient behavior, especially their use of electronic means to access their health information. Notwithstanding our support for this change, we recognize that there is a potential risk that the more relaxed requirement could lead to backsliding on the part of providers. However, given CMS intent to increase the measure threshold for Stage 3, we believe that providers should be put on notice that they need to make continued progress in patient use of portals and other electronic means for accessing health information. D. The FAH Supports More Flexibility in Transmitting a Summary of Care The FAH also supports the proposed change affecting the Summary of Care objective, under which the provider is given more flexibility with respect to the electronic means for transmitting a summary of care record. In the proposed rule, CMS notes that this change reflects stakeholder input regarding operational challenges in meeting the current measure. We appreciate CMS s recognition of these challenges. 3

4 E. The erx Requirement Should Remain Optional Until Stage 3 is Implemented CMS proposes to convert the Stage 2 erx Objective for hospitals from a menu objective to a required one, beginning in More specifically, more than 10 percent of hospital discharge medication orders for permissible prescriptions (for new, changed and refilled prescriptions) would need to be queried for a drug formulary and transmitted electronically using CEHRT. CMS further proposes that hospitals could claim an exclusion for this measure if for an EHR reporting period in 2015 they were either scheduled to demonstrate Stage 1 (which does not have an equivalent measure) or scheduled to demonstrate Stage 2, but did not intend to select the Stage 2 erx menu objective for an EHR reporting period in Therefore, effectively, most hospitals would be required to implement erx by January 1, We urge CMS to ensure that the hospital erx measure remains optional for all three years (2015 through 2017), or until Stage 3 is implemented if it is further delayed. Requiring hospitals to implement an erx system in only a few months, by January 1, 2016, without any previous notice of the requirement is impractical, if not impossible. To allow sufficient time for implementation, this requirement should be implemented as part of Stage 3. Implementing erx cannot be accomplished at the flip of a switch. ERx for hospital discharges was a menu option under Stage 2, but many hospitals did not choose it as a menu option under Stage 2 because the rule was finalized in September of 2012, which as a practical matter was too late for implementation under Stage 2. Since erx was a Stage 2 menu option, hospitals have been in the planning stages to implement erx for purposes of Stage 3. Yet, the Proposed Rule now changes the rules midstream, and requires hospitals to implement in an extremely abbreviated time period a very complex program. Specifically, hospitals would have to contract with a third party vendor to process the script, or the hospital s CEHRT vendor would contract with another vendor to do so. This process takes time, and it is unclear whether these vendors have the capacity to contract with hospitals, and have available resources to assist in implementation of an erx system in hospitals across the country, within only a few months by After the vendor contracts are negotiated, an effective erx functionality must be developed for each hospital, including the ability to verify insurance coverage and process and transmit prescriptions. Vendors also conduct their own certification process (separate from ONC certification). Further, the erx systems need to be piloted across various hospitals to ensure that prescriptions are handled in a safe and effective way, e.g., ensure that scripts do not get lost in the system and that they can be transmitted correctly to the proper pharmacy. The system then needs to be rolled out across an entire hospital system. For large hospital systems this means rolling out new systems across many hospitals, along with training and education for potentially many thousands of employees. Also, different systems may need to be rolled out across different hospitals within a hospital system which contracts with multiple EHR vendors. All of the foregoing arrangements also have an associated financial burden. For example, hospitals incur fees in contracting with a third party vendor, along with transaction fees to process the scripts, including multiple transactions (and therefore multiple fees) per script. CMS should recognize that many, if not most, hospitals had not planned to meet the erx measure in 4

5 2016 as it currently is part of the menu set, and thus had not budgeted for these added costs at this time. Further, since many, if not most, hospitals do not have any experience with erx for discharge medication orders, the proposed threshold of more than 10 percent of discharge medication orders would be daunting. Many hospitals that have already met Stage 2 could not do so in 2016 if erx were required in With the challenges of Stage 3 on the horizon, hospitals have been engaged actively and aggressively in a planning process to advance their EHR capabilities over time, including erx. In light of these challenges, we urge CMS not to suddenly change the rules and create even more, and unexpected, last-minute challenges for hospitals in In sum, the FAH strongly urges CMS to defer mandatory hospital erx for discharge medication orders for as long as possible, preferably until after 2017, as part of Stage 3. F. CMS Should Provide a Longer Meaningful Use Attestation Timeline As noted earlier, for the 2015 reporting period, CMS proposes that providers would need to attest to meaningful use by February 29, However, they would not be permitted to attest any earlier than January 1, The FAH has several concerns regarding the attestation timeline. First, for purposes of the 2015 EHR reporting period, we do not believe two months is a sufficient length of time for all hospitals and EPs to attest. Second, we are concerned that CMS attestation system would not have the capacity to accept and process attestations from all hospitals and EPs that would be submitting their attestations at the same time, and during such a short timeframe. Similarly, for purposes of the 2016 EHR reporting period, a two-month attestation period likewise would be inadequate. In general, we believe that a three- or four-month attestation period is needed. Third, as CMS recognizes, being unable to attest prior to January 1, 2016 will mean that some providers will inappropriately incur payment adjustments early in 2016 even though they will subsequently attest to being meaningful EHR users for the first time during We understand that these payment adjustments would subsequently end, and payments to the affected providers would be reconciled, but we do not consider this sufficient, as it would cause substantial administrative and financial burden for providers and CMS. We, therefore, urge CMS to find some means to accommodate providers participating in the EHR meaningful use program for the first time so they can avoid payment adjustments early in FY or CY Providers should not have to experience cash flow problems, even for only a relatively short period of time, when they already have met EHR meaningful use requirements. G. CMS Should Not Finalize the Bidirectional Data Exchange Requirement for Immunization Registry Reporting, and Should Broaden the Exclusion Policy for Public Health and Clinical Data Registry Reporting CMS proposes to adopt consolidated public health reporting objectives for all providers for an EHR reporting period in 2015 through CMS further proposes that a provider would need to be in active engagement with a public health agency ( PHA ) or clinical data registry ( CDR ) to submit electronic public health data in a meaningful way using CEHRT, except where prohibited and in accordance with applicable law and practice. Active engagement 5

6 could be demonstrated by any of the following options: completed registration to submit data; testing and validation; and, production. In addition, hospitals would be required to choose from six available measures (Immunization Registry Reporting, Syndromic Surveillance Reporting, Case Reporting, Public Health Registry Reporting, CDR Reporting, and Electronic Reportable Laboratory Result Reporting) and successfully attest to any combination of three measures; the Public Health Registry and CDR Reporting measures could be counted more than once if more than one public health registry or CDR is available (and thereby count toward the three measures that must be satisfied). However, CMS also proposes that an exclusion for a measure would not count toward the total of three measures. Also, for 2015 only, hospitals scheduled to be in Stage 1 that year would be required to satisfy at least two measures (not three) unless they can either (1) exclude from all but one available measure and report that one measure; or (2) can exclude from all available measures. Although the FAH supports the proposed substitution of active engagement for the current ongoing submission requirement, and the increased flexibility granted to hospitals that could now choose from among six available measures, we have concerns regarding certain elements of the CMS proposal. First, we strongly object to the requirement for bidirectional data exchange under the Immunization Registry Reporting measure. This functionality is not widely available and this factor alone could make it impossible for providers to meet the measure. We note that the proposed exclusions do not appear to account for a scenario under which the only impediment is inability to do bidirectional information exchange, either on the part of a PHA or on the part of the provider. The FAH believes it is premature to add a bidirectional information exchange requirement to the measure, and urges CMS to remove it in the final rule. The FAH also has major concerns regarding the proposed exclusions policy, under which an exclusion for a measure would not count toward the total of three (or, in some cases, two) measures that a hospital would need to meet. For example, under this policy, a hospital could be forced to report to a CDR even though such reporting would be of little value (because, for example, a given CDR might have limited relevance for only a tiny fraction of the hospital s patient population) and might involve considerable cost to the facility, including paying fees imposed by a CDR. Further, this policy is especially problematic for 2015, which largely would be over prior to publication of a final rule, and for 2016, which will begin shortly after publication of the final rule. Providers need time to budget for activities relating to EHR meaningful use, including PHA and CDR reporting, and they have not been expecting the need to consider the possibility of Case Reporting, Public Health Registry Reporting, or CDR Data Registry Reporting, since none of these were required under the current Stage 2. Further, while CMS has promised to make available a repository of information regarding PHA and CDR readiness to accept various types of data, such repository will not be available in the near-term, and even is not likely to be available before the start of the 2017 EHR reporting period. Thus, the FAH strongly urges CMS not to finalize the proposed exclusion policy for Public Health and CDR Reporting. In other words, if a hospital is able to meet exclusions for three of the Public Health and CDR Reporting measures, that should suffice for purposes of 2015, 2016 and

7 ********************** The FAH appreciates the opportunity to comment on this Proposed Rule regarding modifications to meaningful use in 2015 through 2017, and we look forward to continuing our work with CMS and the ONC moving forward. If you have any questions about our comments or need further information, please contact me or Katie Tenoever of my staff at (202) Sincerely, 7