Re: Medicare and Medicaid Programs; Electronic Health Record Incentive Program Stage 3 (CMS-3310-P)

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1 May 29, 2015 Mr. Andrew Slavitt Acting Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert H. Humphrey Building, Room 445 G 200 Independence Avenue, SW Washington, DC Re: Medicare and Medicaid Programs; Electronic Health Record Incentive Program Stage 3 (CMS-3310-P) Dear Acting Administrator Slavitt: The American Society for Nuclear Cardiology (ASNC) appreciates the opportunity to comment on proposed Stage 3 requirements, as published March 30, 2015 in the Federal Register, all eligible professionals (EPs) must achieve to meet electronic health record (EHR) meaningful use and avoid payment penalties beginning in ASNC is the international leader in education, advocacy, and quality in cardiovascular imaging, with more than 4,500 members worldwide. ASNC s membership is composed of cardiologists, radiologists, physicians, scientists, technologists, imaging specialists, and other professionals dedicated to the science and practice of nuclear cardiology. Widespread adoption of EHRs and their interoperability harbor great promise in improving patient safety, health care quality, care coordination, and practice efficiency. Cardiology practices in increasing numbers have embraced health information technology and its role in the delivery of medicine. The defining line, however, in provider satisfaction of EHR use is the distraction of meaningful use requirements that are more about counting and checking boxes than optimizing care delivery and improving outcomes despite CMS intended goals. ASNC applauds CMS for taking important and aggressive steps in the Stage 3 proposed requirements to streamline the meaningful use program by moving to a single stage of meaningful use and condensing the meaningful use objectives from 17 core and six menu objectives in Stage 2 to eight proposed objectives for Stage 3. The Stage 3 requirements also offer some flexibility to providers for meeting program objectives. We are also grateful that CMS is proposing to ease the burden of meaningful use on providers for 2015 through 2017 by allowing a 90-day continuous reporting period again in 2015 and by creating a better glide path to Stage 3 with its proposed Stage 2 modifications.

2 Despite these proposed improvements, we are concerned with proposals to require full-year reporting in 2017, to increase in some cases significantly measure thresholds, the continued use of patient engagement measures for which providers lack control, and increased requirements for health information exchange (HIE) despite lack of interoperability among EHRs. The recently enacted Medicare Access and CHIP Reauthorization Act of 2015 will usher in a new Medicare payment system for physicians beginning with the implementation in 2019 of a single Meritbased Incentive Payment System (MIPS) quality program that will replace Medicare s current multiple quality reporting programs. We strongly encourage CMS to consider the burden physician practices will face in meeting a new meaningful use program (Stage 3) in 2018 and then becoming acquainted with new MIPS program requirements in 2019, which will incorporate EHR meaningful use. Because Stage 3 of meaningful use would only exist as a stand-alone program for a single year, ASNC encourages CMS to extend its modified meaningful use plan for to also include ASNC is pleased to offer the following comments on several proposed Stage 3 meaningful requirements: EHR Meaningful Use Reporting Period CMS is proposing to change the definitions of the EHR reporting period for EPs such that a reporting period would be one full calendar year effective in 2017 and beyond. CMS is providing a limited exception under the Medicaid EHR Incentive Program for providers demonstrating meaningful use for the first time who would be eligible to report for a 90-day continuous period. ASNC opposes a full-year reporting period effective in 2017 and recommends retaining a 90-day continuous reporting period in 2017 and through the initial years of Stage 3. A full-year reporting period unfairly punishes EPs who attempt to meet meaningful use requirements but are unsuccessful. Full-year reporting does not allow sufficient time for these practices to identify shortcomings in their adherence to meaningful use and implement corrective actions before the next reporting period. Additionally, software updates, switching EHRs and other real-life situations that result in system downtime must be allowed for and is not possible with a full-year reporting requirement. Criteria for Stage 3 Meaningful Use Objective Three Clinical Decision Support Measure 1: The EP must implement five clinical decision support interventions related to four or more Clinical Quality Measures (CQMs) at a relevant point in patient care for the entire EHR reporting period. Absent four CQMs related to an EPs scope of practice or patient population, the clinical decision support interventions must be related to high-priority health conditions. Measure 2: The EP has enabled and implemented the functionality for drug-drug and drug-allergy interaction checks for the entire EHR reporting period. ASNC Recommendation: ASNC recommends that Measure 1 be modified to allow an EP to implement five clinical decision support interventions related to four more CQMs or related to high-priority health conditions. Increasingly, physicians are participating in clinical data registries as a

3 tool for improving quality. This year, ASNC launched ImageGuide Registry, the first registry ever developed for non-invasive cardiac imaging, which will collect data that will lead to improvements in patient quality and safety, as well as test appropriateness. Because the metrics collected through ImageGuide will be specific to the practice of nuclear cardiology, ASNC members would benefit from implementing clinical decision support interventions consistent with ImageGuide metrics rather than those associated with CQMs which are non-specific to the practice of nuclear cardiology. Objective Four Computerized Provider Order Entry (CPOE) Measure 1: More than 80 percent of medication orders created by the EP during the EHR reporting period are recorded using CPOE. Measure 2: More than 60 percent of laboratory orders created by the EP during the EHR reporting period are recorded using CPOE. Measure 3: More than 60 percent of diagnostic imaging orders created by the EP during the EHR reporting period are recorded using CPOE. ASNC Recommendation: For Stage 3, we ask CMS to consider whether the CPOE is topped out by CMS standards and should be removed from the program. In the proposed rule, CMS states that for Stage 1, the median performance for medication orders was 95 percent, and the median performance for laboratory orders was 80 percent for Stage 2. At a minimum, we ask CMS to take a gradual approach to increasing the CPOE threshold for diagnostic imaging orders. For Stage 2, the measure threshold for laboratory orders was 30 percent. Should CMS decide to retain the CPOE objective for Stage 3, we ask for the initial threshold for Measure 3 to be set at 30 percent. Objective 5: Patient Electronic Access to Health Information (EP must meet both measures) Measure 1: For more than 80 percent of all unique patients seen by the EP: Option 1: The patient (or patient-authorized representative) is provided access to view online, download, and transmit their health information within 24 hours of its availability to the provider; or Option 2: The patient (or patient-authorized representative) is provided access to an ONC-certified Application Program Interface (API) that can be used by third-party applications or devices to provide patients (or patient-authorized representatives) access to their health information, within 24 hours of its availability to the provider.

4 Measure 2: The EP must use clinically relevant information from CEHRT to identify patientspecific educational resources and provide electronic access to those materials to more than 35 percent of unique patients seen by the EP during the EHR reporting period. ASNC Recommendation: For Measure 1, CMS is seeking comment on whether to mandate both options which would require providers to offer the view, download and transmit function, as well as access to an API. We support the flexibility of EPs to choose whether to provide patient access to an ONC-certified API rather than making it a requirement. ASNC opposes the proposed requirement under Measure 1 that an EP must provide the patient (or patient-authorized representative) access to view online, download, and transmit their health information within 24 hours of its availability to the provider. The proposed timeframe is unreasonable and could disrupt, rather than improve, patient-provider communications. A primary function of nuclear cardiologists is to conduct nuclear studies, a vast majority of which are performed on patients with complex cardiovascular disease. We urge CMS to maintain the current Stage 2 requirement of four days to make health information accessible after it becomes available to the EP. We also ask CMS to define the term availability to the provider. Specifically, does available mean after test results are interpreted and annotated? ASNC believes it is important that physicians have as much flexibility as possible to provide health information resources in a format chosen by the patient. To preserve this flexibility, we urge CMS to maintain for Measure 2 a threshold of 10 percent as established for Stage 2. Because patient-specific educational resources must be identified using clinically relevant information from the EHR, the result may be educational material based on what is in the problem list or medication list, for example, rather than more clinically relevant information. Consequently, physicians may be forced to provide patients with more information than what is necessary or important. For these reasons, the measure threshold should remain at 10 percent for Stage 3. Objective 6: Coordination of Care through Patient Engagement Objectives (The EP must attest to the numerator and denominator for all three measures but are only required to meet the threshold for two of the three measures.) Measure 1: During the EHR reporting period, more than 25 percent of all unique patients seen by the EP actively engage with the EHR made accessible by the provider. An EP may meet the measure by either: Option 1: More than 25 percent of all unique patients (or patient-authorized representatives) seen by the EP during the EHR reporting period view, download or transmit to a third party their health information; or Option 2: More than 25 percent of all unique patients (or patient-authorized representatives) seen by the EP during the EHR reporting period access their health information through the use of an ONC-certified API that can be used by third-party applications or devices.

5 Measure 2: For more than 35 percent of all unique patients seen by the EP, a secure message was sent using the electronic messaging function of CEHRT to the patient (or the patient's authorized representatives), or in response to a secure message sent by the patient (or the patient's authorized representative). Measure 3: Patient-generated health data or data from a non-clinical setting is incorporated into the certified EHR technology for more than 15 percent of all unique patients seen by the EP. ASNC Recommendation: Because EPs have expressed difficulty in meeting the patient engagement objective for meaningful use, CMS is proposing to remove the 5 percent threshold for Measure 2 from the EP Stage 2 Patient Electronic Access objective for and instead require that at least one patient seen by the provider during the EHR reporting period views, downloads or transmits his or her health information to a third party. We believe this is an appropriate response by CMS. Physicians are growing increasingly frustrated with being held accountable for measures for which they lack control. ASNC recommends the threshold for Measure 1 should be at least one patient, consistent with CMS proposed modification for At a minimum, the measure threshold should not be increased to 25 percent and instead should be lowered to the original Stage 2 threshold of 5 percent as physicians continue to educate their patients about accessing their information electronically and as new systems, such as APIs, make it less burdensome for physicians to provide and for patients to access information electronically. Also, consistent with our comments for Objective 5, we support the flexibility of EPs to choose whether to provide patient access to an ONC-certified API rather than making it a requirement. We appreciate CMS has changed the Measure 2 for Stage 3 so that it is in the control of the provider rather than the patient. However, we do not support Measure 2 as proposed. First, we believe physicians should communicate via secure electronic message with their patients only when it is necessary, not to achieve a measure threshold. Second, we do not agree with CMS that a physician should be required to respond electronically to patient messages. Measure 2 could be simplified further by defining communicate as when a provider sends a message to a patient (or the patient s authorized representative) or when the patient (or the patient s authorized representatives) sends a message to the provider. We also urge CMS to maintain the measure threshold at the Stage 2 level of 5 percent to avoid unnecessary communications to meet a measure threshold. Given the lack of control EPs have over patient engagement measures and because EPs are at risk of reimbursement reductions if patient engagements fail to meet a threshold, we strongly oppose the addition of Measure 3 regardless of the flexibility that CMS has proposed for EPs to meet measure thresholds for only 2 of 3 measures. Objective 7: Health Information Exchange (HIE) (The EP must attest to the numerator and denominator for all three measures but only required to meet the threshold for two of the three measures.)

6 Measure 1: For more than 50 percent of transitions of care and referrals, the EP that transitions or refers their patient to another setting of care or provider of care: (1) creates a summary of care record using CEHRT; and (2) electronically exchanges the summary of care record. Measure 2: For more than 40 percent of transitions or referrals received and patient encounters in which the provider has never before encountered the patient, the EP incorporates into the patient's EHR an electronic summary of care document from a source other than the provider's EHR system. Measure 3: For more than 80 percent of transitions or referrals received and patient encounters in which the provider has never before encountered the patient, the EP performs clinical information reconciliation. The provider would perform reconciliations for the following three clinical information sets: Medication. Review of the patient's medication, including the name, dosage, frequency, and route of each medication. Medication allergy. Review of the patient's known allergic medications. Current Problem list. Review of the patient's current and active diagnoses. ASNC Recommendation: Because HIT interoperability is still lacking, we support that CMS is proposing for Measures 1 and 2 to allow a provider to use a wide range of HIT exchange to receive or send an electronic summary of care document, even though the certified EHR technology must be used to create the summary of care document. However, because the infrastructure for HIT exchange is still being developed, we urge CMS to lower the thresholds for Measures 1 and 2 for the initial years of Stage 3. For Measure 1, we support CMS proposal to allow the provider to use his/her judgment when deciding which items historically present on the problem list, medical history list, or surgical history list are relevant given the clinical circumstances and should therefore be included in the summary of care document. We also support CMS proposal to allow providers the discretion to define the relevant clinical notes or relevant laboratory results to send as part of the summary of care record. For Measure 2, we appreciate that CMS is proposing to accommodate situations when the summary of care is unavailable and therefore can be excluded from the measure denominator. However, when determining which transitions or referrals should be excluded from the denominator, we suggest it may be difficult to track and measure whether a summary of care document was requested and whether a summary was received in direct reply to that specific request. We expect it may also be difficult to track and measure whether a valid query was sent and whether data specific to the query was or was not returned. Because this measure would be newly added to the meaningful use program, we recommend the measure threshold be lowered significantly than the proposed 40 percent for the initial years of Stage 3. Objective Eight Public Health and Clinical Data Registry Reporting

7 CMS proposes to consolidate all optional public health agency (PHA) and clinical data registry (CDR) objectives into one new mandatory objective to require EPs to report on two, in any combination, of five available measures: 1) immunization registry reporting; 2) syndromic surveillance reporting; 3) case reporting; 4) public health registry reporting; and CDR reporting. As previously mentioned, ASNC is home to ImageGuide, which has been recognized by CMS as a Qualified Clinical Data Registry (QCDR) for We are pleased that CMS is recognizing the value of CDRs and has made CDR reporting a measure option for EPs under this objective. For many specialties, including nuclear cardiology, the other PHA measures are not relevant. However, mandating this objective, particularly for specialty physicians who will largely rely on CDRs to meet the objective, is premature. We do not believe timeframes being proposed by CMS for meeting this objective will provide sufficient time for EHR vendors to develop the capabilities to connect to CDRs for the submission of quality data. Furthermore, we oppose adding data reporting requirements to EPs until CMS recognizes CDR reporting for fulfilling the CQM reporting for meaningful use. In fact, to reduce reporting burden on physicians and to make sure that capture of clinical quality data is meaningful to the physician, we urge CMS to deem an EP who is participating in CDR/QCDR activity as satisfying meaningful use. Additionally, if an EP meets the exclusions for Measures 1-4, the EP should not be required to participate in two CDRs. This could impose significant cost and administrative burden to a practice and could require a practice s EHR to have the capability to submit data, on different measures, to two separate registries. Should CMS decide to finalize the Objective 8 measure for Stage 3, at a minimum, we strongly encourage CMS only require EPs to report on one of the five measures and to maintain the proposed exclusions.