CMS-3310-P & CMS-3311-FC,

Transcription

1 Andrew M. Slavitt Acting Administrator Centers for Medicare & Medicaid Services Hubert H. Humphrey Building 200 Independence Ave., S.W., Room 445-G Washington, DC Re: CMS-3310-P & CMS-3311-FC, Medicare and Medicaid Programs; Electronic Health Record Incentive Program Stage 3 and Modifications to Meaningful Use in 2015 through 2017 Final Rule with Comment Period Dear Mr. Slavitt: On behalf of our over 140 member hospitals and integrated health systems located in Wisconsin and employing the great majority of Wisconsin physicians, the Wisconsin Hospital Association (WHA) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Medicare and Medicaid EHR Incentive Programs final rule with comment period. Our comments will focus on the areas identified in the final rule as open to comment, i.e., the final policies for the Stage 3 objectives and measures and the EHR reporting period for Stage 3 in 2017 and subsequent years. WHA recommends revisions to the Stage 3 requirements that will better align Stage 3 with prior experience, better ensure that reporting requirements are supported by mature certification standards, and provide greater flexibility for reporting on meaningful use measures. While CMS s finalized requirements for Stage 3 offer promising ideas, there is insufficient experience of successful provider performance at Stage 2 to be confident that these requirements for Stage 3 are feasible and appropriate. The transition to new technology supporting Stage 2 has been a challenge for providers due to lack of vendor readiness, mandates to use untested standards, compressed timelines, and enormous expenses. WHA is also concerned that specific reporting measures are unnecessarily difficult to achieve without significant expense or disruption to patient care workflow. In addition, the standards needed to support many of the Stage 3 requirements, such as incorporation of patient-generated data and use of application-programming interfaces to enable patients to access health information using third-party applications, are not yet mature enough to be included in regulation. Our detailed comments (attached) elaborate on our recommendations. Under the Medicare Access & CHIP Reauthorization Act (MACRA), Medicare penalties for physicians will cease to be assessed through the EHR Incentive Program and will instead be assessed through the Merit-Based Incentive Payment System (MIPS) beginning in In the EHR Incentive Program final

2 Page 2 of 9 rule with comment period, CMS says that it may consider submitted comments as it plan[s] for the incorporation of meaningful use into MIPS. We encourage CMS to consider this comment letter as it writes rules for the MIPS meaningful use requirements for physicians, and we likewise encourage CMS to consider the EHR-related portions of the letter that we submitted to CMS on November 17, 2015, that commented on a request for information on implementation of MACRA. Wisconsin hospitals and health systems have been leaders in making health information technology (HIT) investments to help them deliver higher quality and more cost effective health care, with many of these investments beginning well before the establishment of the EHR Incentive Program. According to the ONC, as of 2014, 78.1 percent of Wisconsin hospitals have adopted certified electronic health record (EHR) technology, a rate nearly 20 percent higher than the national average. And according to this spring s release of the Agency for Healthcare Research & Quality s quality measure scores, Wisconsin received the second-highest score in the country and received exceptionally high scores for the quality measures related to the adoption of EHR technology. Ultimately, Wisconsin hospitals and health care systems have made their investments in EHR technology and other HIT as a means to enable their provision of higher quality and lower cost health care to citizens in Wisconsin. WHA is concerned, however, that parts of the regulatory framework in Stage 3 of the EHR Incentive Program will require investments and workflow disruptions that will outweigh potential health care cost savings or improvements in outcomes. In order to better ensure that the benefits of meaningful use requirements outweigh the costs of the regulation, WHA believes that future program requirements should be based on lessons learned from the challenges that providers are facing in trying to meet current program requirements. Unfortunately, certain provisions of the final rule for Stage 3 are based neither on experiences gained from Stage 2 nor a realistic assessment of the readiness of certain health IT standards. WHA believes that by critically assessing what is working and what is not working with Stage 2 and applying this experience to the Stage 3 regulations, health care providers and patients can be better assured that the investments made and costs to meet the Stage 3 requirements will yield a return on investment in the form of higher quality and more cost-efficient health care. Thank you again for the opportunity to comment. If you have any questions, please contact Andrew Brenton at (608) or abrenton@wha.org. Sincerely, Eric Borgerding President Attachment

3 Page 3 of 9 I. Revisions to the Stage 3 requirements that will better align Stage 3 with prior experience a. Postpone the required start of Stage 3 until a date no sooner than 2019 WHA recommends that CMS postpone the required start of Stage 3 until at least the start of MIPS in WHA further recommends that providers not be required to begin Stage 3 until at least 75 percent of hospitals and 75 percent of physicians have met Stage 2. The majority of hospitals (EHs/CAHs) and physicians (EPs) have not successfully demonstrated Stage 2. According to CMS, only 38 percent of participating hospitals and 11 percent of participating physicians met Stage 2 in Even in Wisconsin, where our hospitals began to adopt and use EHR technology before the EHR Incentive Program began, Stage 2 has not yet had enough widespread successful demonstration to have yielded experience that can be used to erect workable, feasible Stage 3 reporting standards. There is a lack of experience from Stage 2 to establish experience-based Stage 3 standards that advance the goal of the meaningful use program to deliver high-quality, patient-centered, and cost-efficient health care. In addition, the EHR development and certification cycle to date has required a minimum of 18 months from the time of the release of new meaningful use rules to the start of the new stage, as recommended by the Health IT Standards Committee. Once hospitals receive the updated EHR software, the experience to date indicates that up to an additional 19 months is required to implement the new technology safely and successfully. This process includes time for software assessment, installation, implementation, staff training, time to build up to the performance metrics required by meaningful use, and time to capture actual data in a reporting period. It is unlikely that all providers will have fully implemented 2015 Edition certified EHR technology and be ready to begin a full-year reporting period starting on January 1, Rather, it is more likely that the past experience vendor delays and the prospect of penalties for providers, despite their best efforts at complying with the regulatory requirements will be repeated. b. Establish a 90-day EHR reporting period for the first year of any new stage WHA recommends that a 90-day EHR reporting period be available for the first year of Stage 3 and any subsequent stages, as well as whenever there are changes to the definition of certified EHR technology, including a new edition of technology or new functionality. We believe that a full year of reporting for the first year of Stage 3 is unrealistic. The first year of Stage 1 and Stage 2 offered a 90- day EHR reporting period, which proved to be essential to supporting a safe and orderly transition to use of new technology. In addition, new entrants to the program should continue to have a 90-day EHR reporting period in their first year of participation, because providers new to the program need time to install and learn to use technology before reporting. c. Eliminate the all or nothing approach in meaningful use WHA recommends that successful demonstration of meaningful use not be predicated on full achievement of every reporting requirement. This all-or-nothing approach, which subjects providers to significant Medicare reimbursement penalties for failing to meet a single measure by even a single percentage point, is punitive. Nor does it accomplish Congress s goal of widespread hospital (EH/CAH) and physician (EP) adoption and use of EHRs in way that improves health care quality and positively

4 Page 4 of 9 impacts patient care, because the provider that meets all but one reporting measure would be subject to the same reimbursement penalties as the provider that has not met any measure. d. Provide an attestation period of sufficient length to accommodate all providers that will attest simultaneously WHA recommends that CMS finalize a data submission period of 120 days rather than the current 60-day submission period. Aligning the reporting period for hospitals (EHs/CAHs) and physicians (EPs) to a calendar year also aligns the data collection and reporting period for meaningful use and for CMS clinical quality measure reporting. An aligned 60-day submission period, however, will likely present submission issues for program participants and for CMS. Experience to date with the separate data submission period for hospitals and physicians indicates that both hospitals and physicians are challenged to submit their data due to capacity issues with CMS s attestation system. Indeed, CMS has extended on multiple occasions the attestation period beyond 60 days to accommodate the volume of reports being submitted. e. Postpone mandatory electronic reporting of electronic clinical quality measures WHA recommends that CMS not require electronic submission of clinical quality measures (CQMs) for a full year in WHA strongly supports the long-term goal of using EHRs to streamline and reduce the burden of quality reporting while increasing access to real-time information to improve care. But the majority of hospitals (EHs/CAHs) and physicians (EPs) have not electronically submitted CQMs and additional work is necessary to improve the feasibility, reliability, and accuracy of electronic reporting. Therefore, required electronic submission of CQMs for a full year in 2018 is an unrealistic goal. ecqms must be valid, reliable, and feasible to report, and experience to date indicates that ecqms have required hospitals to expend considerable effort to modify how data are captured and the locations in the EHR where data are captured, but have not yet resulted in measurement data that are comparable across measurement methodologies. II. Revisions to the Stage 3 requirements that will better ensure that reporting requirements are supported by mature certification standards WHA recommends that CMS refrain from including requirements in regulation that providers use a standard or functionality in certified EHRs in advance of evidence that the standard or functionality is ready for nationwide use. WHA also recommends that robust testing and implementation guidance of mature standards must precede requirements for provider use. The transition to new technology supporting Stage 2 has been a challenge for providers due to lack of vendor readiness, mandates to use untested standards, compressed timelines, and enormous expenses, and CMS should apply this experience to Stage 3. For example, it is premature to require that providers use application-programming interfaces (APIs) in the EHR to make health information accessible by any application that requests to access to the information. Although ONC finalized three certification criteria in support of APIs in the 2015 Edition Certification Rule, it specifically did not recognize a standard for APIs, citing standards immaturity. Additionally, ONC finalized the API requirements without specifying

5 Page 5 of 9 a certification approach or framework applicable to the applications that would extract data from the EHR. Requirements to use new functionality such as APIs must be accompanied by standards that are mature, rigorously tested, and accompanied by implementation guidance that minimizes variation in the interpretation of the standard. Providers should not be required to use APIs or to share protected health information with applications where the APIs or applications have not been certified by ONC. III. Revisions to the Stage 3 requirements that will provide greater flexibility for reporting on meaningful use measures WHA supports a meaningful use program that introduces new reporting items as menu or optional in any new stage. This approach has three discrete benefits: it allows some hospitals (EHs/CAHs) and physicians (EPs) to report on new measures, it allows CMS to collect data and gather experience before prematurely imposing developing standards on all providers, and it does not penalize providers for not reporting on standards that do not have widespread acceptance or are premature. Continuing this approach in Stage 3 would be all the more appropriate considering that some of the finalized requirements are new or too premature to be required for all providers. In this context, WHA does not support these CMS requirements for Stage 3 that introduce reporting requirements for providers that are new to Stage 3: The requirement for Stage 3 hospitals to send a secure electronic message to 25 percent of patients (since in Stage 2 secure electronic messaging is not a measure for hospitals); The requirement for Stage 3 providers to incorporate into the EHR patient-generated health data or non-clinical health data for 5 percent of patients; and The requirement for Stage 3 providers to incorporate into its EHR, for 40 percent of new-patient transitions or referrals, electronic summary of care documents received from a source other than the provider s own EHR; and The requirement for Stage 3 providers to perform clinical information reconciliations of medication allergy and current problem list for 80 percent of new-patient transitions or referrals. In addition, WHA strongly feels that if a Stage 2 menu or optional reporting item is being retained in Stage 3 as a required item, CMS should retain the existing performance threshold for Stage 3. We provide specific comments below on the finalized changes to certain objectives and associated measures. In several places, we note that CMS is putting the ability of providers to succeed largely outside of providers control by making success contingent on the actions of others. We believe that this is unfair and make recommendations that hold providers accountable only for those things that they can control, such as having appropriate EHR technology in place. a. Objective 2: electronic prescribing WHA opposes the requirement to increase the electronic prescribing thresholds for hospitals from 10 percent to 25 percent. We recommend that hospitals be required to attest only that they are using electronic prescribing at discharge. Electronic prescribing of discharge prescriptions by hospitals (EHs/CAHs) is an optional, menu objective in Stage 2 with a measure threshold of 10 percent. WHA

6 Page 6 of 9 has long recommended that when an item moves from being optional to being required it should retain the same threshold, because optional items will have limited actual use by providers, and experience in the clinical environment should precede an increase in provider requirements for performance. Implementing electronic prescribing in the hospital environment is complicated and will require significant workflow changes and costs. b. Objective 3: CDS For the first measure, WHA recommends removing the tie between CDS and CQMs in favor of allowing hospitals to use CDS to meet their high-priority safety and quality improvement objectives. The first measure requires five CDS interventions related to five or more CQMs at a relevant point in patient care for the entire EHR reporting period. WHA s recommendation to remove the tie between CDS and CQMs would better allow hospitals to use EHR technology to meet quality improvement goals while removing the measurement burden of tracking the links between CDS and CQMs; it would give hospitals (EHs/CAHs) the flexibility to start and stop their use of specific CDS tools in accordance with their unique quality improvement activities. For the second measure, WHA recommends removing the entire EHR reporting period language from the measure specification to limit unnecessary measurement burden. For the second measure, CMS requires providers to enable and implement the functionality for drug-drug and drug-allergy interaction checks for the entire EHR reporting period. WHA believes that its recommendation to remove the entire EHR reporting period from the measure specification would not be inconsistent with the purposes of the EHR Incentive Program but would limit unnecessary measurement burden for providers. c. Do not require use of API functionality While WHA supports the concept of using APIs to share data, we believe that it is premature to require their use by providers in the meaningful use program because of the lack of standards maturity and potential security risks. Although CMS requires the use of APIs in support of Objectives 5 and 6, the standards for APIs are currently premature (as explained in greater detail above), and there is no evidence as to their readiness for a clinical setting. In addition, new technology approaches that engage third parties in the exchange of data between patients and providers must be supported within the context of the existing HIPAA framework: third parties, including developers of applications that receive, aggregate, and transmit data must be covered by the same HIPAA requirements as other business associates of providers. Finally, WHA has significant concerns that the introduction of APIs could introduce security risks to providers health information systems. Hospitals are part of the nation s critical infrastructure and are responsible for keeping systems as secure as possible. Accordingly, they must proceed carefully when introducing new technologies that touch their system. d. Objective 5: patient electronic access to health information For the second measure, WHA opposes the increase in the performance threshold to 35 percent and urges CMS to allow providers to include in the numerator non-electronic mechanisms for enabling patients to access educational resources. For the second measure, CMS increases the threshold for

7 Page 7 of 9 electronic provision of patient-specific educational resources from 10 percent in Stage 2 to 35 percent in Stage 3 and disallows providers from counting paper-based resources in the numerator. WHA believes that the threshold presents a very high bar and is not supported by any evidence that this is the optimal level to achieve better health outcomes. Additionally, WHA believes that successful patient engagement must use a full array of mechanisms that support patient preference in the manner of engagement whether in-person, electronically, or through paper-based materials. Providers should not be penalized for respecting patient preferences to receive educational resources through means other than accessing the EHR. e. Objective 6: coordination of care through patient engagement For the first measure, WHA recommends that CMS require Stage 3 providers only to ensure that they have the functionality to allow patients to engage with or access their health information using the patient portal or an API-enabled third-party application. WHA strongly supports patient engagement and thinks that our recommendation represents a more realistic and fairer approach. For Stage 3, CMS requires providers to use certified EHR technology to engage with patients or their authorized representatives in the coordination of care. The first of the three measures requires more than 10 percent of patients to access their health information using the patient portal or a third-party application linked with the EHR through an API. This threshold seems arbitrarily high and not based on actual performance in Stage 2. In 2014, providers cited the engagement of patients with the patient portal as one of the most difficult of the Stage 2 criteria to meet, and CMS data on the performance of providers on this measure for Stage 2 underscored this point. As patients should have the ability to exercise their preferred method of engagement, we believe that it is unfair to hold providers accountable if patients select a means of engaging their provider other than through the use of the EHR portal or third-party applications linked to the EHR. Consistent with the philosophy behind Stage 2, WHA believes that the second measure should not be applicable to hospitals because a patient following an acute care visit is more likely to access information through a primary care provider than from the hospital directly. For the second patient engagement measure, CMS requires that for more than 25 percent of patients, the EHR be used to send a secure message to the patient or used in response to a secure message sent by the patient. Apart from the general inappropriateness of this measure for hospitals, WHA believes that the performance threshold is arbitrarily high and not based on actual performance in Stage 2. We believe that it is appropriate to measure the provider s use of the secure message but not the patient s responsiveness or utilization of this technology; patients should be able to choose the mechanism supporting their engagement with their provider. For the third measure, WHA is concerned about the readiness of data validation standards and standards surrounding the ability to match the data to the correct patient record, and recommends that CMS eliminate this requirement. The third measure requires providers to incorporate into the EHR patient-generated health data or non-clinical health data for more than 5 percent of patients. WHA believes that the standards needed to support this measure are not yet mature enough to be included in regulation. It is also unclear whether the benefits of incorporating such data will outweigh the implementation and

8 Page 8 of 9 ongoing operational costs: even if the technology were mature enough to support this measure, it is unclear whether 5 percent of all patients will benefit from having patient-generated data entered in the EHR. WHA also believes that this proposal creates unique medical-legal issues that need to be considered and addressed before the start of Stage 3. f. Objective 7: health information exchange WHA believes that the performance thresholds are too high and not experience-based and that CMS should closely reevaluate the clinical exchange requirements, standards, and environment before requiring a higher threshold than providers have hitherto been able to meet. For the first measure, WHA is concerned that the 50 percent performance threshold is unrealistically high and that electronic exchange of summary of care records warrants further consideration by CMS. For this measure, CMS requires providers to create and send electronically a summary of care document for more than 50 percent of transitions of care and referrals, which represents a very significant increase from the 10 percent required for electronic exchange in Stage 2. WHA believes that the 50 percent performance threshold is unrealistic and infeasible. As an illustration, CMS reported that in 2014 the lowest quartile of hospitals reached a 19 percent threshold and the highest quartile reached 48 percent. WHA recommends that CMS closely reevaluate the clinical exchange requirements, standards, and environment before requiring a higher threshold than providers have hitherto been able to meet. WHA is concerned that the second measure is not clinically based and will make it difficult for providers successfully to demonstrate meaningful use. For this measure, CMS requires that providers incorporate into their EHR systems 40 percent of new-patient electronic summary of care records received from a source other than the provider s own EHR system. This measure is new, and the rather high performance threshold appears to be arbitrary and not based in clinical experience. A survey of WHA member hospitals shows that the great majority of respondents are either very concerned or concerned with this proposed measure with 36 percent of all respondents being very concerned. WHA believes that performing reconciliation for medication allergy and current problem list should be optional reporting items because they are being introduced into the meaningful use program for the first time in Stage 3. For the third measure, CMS requires that providers perform a clinical information reconciliation for medication, medication allergy, and current problem list, for more than 80 percent of new-patient transitions of care and referrals. WHA s specific recommendation for this measure is consistent with our general recommendation that new reporting items should be introduced as menu or optional in any new stage. g. Objective 8: public health & clinical data registry reporting WHA recommends that CMS retain the modified Stage 2 requirements for this objective. We also recommend that CMS continue efforts to support public health agencies in their ability to receive data in accordance with this reporting requirement. CMS should continue to provide alternate exclusions to the measures in the public health reporting objective until CMS has launched a database of available registries

9 Page 9 of 9 to facilitate measure reporting. Registries that receive data from certified EHRs should be subject to certification to ensure that they are capable of receiving data in the required formats.