Detailed Analysis of the Final Rules on Stage 2 of Meaningful Use

Transcription

1 Health Care IT Suite Detailed Analysis of the Final Rules on Stage 2 of Meaningful Use The Journey Continues September 2012 Robin Raiford Research Director Anantachai (Tony) Panjamapirom Consultant Ernie Hood Senior Research Director Shakira Pollard Senior Analyst 2445 M Street NW Washington DC P F advisory.com September 4,

2 2

3 3 Table of Contents Overview of the Stage 2 Final Rules... 4 Key Changes from the Proposed to Final Rules... 6 Stage 2 Timing and Program Staging... 7 Certified EHR Technology Updates Edition Certified EHR Technology... 9 New Terms and New Flexibility Changes and Additions of Required Standards Substantial Revised and New Certification Criteria for EHRs Core and Menu Set Requirements Clinical Quality Measures Changes to CQM Requirements New and Revised to CQM Data Capture and Export Requirements Alignment with Other Reporting Initiatives Reporting Options Medicare Payment Adjustments Eligible Hospitals Eligible Professionals Changes to the Medicaid EHR Incentive Program Appeals and Audit Appeals Audits Acronym Key Appendix A: Stage 1 to Stage 2 Quick Guide Comparison Appendix B: Changes to Stage 1 Measures Appendix C: Comparison of Stage 2 NPRM to Final Rule Measures Appendix D: Required Data Elements for EHs/CAHs and EPs to Meet View, Download, and Transmit Measures Appendix E: Required Data Elements for EHR Vendors to Comply with Data Portability Certification Appendix F: Crosswalk of Standards CMS and ONC Final Rules September 4, Appendix G: EHR Certification Modules for 2014 Edition... 56

4 4 Overview of the Stage 2 Final Rules On August 23, 2012, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator (ONC) released the next round of rule making in the journey to meaningful use (MU) to the Federal Register Inspection Desk. The official posting of these final rules will appear in the Federal Register on September 4, The CMS Electronic Health Record (EHR) Incentive Program and the ONC 2014 Edition final rules reinforce the government s unwavering commitment to ensure widespread adoption of Certified EHR Technology (CEHRT). These final rules will advance the next set of certification, standards, and MU criteria that eligible hospitals (EHs), critical access hospitals (CAHs), and eligible providers (EPs) must demonstrate to continue to successfully achieve meaningful use. The next phase of core and menu set measures are, on the whole, more aggressive than those of Stage 1. With Stage 1 focused on the adoption and implementation of CEHRT and the capture of critical, structured data elements, CMS intends for Stage 2 to advance clinical processes for continuous quality improvement, and to pave the way for Stage 3 to advance quality outcomes. The overall number of objectives does not increase, and CMS has retained its basic framework of a core and menu set of objectives with corresponding measures required. CMS has eliminated some Stage 1 measures, modified others, and added entirely new measures to achieve its goals. These new measures will serve as the impetus for providers to advance along the following vectors: Information Exchange: In Stage 1, CMS required little more than a test of information exchange capabilities. In Stage 2, providers will move beyond a test to widespread use through a more robust summary of care record measure, where CMS requires that providers transmit the summary of care record electronically in 10% of instances in addition to providing that summary of care record via an unspecified means for 50% of transitions of care and referrals. The one-test requirement demonstrating a single proof-of-concept also disappears from all population and public health objectives in Stage 2, and is replaced by the requirement for ongoing submission, regardless of whether the data is part of the core or menu set. Patient Engagement: CMS is eliminating the requirement to provide patients with an electronic copy of their health information in favor of an objective similar to the Stage 1 EP requirement to provide patients with electronic access. In Stage 2, EPs and EHs alike will be required to support an infrastructure that allows patients to view, download, and transmit their health information. Even more striking, CMS will require patients to engage in their healthcare by viewing, downloading, or transmitting their information in 5% of instances (this outcomes measure will accompany a process measure that requires the hospital to provide such access to over 50% of patients). High-Quality, Real-Time Data Capture: While many structured data elements were captured in Stage 1 (e.g., problems, medications, and medication allergies), they were not widely leveraged for clinical process and outcome improvement. For example, in Stage 1, providers were able to meet the measure of meaningful use by capturing one problem in a problem list, without meeting the intent of the requirement to maintain an up-to-date problem list. In addition, by shifting the paradigm on patient

5 5 health information from providing a copy upon request to providing a majority of patients with on-demand real-time access, CMS now sets the stage for data to be put to productive use. Workflow changes will be necessary to accommodate such continuous use of the ever-ready data, which particularly mandates 36 hours for EHs/CAHs and four days for EPs. This will force providers to better manage the timeliness of capturing this data electronically in the CEHRT to ensure accuracy and completeness and support continuous viewing and use by patients and clinicians In addition to bringing forth new as well as enhanced core and menu set objectives, CMS has used the final rule to adjust and clarify the program. The following topics are discussed in further depth in this report: Key changes from the proposed to final rules Stage 2 timing and program staging Certified EHR Technology updates Core and menu set requirements Clinical quality measures Medicare payment adjustments Changes to the Medicaid EHR Incentive Program Appeals and audit In parallel to the CMS final rule defining meaningful use for 2014 and beyond, ONC has issued a final rule on standards, implementation specifications, and certification criteria for EHR technology to support the next round of meaningful use. The rule, referred to as the 2014 Edition, represents an entirely new definition for CEHRT. The new definition of CEHRT will allow providers more flexibility in terms of which modules of a CEHRT must be in live production to achieve meaningful use. Eliminated is the need to possess EHR modules that are not going to be used to achieve meaningful use until a future stage. The term CEHRT will now have a more dynamic definition related to needing only certified EHR modules that support demonstrating meaningful use, including the core and selected menu set measures for the individual stage and any given year. Lastly, ONC has made significant revisions and additions to the certification criteria for EHRs. To support advanced clinical processes through information exchange and care coordination among multiple providers across the continuum of care, ONC has worked in congruence with CMS to require EHRs to incorporate structured data received from another source with existing information maintained by the EHRs. Such requirements can subsequently facilitate meaningful use and interoperability of the combined, structured data, which is the ultimate goal in Stage 3. ONC has also finalized two additional certification criteria that focus on driving innovation and transparency among EHR vendors. First, an EHR technology must have Data Portability capability, which allows providers to easily migrate structured data from one EHR to another foreign EHR. Second, ONC requires EHR vendors to use Quality Management Systems (QMS) to improve transparency of their software development process. These additions in the 2014 Edition will serve as a foundation for further development of more robust EHR systems.

6 6 Key Changes from the Proposed to Final Rules Relief on timing adjustments and upgrades. CMS is relaxing the timing of the stages and upgrade schedule. For those providers that started the EHR Incentive program in 2011, a third year on Stage 1 criteria is now allowed, making it possible to stay at Stage 1 through All providers participating in 2014, regardless of stage, will have a one-time, shortened three-month reporting period to allow time to upgrade to 2014 CEHRT. Stage 2 measures increase significantly in complexity but not in number. While a number of Stage 1 measures no longer exist as independent measures, these concepts are subsumed without exception into new, more complex Stage 2 objectives. The total number of objectives EHs/CAHs must meet is 19 (16 core and three menu set objectives). EPs must meet a total of 20 objectives (17 core and three menu set objectives). The final rules hold firm on demanding process and technology requirements for patient engagement and interoperability beginning in Significant changes to Clinical Quality Measures (CQMs) with electronic reporting mandates. Starting in 2014, CQM reporting has been incorporated into the definition of a meaningful user rather than being a core set measure. However, it remains a mandatory requirement for demonstrating meaningful use. The CQM requirements for EHs/CAHs will increase by one to 16 CQMs while the EPs by three to nine CQMs. CMS will mandate electronic submission of CQMs for Year 2 and beyond beginning in Group reporting of CQMs for EPs will be allowed starting in The final list of approved CQMs for 2014 was not included in the final rules, but will be published in the near future by CMS. Electronic notes added as new menu set objective to Stage 2 for EPs and EHs. After receiving support in the public comments about this measure, CMS has added record electronic notes in the menu set in Stage 2. This requires EHs/CAHs and EPs to implement physician documentation modules if this menu set item is selected. This is in sharp contrast to Stage 1 in which many providers relied on nursing documentation to capture the required data elements. Real-time, high-quality data capture is required, but not health information exchange (HIE). CMS has embedded care coordination and information exchange into a number of measures including that 10% of summary of care records be transmitted electronically for transitions of care and referrals. All providers participating in the EHR Incentive Programs can transmit over the Internet via the ONC Direct Project essentially secure or utilize an HIE to meet this measure. This will force providers to move beyond meeting the measure by simply transmitting a single transaction. As patients and clinicians view this information with greater frequency, they will expect accuracy and completeness. Active patient engagement confirmed necessary for achieving meaningful use. The concept of a patient requesting a copy of health information or discharge instructions is eliminated in Stage 2. Instead, providers will need to proactively offer 50% of patients the ability to view, download, or transmit their health information. Additionally, CMS has added a second measure to this objective, mandating that 5% of patients actively engage in the viewing, downloading, or transmitting of their information in order for EHs/CAHs or EPs to satisfy this measure (Year 1 participants do not need to meet the 5% measure).

7 Decreased thresholds ease some of the regulatory burden. The CMS final rule includes some significant reductions in thresholds for compliance. For example, the summary of care document at transition dropped to 50% from 65% (which will be welcomed by the 93% of hospitals that have deferred this measure to date). The eprescribing threshold for EHs in the menu set was reduced to 10% from 50%, and the imaging results threshold is now down 10% from 40%. Additionally, the 5% patient engagement requirement mentioned above is down from 10%. Payment adjustments confirmed to begin in 2015; two-year look-back period applies. Payment adjustments remain intact as they are statutory requirements and cannot be changed by CMS. Providers that do not demonstrate meaningful use in 2013 will be subject to payment reductions in CMS confirmed organizations can start Year 1 in However, first-time attesters in 2014 must complete attestation by July 1, 2014 for EHs, and October 1, 2014 for EPs to avoid a 2015 payment adjustment. In future years, providers must continue to attest to meaningful use s more complex requirements annually to avoid payment adjustments. Medicaid patient volume and population definitions increase provider eligibility. The proposed revisions of Medicaid encounter and patient volume determination are finalized and adopted in the final rule. Beginning with 2013, CMS gives providers greater flexibility in calculating their Medicaid patient volume, which subsequently increases the number of providers that will qualify for Medicaid incentives. Updated Stage 1 objectives for 2013 provide a foundation for Stage 2 readiness. CMS modified some previous Stage 1 requirements. These changes are optional in 2013, but required in Providers selecting the alternative option in 2013 will be one step closer to meeting Stage 2 measures in Stage 2 Timing and Program Staging Related Research Initial Reactions to the Final Rules for Meaningful Use Stage 2 (August 2012) In the Stage 2 final rule, CMS provides significant clarification regarding program staging (e.g., the stage of meaningful use a provider must achieve to qualify for incentives or avoid a payment adjustment in a given year). As illustrated below in Table 3 of the CMS final rule, CMS finalizes that EHs/CAHs and EPs will demonstrate each stage for two years before proceeding to the next stage, regardless of which year the provider initially enters any of the EHR Incentive Programs. In the Stage 1 final rule, CMS defined program staging only through 2014, creating concern that they intended to ramp up to more complex stages quickly in order to start the payment adjustment period in The Stage 2 final rule alleviates that concern. There are differences in timelines for the Medicare and Medicaid EHR Incentive Programs, as well as for Critical Access Hospitals. The timeline differences are: The Medicaid EHR Incentive Program continues through 2021 and allows providers 1 to initiate the program as late as Please note throughout this document where the term providers is used, the situation or reference applies to both EH/CAH and EP

8 The Medicare EHR Incentive Program continues through 2016 and allows providers to initiate the program as late as 2014; however, CAHs can receive EHR incentives only through Table 3 below reflects all program years, regardless of Medicare or Medicaid EHR Incentive Program participation. This table shows the stages required in order to receive an incentive payment and/or not receive the payment adjustment. 8 Table 3: Stage of Meaningful Use Criteria by First Payment Year 2 (Note asterisk 3 indicated in 2014 only) First Payment Year Stage of Meaningful Use * TBD TBD TBD TBD * TBD TBD TBD TBD * TBD TBD TBD * TBD TBD TBD Note that this is a carrots and sticks program with incentives potentially followed by payment adjustments if providers do not continue to demonstrate meaningful use of an EHR. Also notable is that the EHR Incentive Programs may not be limited to three stages. CMS and ONC have been actively discussing in public forums on how to proceed with Stage 4 and beyond enforced by payment adjustments in future cycles of rulemaking. CMS s final rule stipulates, as shown in Table 3, that providers that have successfully attested to meaningful use in 2011 will be allowed to demonstrate a third year at Stage 1 in This change is to accommodate the late release of the final Stage 2 rules. This additional year in Stage 1 will not be afforded to providers that started Year 1 after Centers for Medicare & Medicaid Services, 42 CFR Parts 412, 413, and 495 [CMS-0044-F] RIN AQ84 Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 2 Final Rule, Inspection Document, August 23, 2012, Table 3, Page The asterisk in the table indicated a three-month quarter EHR reporting period for Medicare and continuous 90-day EHR reporting period (or three months at state option) for Medicaid EPs. All providers in their first year in 2014 use any continuous 90-day EHR reporting period.

9 9 Certified EHR Technology Updates The ONC 2014 Edition Final Rule, the companion document of CMS s Stage 2 Final Rule, outlines the new standards and certification criteria to support the CMS EHR Incentive Programs next stage of meaningful use. Specifically, the ONC 2014 Edition Final Rule stipulates the new capabilities that EHs/CAHs and EPs will need to implement as well as standards and implementation guidelines. A new flexibility in utilizing CEHRT is also defined. As previously mentioned, providers will no longer have to possess EHR modules that they do not need to achieve meaningful use for a given year. Starting in 2014, providers will need only to have CEHRT for what they will use to achieve both the core and menu set objectives for which they are attesting in a given year. The major highlights in the ONC Final Rule are: 2014 Edition is mandatory for all participants in All participants, whether new or continuing, in the EHR Incentive Programs will need to have 2014 Edition CEHRT to demonstrate meaningful use for either Stage 1 or Stage 2 in EHs/CAHs will continue to follow a federal fiscal year reporting period, and EPs will follow a calendar year reporting period Edition CEHRT has new, revised, and unchanged certification criteria in comparison to 2011 Edition CEHRT. Approximately 40% of certification criteria remain unchanged in the 2014 Edition. For those EHR certification modules that are unchanged, previously certified EHR modules will be grandfathered in to be 2014 Edition certified. This will ease the burden for EHR vendors and enable them to focus on becoming certified on new and revised criteria for meaningful use in EHs/CAHs and EPs will need to adopt new 2014 Edition CEHRT functionality including using any specified standards and implementation guides identified in the ONC 2014 Edition final rule in order to achieve meaningful use in Revised requirements strengthen interoperability. ONC has made a concerted effort to define a single standard in areas that previously had an either/or standard. For example, the new problem list changes, in the 2014 Edition, to a single standard of Systematized Nomenclature of Medicine (SNOMED), which eliminates the 2011 Edition option of using either International Classification of Diseases, Ninth Revision (ICD-9), or SNOMED Edition Certified EHR Technology The 2011 Edition of CEHRT required participants to have a complete EHR that met all of the possible functionality defined for the core and menu sets of Stage 1 for either hospitals or eligible professionals. This definition also included the requirement to have 100% possession of all EHR modules comprising a complete EHR, including Nfunctionality for menu sets items that were being deferred until Stage 2. A more edynamic definition of 2014 Edition CEHRT offers more flexibility by definition allowing wparticipants to acquire new functionality for their EHRs as needed. This allows having CEHRT in alignment with the participant s target stage of MU and selected menu set measures. Of note, there is no such thing as Stage 1 certified or Stage 2 certified EHRs, since certification criteria in any new edition will cover multiple stages of meaningful use. The correct terms are 2011 Edition certified or 2014 Edition certified. Additionally, the concept for providers applying for self certification of their

10 10 homegrown products and the terms Complete EHR and Modular EHR are unchanged. Timing of upgrade is essential: ONC allows providers to use either 2011 Edition or 2014 Edition CEHRT, or a combination of both Editions for the 2013 reporting period. Starting in 2014, however, all providers attesting to meaningful use are required to use 2014 Edition CEHRT. New Terms and New Flexibility As noted above, and in response to public comment, ONC eliminated the Stage 1 requirement mandating that providers had to possess all modules of a complete certified EHR, including those modules that supported the menu set items that EHs/CAHs or EPs selected to defer until Stage 2. To resolve the issue, ONC created a new framework that measures compliance by considering the functionality of the EHR modules in support of the core items, plus the menu set items selected by each provider (see figure below). In other words, providers will no longer be required to purchase modules they do not need to meet their current stage of meaningful use, based on their menu set selections. Also, it will be easier than in the past for them to be compliant using modules from different vendors. Of note, with the exception of a few features added, the base components are essentially the statutory EHR requirements named in the American Recovery and Reinvestment Act (ARRA) that was referred to as a qualified EHR. * Note that vital signs and view, download, and transmit are finalized as Core capabilities in the 2014 Edition. While this is a welcome enhancement to the process, providers will realize the benefit only if their individual vendors certify their products as EHR modules, in addition to (or opposed to) certifying as a complete EHR. This is because providers are still required to possess all capabilities included in the EHR bundle of products, including all additional software required, that was presented to become a certified Complete EHR. The complete EHR might include a specified bundle of products, which encompass the menu set capabilities that a provider intends to defer. In this case, providers will end up with the functionality they do not need to demonstrate meaningful use in a given year.

11 11 Of note, CQMs were also identified as being required for a qualified EHR. Rather than including CQMs in the base functionality, meeting CQMs now becomes part of the definition of meaningful user and remains a condition for meeting meaningful use. Since CQMs are a statutory requirement, CMS has no authority to remove this functionality from the EHR Incentive Programs, other than to identify applicable exemptions. Changes and Additions of Required Standards ONC has expanded the use of standards in many measures, and has made a concerted move toward a single standard in areas that previously had an either/or standard named in Stage 1. This means that some participants will need to review their processes for capturing those standards. Below are the vocabulary standards for the Summary of Care at transitions and view, download, and transmit. See Appendix D for a complete list of the required data elements required for this measure. A single standard for problem list is now finalized to be SNOMED. Those organizations using the process of having coders select the ICD-9 code that is subsequently interfaced back into the certified EHR to build the problem list will need to evaluate new workflows to accommodate SNOMED in the problem list. Additionally, if clinical staff is entering ICD-9 codes directly into the problem list, organizations will need to develop a new workflow strategy. This new workflow might include the need to have a language engine in place in addition to CEHRT. While numerous standards are embedded into the CEHRT, worth noting are the key standardized vocabularies that will be required for capturing the data elements in the newly defined Meaningful Use Common Data set listed below. This list is significantly more robust than the Stage 1 MU requirement. The Meaningful Use Common Data set standardized vocabulary elements that are required to meet five measures for EHR certification are: Meaningful Use Common Data Set Standardized Vocabulary if required 1. Patient name n/a 2. Sex n/a 3. Date of birth n/a 4. Race 5. Ethnicity 6. Preferred language Office of Management and Budget (OMB) Standard 1997 Office of Management and Budget (OMB) Standard 1997 International Organization for Standardization (ISO) alpha-3 codes limited to those that also have a corresponding alpha-2 code in ISO Smoking status SNOMED CT 8. Problems SNOMED CT 9. Medications RxNorm 10. Medication allergies n/a

12 Laboratory test(s) LOINC 12. Laboratory value(s)/result(s) n/a 13. Vital signs (height, weight, BP, BMI) n/a 14. Care plan field(s) No standard vocabulary but is to include goals and instructions 15. Procedures HCPCS and CPT-4 or ICD-10-PCS 16. Care team members n/a Substantial Revised and New Certification Criteria for EHRs Clinical information reconciliation The beginning of true semantic interoperability will arrive with the 2014 Edition certification requirements. In the 2014 Edition Final Rule, ONC introduces the term "incorporate (not just import) to mean CEHRT must be able to process the structured data contained in three Consolidated Clinical Document Architecture (CCDA) sections (i.e., problems, medications, medication allergies) with existing EHR data. ONC revised this criterion to make this distinction clear. In fact, the more robust standard is required for the view, download, and transmit and the summary of care at transition requirements. It will not be acceptable to simply import these three CCDA sections as a clinical document contained solely under the notes or reference information tab in the EHR. Point being, these sections need to be usable in the EHR, such as used in a logic statement in CDS, and not just contained in a document in the EHR. In the long run, this new functionality will ease clinicians burden of capturing medications, problems, and medication allergies. However, the community of all providers in the EHR incentive program will need to tackle this requirement head on since it is significantly more robust than the Stage 1 requirement (which required only one entry in the problem and medication lists). Providers will now be required to reconcile problem, medications, and medication allergies using CEHRT to meet the care coordination measures. Data portability and quality management reporting introduced into certification of EHRs For the 2014 Edition certification cycle, ONC has adopted two new certification criteria for all Complete EHRs and EHR Modules. The first is Data Portability, which enables a user to electronically create a set of export summaries for all patients in the EHR formatted according to the required standard that represents their most current clinical information. This will allow providers to easily switch EHR technology at a lower cost and migrate most or all of their data in structured form to another EHR technology. Without this capability, providers could be locked-in to their current EHR technology. The data elements to meet the new data portability capabilities are presented in Appendix E. Second, at the recommendation of the Institute of Medicine, ONC has adopted a certification module for QMS. This certification criterion is meant to be a first step that can be built on in an incremental fashion in future certification cycles. This criterion is meant to improve transparency into vendors quality management processes used in software development. For 2014 Edition certification, vendors must identify their use

13 13 of a QMS (or lack thereof) for each module for which they are seeking certification. Any QMS may be used. This will ensure greater visibility into the development process and help create ownership of quality at all levels of the organization. In addition, it should improve the predictability of software version release dates. Note that EHR technology developers are not required to comply with all of the principles of their QMS to be certified, and there is no requirement to become International Standards Organization 9001 certified. Rather, EHR developers must simply document how they do or do not meet the principles and processes specified in their QMS. ONC has stated in the 2014 Edition Final Rule that this documentation should be submitted as part of certification testing and would become a component of the publicly available certification testing results. Core and Menu Set Requirements Although CMS redefined some of the core and menu set objectives, the total number required is unchanged. This was done to maintain a relatively consistent reporting burden across the first two stages of the program. Details of the core and menu set measures can be found in the four of the seven appendices in this document: Appendix A: Quick Guide Comparison Stage 1 to Stage 2 Related Research Meaningful Use The White Board Story (March, 2012) Updated Final Rule version Updated of Final this wall Rule poster version to of be this wall published poster to be in early September, published in 2012 mid- September 2012 Appendix B: Changes to Stage 1 Measures Appendix C: Comparison of NPRM to Stage 2 Final Rule Core and Menu Set Measures Appendix D: Required Data Elements to Meet EHs/CAHs and EPs View, Download or Transmit Measures Number of Core and Menu Set Objectives in Stage 1 and Stage 2 Provider Core Stage 1 Final Menu Set* Total Objectives Core Stage 2 Final Menu Set * Total Objectives Eligible Hospitals Eligible Professionals 14 5 of of of of 6 20 *New in Stage 2, CMS will no longer allow an exclusion to count toward a provider s met objectives in the menu set as it was allowed in Stage 1 unless the number of exclusions is greater than the number of total menu set measures that can be deferred. Stage 1 measures refined for 2013 While the total number of objectives remains the same, the rule employs what some might consider creative accounting to achieve this number. No Stage 1 measure is eliminated entirely. Instead, some of the stand-alone measures from Stage 1 were

14 14 combined with other objectives to create more robust objectives overall in Stage 2. For example, problem list, medication list, and medication allergy list no longer exist as separate measures for Stage 2, but are listed as required elements that must be kept up-to-date in the summary of care record to be provided for more than 50% of transitions of care. Additionally, in order to meet this measure, providers must electronically transmit more than 10% of such transitions and referrals. Another measure refinement: while the Stage 1 requirement to test the exchange of key clinical information is eliminated, Stage 2 now requires that providers transmit 10% of summary of care records electronically. Finally, the objective to provide patients with an electronic copy of their health information is replaced with a requirement that gives patients access to infrastructure that allows them to view, download, and transmit their health information on a continuous real-time basis. CMS has revised some objectives that providers must meet to successfully demonstrate Stage 1 of the EHR Incentive Program in 2014; those changes to Stage 1 measures are detailed in Appendix B. Providers have the option to use the revised version of Stage 1 measures in 2013; however, meeting the revised Stage 1 measures will become mandatory for all providers in Stage 2 focuses on care coordination, patient engagement Related Research So You've Attested to Stage One of Meaningful Use Now What? (July 2012) CMS has finalized the following new requirements for providers demonstrating Stage 2. While this list does include Stage 1 measures that have been significantly modified, it does not include those with minor modifications, threshold increases, or those that have moved from the menu to core set. Core Set Objectives Automatically track medications using electronic medication administration records, or emar (EHs only) Leverage computerized provider order entry (CPOE) for medications, lab, and radiology orders Electronically transmit a summary of care record at transitions or referral Provide patients with the ability to view, download, and transmit health information Use secure electronic messaging to communicate with patients (EPs only) Menu Set Objectives Make imaging results and information accessible Record patient family history Report cancer cases to a cancer registry (EPs only) Report specific cases to a specialized registry (EPs only) Utilize eprescribing (EHs only) Record electronic notes Provide structured electronic lab results to ambulatory providers (EHs only) While the transition to Stage 2 will necessitate adoption of new technological capabilities, the greater impact will be on the staff and clinicians who must adopt new workflows necessary to meet the threshold requirements. Denominators based on only patients with records in the certified EHR eliminated in favor of those based on all unique patients In addition to evaluating new measures, providers must be cognizant of the changes to the numerators and denominators that providers will use to calculate their

15 15 performance on core and menu set measures. For example, CMS has eliminated the denominator calculation that counted only patients with EHRsin favor of one that counts all unique patients. This change will impact organizations that do not maintain all of their records for patients receiving care in POS 21 and POS 23 in their CEHRT. For example, patients with records maintained in a niche non-certified specialty system must now be included in meaningful use denominator calculations. Similarly, CMS has refined measure calculations. For example, in Stage 1 the CPOE denominator was based on the number of unique patients with a single medication in their medication list. In Stage 2, CMS has defined a much more rigid denominator for this measure that is based on the total number of medication, radiology, and laboratory orders. This change will significantly increase the denominator and in so doing will increase the level of effort required to meet the measure. Each order type will have its own numerator and denominator for attestation purposes. Electronic and batch reporting methods for Stage 2 In response to stakeholder public comments, CMS is finalizing the electronic reporting option for core and menu set measures for fiscal year (FY) or calendar year (CY) 2014 and beyond for any participants that are beyond Year 1. Electronic reporting of CQMs will be required starting in 2014, and large EP practices will be elated that CMS has finalized group reporting starting in EPs within a single group practice will also have the option to use a group reporting batch method to report all EPs individual metrics. Despite using the group reporting option to reduce administrative burden, each EP will still need to individually achieve meaningful use. CMS reiterated that Year 1 attesters would continue to be able to attest online and not be required to do electronic reporting in Year 1 of any of the EHR Incentive Programs. Introduction of EH/CAH and EP versions of an objective and measure Of note, for the first time since the CMS EHR Certification Program began, a single objective can appear in both the core and menu set differentiated by the provider type (EHs/CAHs versus EPs). There are two examples of this in Stage 2. The eprescribing measure is core set for EPs, and menu set for EHs/CAHs. Similarly, syndromic surveillance is core set for EHs/CAHs in Stage 2, but remains menu set of EPs in Stage 2. Another very significant difference in versions is the view, download, and transmit objective, whose measure depends on the provider type 36 hours for EHs/CAHs and days for the EPs. Of note, the Discharge Summary is not required to be available 36 hours after discharge. Significant change in the requirement to capture problems, medications, and medication allergies Beginning in 2014, as part of the measures view, download, and transmit, as well as for summary of care at transitions, the capture of a problem list is expected to be more robust to include a current problem lists, not just one problem on the problem list as was required in Stage 1. Additionally, current medication and current medication allergy lists must be made available. See Appendix D for all required data elements needed for EHs/CAHs and EPs to meet these measures in Stage 2.

16 16 Introduction of capturing cognitive and functional status as part of summary of care at transition In addition to the MU Common Data Set items described earlier, the following data elements will need to be captured as part of the summary of care at transition measure. CEHRT will be required to demonstrate capture of these required data elements in the standard specified in order to become certified. The additional data elements required for the summary of care at transition measure are: Encounter diagnoses Immunizations Cognitive status Functional status The reason for referral and referring or transitioning provider s name and office contact information (ambulatory setting only) Discharge instructions (inpatient setting only) Of note, cognitive status and functional status have been added to this measure. These two data elements are not required for the view, download, and transmit measure.

17 17 Clinical Quality Measures Changes to CQM Requirements Expanding list of CQM options while maintaining the same total CQMs required for EPs, with an increase of 1 CQM for EHs CMS incorporated clinical quality measures into the definition of a "meaningful EHR user," rather than treating CQMs as a separate meaningful use core set objective. This resonates with the experience of providers in Stage 1 given that, even without thresholds, the magnitude of the CQM objective was immense relative to any single core or menu set objective. Beginning in 2014, EPs will submit nine of 64 approved CQMs from at least three of the six National Quality Strategy (NQS) domains listed below. EHs/CAHs will need to submit 16 of 29 approved CQMs at least three of the six NQS domains listed below. The list of approved CQMs was not published with the CMS final rule on September 4, 2012, but will be required to be posted no later than November 3, The NQS domains are: Patient and Family Engagement Patient Safety Care Coordination Population and Public Health Efficient Use of Healthcare Resources Clinical Process/Effectiveness For EPs in particular, CMS will increase the diversity of its CQMs to include quality measures that are relevant to additional specialties. Additionally, for providers starting an EHR Incentive Program in 2014, the CQMs for 2014 Edition will be the same as the Stage 1 CQM requirement. New and Revised to CQM Data Capture and Export Requirements Significant changes related to data capture requirements for CQMs will begin in EHR technology that is certified for a particular CQM must be capable of capturing data elements defined in the Explicit Data Capture List that is being developed by the National Library of Medicine. ONC and CMS believe that many of the historical problems with CQM reporting were due to the absence of accurate and complete data capture. Details are forthcoming in the new and yet-to-be released Data Element Catalog (i.e., the Explicit Data Capture List). Make no mistake about it: capturing CQMs is going to become unprecedented at the country level, both exciting to see as well as challenging to achieve. CMS and ONC specify the requirement in great detail that EHR technology developers must demonstrate each of the required data elements captured by the CEHRT. All participants in the CMS EHR Incentive Programs will now know the amount of data capture required, down to the exact data item, for each and every CQM. This eliminates the burden of sifting through hundreds of pages of specification documents to determine the required data elements for each and every CQM.

18 18 The introduction of the Explicit Data Capture List will be a significant improvement over the painful process that vendors and providers endured with the 2011 Edition CQMs. In particular, many EHs/CAHs and vendors found the over 400-page specification document difficult to understand for the mandatory EHs/CAHs CQMs in the 2011 Edition. Another welcome change based on public comments is the elimination of the requirement for capturing detailed information on why a medication was not ordered or given. To ONC s knowledge, no EHR technology consistently captures the reason why a particular medication was not prescribed, nor do EHRs systematically make a distinction between patient reason, system reason, or medical reason. CMS will not require exclusions and exceptions criteria to be captured in the same way that was done using manual chart abstractions. The final rule requires EHR developers to demonstrate capture and export of the require data elements in order to become certified in CQM. Also due to numerous public comments, the CQM certification criteria are now in three distinct sections (c)(1) Clinical quality measures capture and export (c)(2) Clinical quality measures import and calculate (c)(3) Clinical quality measures electronic submission ONC has noted this new flexible approach to CQMs preserves portability and flexibility to offer EPs, EHs, and CAHs the option of using regional or national CQM calculation and/or reporting solutions, such as registries. Additionally, other types of data intermediaries could obtain an EHR Module certification for the services that they offer. Alignment with Other Reporting Initiatives Better reporting alignment no longer an open question In addition to identifying new measures, CMS seeks to align its measures with existing quality programs. For EPs, these programs include the Physician Quality Reporting System (PQRS), the CMS Medicare Shared Savings Program (MSSP), the National Committee for Quality Assurance (NCQA) for medical home accreditation, as well as those proposed under the Children's Health Insurance Program Reauthorization Act (CHIPRA) and under the Affordable Care Act (ACA) Section 2701 in In the final rule, CMS finalized the reporting options as proposed, showing great efforts to aligning its CQM reporting options with PQRS and MSSP. EPs that successfully demonstrate the submission of quality metrics in either program will simultaneously meet EHR Incentive Program CQM requirements. The selection of CQMs proposed for EHs and CAHs aligns with measures used by the Joint Commission, the Medicare Hospital Inpatient Quality Reporting Program and Hospital Value-Based Purchasing Program, and the National Quality Strategy. The goal of such alignment is to reduce duplication and redundancy. More details will unfold regarding the alignment when the final approved list of CQMs for 2014 Edition meaningful use is published by November 3, They are required to be published within 60 days after the release of the final rules on September 4, 2012.

19 19 Reporting Options Electronic reporting mandatory in 2014 for providers in Year 2 and beyond To minimize the overall reporting burden for providers and to lay a foundation for meaningful use of CQM data in Stage 3 and beyond, CMS has finalized electronic reporting options for eligible hospitals and eligible professionals. Beginning in 2014, EHs and EPs in Year 2 and beyond must submit CMQ data electronically. Of note, it is specified in ARRA 4 that the Secretary has the statutory right to not require the electronic reporting of information on clinical quality measures unless the Secretary (meaning CMS on behalf of the Secretary) can accept the information electronically, even if on a pilot basis. Eligible Hospitals Providers in Year 1 of meaningful use must continue to report the results of their selected CQM measures through the CMS online attestation method. In 2013, EHs have the option to participate in CMS electronic reporting pilot as an alternative to the standard attestation method outlined in Stage 1. However, starting in 2014, providers in Year 2 and beyond will be required to use one of the two methods presented in the table below. Note that to avoid payment adjustment in 2015, the providers in Year 1 of the program must submit the CQM data by the attestation method by July 1, EH CQM Reporting Options Starting in 2014 Option Description Data Level Data Standard Option 1 Submit the selected 16 CQMs on an aggregate basis through a CMSdesignated transmission method using CEHRT Aggregate data regardless of payer QRDA-III format Option 2 Submit the selected 16 CQMs on a patient-level basis in a manner similar to the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot for Eligible Hospitals and CAHs using CEHRT; as long as the CQM data originates from CEHRT, it may be submitted directly from the hospital's CEHRT to CMS or through a data intermediary to CMS. Patient level data sampling of all payers QRDA-I format (release 2) CMS has also finalized a case threshold exemption to minimize the burden on hospitals to report on CQMs for which they have insufficient cases. In order to align with the Hospital Inpatient Quality Reporting (IQR) Program, CMS will adopt the following policy for all eligible hospitals and CAHs participating in the EHR Incentive Program. Hospitals will be exempt from reporting on a specified CQM if, as defined by a CQM s denominator population: A hospital has five or fewer inpatient discharges per quarter or A hospital has 20 or fewer inpatient discharges per year 4 American Recovery and Reinvestment Act, Sections 1848(o)(2)(B)(ii) and 1886(n)(3)(B)(ii)

20 20 The above discharges include accounting for Medicare and non-medicare cases. This exemption starts to take effect in 2014 and applies to EHs in all stages of meaningful use, except for those that are in their first year of the program. Eligible Professionals In 2013, EPs can report CQMs either through the standard attestation approach, or through participation in CMS s electronic reporting pilot. Starting in 2014, EPs must transition to one of the electronic reporting options shown in the table below. Similar to EHs, EPs that are in Year 1 of the program in 2014 will continue to submit CQM results via the Medicare CMS online attestation tool. The states control the reporting options for the Medicaid EHR Incentive Program and reporting methods will vary by state. To avoid payment adjustments in 2015, the providers in Year 1 of the program must submit the CQM data by October 1, 2014, a full three months earlier than those participants in year 2 and beyond. EP CQM Reporting Options Starting in 2014 Option Description Data Level Data Standard Option 1* Aggregate reporting through a CMSdesignated electronic transmission method using CEHRT Aggregate data regardless of payer QRDA-III format Option 2 Patient-level reporting via PQRS through the transmission methods established for the PQRS EHR-based reporting mechanisms and using CEHRT Patient level data only Medicare patients as required under the PQRS program QRDA category I (release 2) * EPs reporting via option 1 would need to log into the CMS portal and upload a document in a QRDA-III format, which is XML-based. Two options allowed for CQM group reporting CMS has also finalized two group-reporting options as alternatives to the current individual reporting method for CQMs used by EPs. These options will apply only to groups of providers for which all participants are attesting to Year 2 or beyond. Medicare EPs taking part in the MSSP: Medicare EPs in a group practice that is participating in the shared savings program or in the testing of the Pioneer ACO model, and who submit Accountable Care Organization (ACO) measures according to MSSP requirements, will simultaneously meet EHR Incentive Program CQM requirements, provided that the data in use is abstracted from the CEHRT. Medicare EPs taking part in PQRS: Medicare EPs that successfully report under PQRS Group Practice Reporting Option (GPRO) using a certified EHR will simultaneously satisfy requirements for the EHR Incentive Program. Note that the proposed claims and registry options under GPRO would not satisfy this requirement because they do not involve the use of CEHRT. Clarification for first year EPs regarding payment adjustments

21 21 CMS provides a caveat: a group can include CQM data collected from the EPs attesting in their first year as part of the group s collective data submission. However, to avoid payment adjustment, first-year EPs must individually submit their CQM data by attestation and are not allowed to use either of the group reporting methods to demonstrate meaningful use. Medicare Payment Adjustments In the proposed Stage 2 Rule, CMS outlined a number of critical clarifications to their plans for levying payment adjustments beginning in After deliberating on public comments, CMS decided to finalize the regulations for payment adjustments as proposed with only a minor correction. In general, EHs and EPs will be subject to payment adjustment in FY 2015 if they fail to demonstrate meaningful use in FY 2013 or do not successfully attest by three months before the end of FY or CY 2014, respectively. There are a number of differences between EHs and EPs in the determination of payment adjustment rates in 2015 and beyond. Eligible Hospitals EH IPPS reimbursement adjustments start in FY 2015 EHs failing to demonstrate meaningful use will face payment adjustments in the form of a reduction to the update of their Inpatient Prospective Payment System (IPPS) standardized amount starting in FY The following schedule specifies percent reduction in the IPPS update. EH Payment Adjustments Starting in 2015 Eligible Hospital Payment Adjustment Percentages Starting in Fiscal Year (FY) 2015 FY 2015 FY 2016 FY 2017 and subsequent years Reduction in Market Basket Adjustment if an EH is not a meaningful user (i.e., fails to meet any of the meaningful use measures), but meets the CQM requirements Reduction in Market Basket Adjustment if an EH is not a meaningful user and fails to meet the CQM requirements 25% 50% 75% 50% 75% 100% Additionally, If EHs/CAHs fail to submit CQM data, the percentage adjustment to the IPPS update will increase by another quarter of the applicable percentage. CMS incentive payments link to the organizations unique Certification Number (CCN). CMS will use the CCN identifier to determine and levy payment adjustments as well. As noted in the table above, there will be payment adjustments based on compliance with meaningful use measures, and additional payment adjustments related to CQMs. As a result, hospitals that do not successfully achieve meaningful use and/or CQMs will receive payment adjustments(s) for all payments made to that CCN under the IPPS during the payment adjustment year.