HITECH MEANINGFUL USE

SUMMARY OF KEY PROVISIONS IN FINAL RULE FOR STAGE 2 HITECH MEANINGFUL USE Global Institute for Emerging Healthcare Practices Current as of November 28, 2012 Key Points The final rules for Stage 2 requirements for meaningful use and electronic health record (EHR) standards and certification were released by the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator (ONC), respectively, on August 23, 2012. Much of the content in the final rule is in line with how Stage 2 was described in the Notice of Proposed Rule Making (NPRM) released in February 2012. Despite much comment from the industry on the complexity and number of requirements for meaningful use, the list for both eligible professionals (EPs), eligible hospitals (EHs) and critical access hospitals (CAHs) remains about the same, though many are carried over from Stage 1, but with a much higher threshold of minimum level of use. The final rule gives participating providers more time to meet Stage 2 requirements through a combination of allowing providers still working to achieve Stage 1 the ability to use 2011-certified technology through 2013, giving 2011-attesting provider organizations another year to achieve Stage 2 (2014 instead of 2013), and defining the EHR reporting period for both meaningful use and clinical quality measure (CQM) reporting for Stage 2 in 2014 as three months, rather than one year. Overall participating providers have more options in terms of which measurement approach to use for some meaningful use criteria and when to transition to electronic reporting of CQMs, and, for those organizations still working to achieve Stage 1 meaningful use, even whether to employ 2011- or 2014-certified EHR technology. For providers, this will require more (sometimes inter-related) decisions to sort out the right path; vendors of Certified EHR Technology (CEHRT) will have to be able to support every path. We acknowledge that the transition to upgraded EHR technology will be a challenge for all parties involved. Due to several interrelated factors addressed by ONC and CMS to relieve regulatory burden in our respective final rules, we have respectively included certain new flexibilities for EPs, eligible hospitals, and CAHs in order to allow for a more reasonable transition to the upgraded technology. Final rule The final rules for Stage 2 of the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs were released by the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator (ONC), respectively, on August 23, 2012. These specify the meaningful use criteria that eligible professionals (EPs), eligible hospitals (EHs) and critical access hospitals (CAHs) must meet in order to continue to participate in the program, the certification requirements for EHR technology that qualifies for use in the program, and the data and transmission standards to be incorporated into the Certified Electronic Health Record Technology (CEHRT) providers are to use in achieving meaningful use. This paper provides a summary of the key provisions. EHR Reporting Periods and Timeline The original timeline established in the regulations for Stage 1 would have required providers who attested to meaningful use in 2011 to meet Stage 2 in 2013. For EPs, the required one-year reporting period would have started on January 1, 2012, for hospitals on October 1, 2012. Clearly some adjustment was needed. In the final rule, time was added for the transition to Stage 2 in several ways. Early (2011) attesters now have until 2014 to meet Stage 2. Since this is still only 18 months away, the EHR reporting period for demonstrating meaningful use and measuring CQMs for 2014 only was shortened to three months for providers to achieve any stage of meaningful use (as opposed to the full year in the original timeline for Stage). Those providers still working to achieve Stage 1 can continue to use 2011 CEHRT through 2013, rather than being required to upgrade to the 2014 version, although they have the option to do so.

Table 1. Stages of Meaningful Use Criteria by First Payment Year First Payment Year Stages of Meaningful Use 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2011 1 1 1 2* 2 3 3 TBD TBD TBD TBD 2012 1 1 2* 2 3 3 TBD TBD TBD TBD 2013 1 1* 2 2 3 3 TBD TBD TBD 2014 1* 1 2 2 3 3 TBD TBD 2015 1 1 2 2 3 3 TBD 2016 1 1 2 2 3 3 2017 1 1 2 2 3 *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. A helpful shorthand way of summarizing the table above is to recognize that, with the exception of those who qualified for payments in 2011, providers have two years in each stage before the bar is raised and an upgrade to the next level of CEHRT is required. The final rule also clarified Medicare payment adjustments set to kick in for providers not meeting meaningful use. Any provider demonstrating meaningful use in 2013 will avoid payment adjustment Any provider that first demonstrates meaningful use will avoid the penalty if they complete registration and attestation by July 1, 2014 (hospital) or October 1, 2014 (EP) Meaningful use attestations for Medicaid by any EP eligible for both programs, but who opted for the Medicaid program, will be accepted to avoid the Medicare penalty For Stage 2: EPs must complete 17 core and three menu objectives. EHs and CAHs must complete 16 core and three menu objectives. Meaningful Use Criteria Nearly all of the requirements spelled out in the proposed rule were retained. The final Stage 2 criteria for meaningful use adhere to the same structure of core (required) objectives and a menu of optional objectives used in Stage 1. EPs must complete 17 core and three of six menu objectives for a total of 20 objectives. (see Tables 2 and 3) EHs and CAHs must complete 16 core and three of six menu objectives for a total of 19 objectives. (see Tables 4 and 5) The raw numbers of objectives, however, don t truly reflect the effort involved. Most Stage 1 objectives were carried over into Stage 2 (with higher thresholds of use), but several quite challenging ones most notably problem list, allergy list and medication list have been merged into a new Stage 2 objective, the Summary Record of Care. Although these data capture requirements no longer appear as distinct criteria, the data involved (along with many other new data elements) are required fields in the Summary Record of Care. As indicated consistently in prior rulemaking, all menu objectives (except one) in Stage 1 are now core requirements in Stage 2. (CMS also signals in the rule that Stage 2 menu items will become core objectives in Stage 3.) For hospitals, there are two new core objectives. One objective using emar and assistive technologies to track medications from order to administration will require major workflow changes in both nursing and pharmacy (certification requires the use of automation and assistive technology such as bar coding to perform five rights checking). Hospitals must also provide patients with online access to information about their hospital stay. EPs have two new core objectives, both relating to patient engagement using health information technology. In addition to an objective similar to the hospital one giving patients online access, they must engage in secure messaging with Summary of Key Provisions in Final Rule for Stage 2 HITECH Meaningful Use 2

patients. All of the new patient engagement objectives have measures that require active participation on the part of patients by sending a message (EP) or viewing, downloading or transmitting the health information made available online (EP and hospital measures for online access). In all cases, CMS lowered proposed thresholds to 5% of patients in response to concerns raised by providers during the comment period. One objective carried over from Stage 1 as discussed above appears much more challenging when standards and certification requirements are taken into account. CEHRT will need to report patient problem list in SNOMED CT rather than having the option to use ICD-9-CM, ICD-10-CM, or SNOMED CT as in Stage 1. SNOMED CT is not currently in use by most providers. Although the rule does not preclude the use of interface terms, local terms, or other terms from being displayed to a healthcare provider in lieu of SNOMED CT to find, select, or view a patient s problem list, nonetheless the CEHRT will have to be able to store it that way, and use it in calculating CQMs (ICD-9-CM or ICD-10-CM are not an option for calculating CQMs in 2014 certification). The lack of publicly available mapping tools will add to the challenge of this transition. Table 2. Summary of Stage 1 and Stage 2 Core Meaningful Use Objectives and Measures for Eligible Professionals (Based on Stage 2 Final Rule) Stage 1 Menu Items That Have Moved to Core Requirements Are Italicized Core Objective Stage 1 Measure Stage 2 Measure CPOE e-rx Drug formulary check Provide summary of care record for transitions or referrals to another setting of care or provider Up-to-date problem list of current and active diagnoses Active allergy list Active medication list Demographics Vital signs Smoking status Clinical decision support rules Drug-drug and drug-allergy checking Table 2 continues >30% of all patients seen with medication orders have at least one of these via CPOE >40% of all permissible prescriptions written by the EP are transmitted electronically using certified EHR technology Drug-formulary checks implemented with access to at least one internal or external formulary for entire reporting period Performed at least one test of certified EHR technology s capacity to electronically exchange key clinical information >80% of patients seen have at least one entry (or indication of none) recorded as structured data >80% of patients seen have at least one entry (or indication of none) recorded as structured data >80% of patients seen have at least one entry (or indication of no allergies) recorded as structured data >50% of patients seen during the reporting period have demographics recorded as structured data (preferred language, gender, ethnicity, date of birth) >50% of patients 2 years old seen have height, weight and BP recorded as structured data Display system-calculated BMI (pt 2years old) Display system-generated growth chart, including BMI (pt 2-20 years old) >50% of patients 13 years old admitted have smoking status recorded as structured data At least one CDS rule relevant to specialty or high clinical priority has been implemented during the reporting period along with the ability to track compliance with that rule Drug-drug, and drug-allergy checking have been enabled during the reporting period >60% of all medication orders >30% of lab orders >30% of all radiology orders written by the EP during the reporting period are recorded using CPOE >50% of all permissible prescriptions, or all prescriptions written by the EP during the reporting period, are queried for a drug formulary and transmitted electronically >50% of patient transitions or referrals to another setting or provider had a summary of care record provided >10% of patient transitions or referrals to another setting or provider had a summary of care record provided either (a) electronically transmitted using CEHRT to a recipient or (b) where the recipient receives the summary of care record via exchange facilitated by an NwHIN Exchange participant or in a manner consistent with governance mechanism ONC establishes for the nationwide health information network Conducts one or more successful electronic exchanges of a summary of care document either with a recipient who has EHR technology that was developed or designed by a different EHR technology developer than the sender s CEHRT or with the CMS-designated test EHR during the reporting period >80% of patients seen during the reporting period have demographics recorded as structured data (preferred language, sex, race, ethnicity, and date of birth) >80% of patients seen during the reporting period have blood pressure (for patients age 3 and over only) and height/length and weight (for all ages) recorded as structured data. Display system-calculated BMI (pt 2years old) Display system-generated growth chart, including BMI (pt 2-20 years old) >80% of patients 13 years old seen during the reporting period have smoking status recorded as structured data Five CDS rules related to four CQMs have been implemented for the reporting period (otherwise, must be related to high-priority health conditions) Drug-drug and drug-allergy interaction checks have been implemented and enabled for the entire reporting period Summary of Key Provisions in Final Rule for Stage 2 HITECH Meaningful Use 3

Table 2 continued Core Objective Stage 1 Measure Stage 2 Measure Incorporate clinical laboratory test results Generate lists of patients with specific condition Patient reminders Clinical summary Provide patients the ability to view online, download, and transmit their health information Provide patient-specific education resources Use secure electronic messaging to communicate with patients on relevant health information Perform medication reconciliation when receiving a patient from another setting or provider of care of for any relevant encounter Capability to submit electronic data to immunization registries or immunization information systems in accordance with applicable law and practice Protect electronic health information created or maintained by the CEHRT through the implementation of appropriate technical capabilities >40% of all clinical lab tests ordered with positive/negative or numeric results are incorporated as structured data Generate at least one report listing patients with a specific condition >20% of all unique patients 65 years or older or 5 years old or younger were sent an appropriate reminder during the reporting period >50% of patients with visits are provided with clinical summaries within 3 business days. >10% of all unique patients seen were provided timely (within 4 business days of being updated in the certified EHR technology) electronic access to their health information subject to the EP s discretion to withhold certain information >50% of all patients of EP who request an electronic copy of their health information are provided it within 3 business days >10% of all unique patients seen are provided patient-specific education resources >50% of transitions in which the patient is transitioned into the care of the EP had medication reconciliation performed Performed at least one test of certified EHR technology s capacity to submit electronic data to immunization registries and follow up submission if the test is successful (unless none of the immunization registries to which the EP submits such information has the capacity to receive the information electronically) Conduct or review a security risk analysis per 45 CFR 164.308(a)(1) and implement security updates as necessary and correct identified security deficiencies as part of its risk management process >55% of all clinical lab tests results ordered by the EP during the reporting period whose results are either in a positive/negative affirmation or numerical format are incorporated as structured data Generate at least one report listing patients of the EP with a specific condition >10% of all unique patients who have had two or more office visits within the 24 months prior to the beginning of the reporting period were sent a reminder, per patient preference when available >50% of patients with visits (or patient-authorized representatives) during reporting period are provided with clinical summaries within 1 business day >50% of unique patients seen during the reporting period were provided timely (within 4 business days of the information becoming available to the EP) online access to their health information subject to the EP s discretion to withhold certain information >5% of unique patients seen by the EP during the reporting period (or their authorized representatives) view, download or transmit to a third party their information >10% of unique patients with visits during the reporting period were given patient-specific education resources identified by CEHRT >5% of unique patients seen during the reporting period sent a secure message using the electronic messaging function >50% of transitions into the care of the EP during the reporting period had medication reconciliation performed Successful ongoing submission of electronic immunization data from CEHRT to an immunization registry or immunization information system for the entire reporting period Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1), including addressing the encryption/security of data stored in CEHRT in accordance with requirements under 45 CFR 164.312 (a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security updates as necessary and correct identified security deficiencies Table 3. Summary of Stage 2 Menu Item Meaningful Use Objectives and Measures for Eligible Professionals (Based on Stage 2 Final Rule) Eligible Professionals Must Complete Three Objective Imaging results consisting of the image itself and any explanation or other accompanying information are accessible through CEHRT Record patient family health history as structured data Record structured notes in patient records Capability to submit electronic surveillance data to public health agencies Capability to identify and report cancer cases to a public health central cancer registry except where prohibited and in accordance with applicable law and practice Capability to identify and report cancer cases to a specialized registry (other than a cancer registry) except where prohibited and in accordance with applicable law and practice Stage 2 Measure >10% of all tests whose result is one or more images ordered by the EP during the reporting period were accessible through CEHRT >20% of unique patients seen during the reporting period have structured data entered for one or more first-degree relatives >30% of patients with at least one visit during the reporting period had at least one electronic progress note created, edited, and signed by the EP Electronic progress notes must be text-searchable. Non-searchable notes do not qualify, but this does not mean that all of the content has to be character text; drawings and other content can be included with searchable text notes under this measure Successful ongoing submission of electronic syndromic surveillance data from CEHRT to a public health agency for the entire reporting period except where prohibited Successful ongoing submission of cancer case information from CEHRT to a public health agency central cancer registry for the entire reporting period Successful ongoing submission of specific case information from CEHRT to a specialized registry for the entire reporting period Summary of Key Provisions in Final Rule for Stage 2 HITECH Meaningful Use 4

Table 4. Summary of Stage 1 and Stage 2 Core Meaningful Use Objectives and Measures for Eligible Hospitals and Critical Access Hospitals (Based on Stage 2 Final Rule) Stage 1 Menu Items That Have Moved to Core Requirements Are Italicized Core Objective Stage 1 Measure Stage 2 Measure CPOE Provide summary of care record for transitions or referrals to another setting of care or provider Up-to-date problem list of current and active diagnoses Active allergy list Active medication list Automatically track medications from order to administration Demographics Vital signs Smoking status Clinical decision support rules Drug-drug and drug-allergy checking Incorporate clinical laboratory test results Generate lists of patients with specific condition Provide patients the ability to view online, download, and transmit information about a hospital admission Provide patient-specific education resources Perform medication reconciliation when receiving a patient from another setting or provider of care or for any relevant encounter >30% of all patients admitted with medication orders have at least one of these via CPOE Performed at least one test of certified EHR technology s capacity to electronically exchange key clinical information between different legal entities using distinct EHRs >80% of patients admitted have at least one entry (or indication of none) recorded as structured data >80% of patients admitted have at least one entry (or indication of none) recorded as structured data >80% of patients admitted have at least one entry (or indication of no allergies) recorded as structured data >50% of patients admitted during the reporting period have demographics recorded as structured data (preferred language, gender, ethnicity, date of birth, cause of death, if applicable) >50% of patients 2 years old admitted have height, weight and BP recorded as structured data Display system-calculated BMI (pt 2 years old) Display system-generated growth chart, including BMI (pt 2-20 years old) >50% of patients 13 years old admitted have smoking status recorded as structured data At least one CDS rule relevant to specialty or high clinical priority has been implemented during the reporting period along with the ability to track compliance with that rule Drug-drug, and drug-allergy checking have been enabled during the reporting period >40% of all clinical lab tests ordered with positive/negative or numeric results were incorporated as structured data Generate at least one report listing patients with a specific condition >10% of all unique patients admitted provided timely (within 4 business days of being updated in the certified EHR technology) electronic access to their health information subject to the EP s discretion to withhold certain information >10% of all unique patients admitted are provided patient-specific education resources >50% of admissions had medication reconciliation performed >60% of all medication orders >30% of lab orders >30% of radiology orders written by authorized providers during the reporting period are recorded using CPOE >50% of patient transitions or referrals to another setting or provider had a summary of care record provided >10% of patient transitions or referrals to another setting or provider had a summary of care record provided either (a) electronically transmitted using CEHRT to a recipient or (b) where the recipient receives the summary of care record via exchange facilitated by an NwHIN Exchange participant or in a manner consistent with governance mechanism ONC establishes for the nationwide health information network Conducts one or more successful electronic exchanges of a summary of care document either with a recipient who has EHR technology that was developed or designed by a different EHR technology developer than the sender s CEHRT or with the CMS-designated test EHR during the reporting period >10% of medication orders created by authorized providers during the reporting period had administration of all doses tracked using assistive technologies in conjunction with emar >80% of patients admitted during the reporting period have demographics recorded as structured data (preferred language, sex, race, ethnicity, date of birth, and date and preliminary cause of death, if applicable) >80% of patients admitted during the reporting period have blood pressure (for patients age 3 and over only) and height/ length and weight (for all ages) recorded as structured data. Display system-calculated BMI (pt 2 years old) Display system-generated growth chart, including BMI (pt 2-20 years old) >80% of patients 13 years old admitted have smoking status recorded as structured data Five CDS rules related to four CQMs have been implemented for the reporting period. (Otherwise, must be related to highpriority health conditions) Drug-drug and drug-allergy interaction checks have been implemented and enabled for the entire reporting period >55% of all clinical lab tests results ordered by authorized providers during the reporting period whose results are either in a positive/negative affirmation or numerical format were incorporated as structured data Generate at least one report listing patients of the EP with a specific condition >50 of all patients discharged during the reporting period have their information available online within 36 hours of discharge >5% of patients discharged during the reporting period (or their authorized representatives) viewed, downloaded or transmitted their information to a third party) >10% of patients admitted during the reporting period were given patient-specific education resources identified by CEHRT >50% of patient admissions during the reporting period had medication reconciliation performed Summary of Key Provisions in Final Rule for Stage 2 HITECH Meaningful Use 5

Table 4 continued Core Objective Stage 1 Measure Stage 2 Measure Capability to submit electronic immunization data in accordance with applicable law and practice Capability to submit electronic reportable lab results to public health agencies Capability to submit electronic surveillance data to public health agencies Protect electronic health information created or maintained by the CEHRT through the implementation of appropriate technical capabilities Performed at least one test of certified EHR technology s capacity to submit electronic data to immunization registries and follow up submission if the test is successful (unless none of the immunization registries to which the hospital submits such information has the capacity to receive the information electronically Performed at least one test of the EHR system s capacity to provide electronic submission of reportable lab results Performed at least one test of certified EHR technology s capacity to provide electronic surveillance data to public health agencies Conduct or review a security risk analysis per 45 CFR 164.308(a)(1) and implement security updates as necessary and correct identified security deficiencies as part of its risk management process Successful ongoing submission of electronic immunization data from CEHRT to an immunization registry or immunization information system for the entire reporting period, except where prohibited Successful ongoing submission of electronic reportable lab results from CEHRT to public health agencies for the entire reporting period, except where prohibited Successful ongoing submission of electronic syndromic surveillance data from CEHRT to a public health agency for the entire reporting period except where prohibited Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1), including addressing the encryption/security of data stored in CEHRT in accordance with requirements under 45 CFR 164.312 (a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security updates as necessary and correct identified security deficiencies Table 5. Summary of Stage 2 Menu Item Meaningful Use Objectives and Measures for Eligible Hospitals and Critical Access Hospitals (Based on Stage 2 Final Rule) Hospitals Must Complete Three Objective Record whether a patient 65 years old or older has an advance directive Imaging results consisting of the image itself and any explanation or other accompanying information are accessible through CEHRT Record patient family health history as structured data Generate and transmit permissible discharge prescriptions electronically (erx) Record electronic notes in patient records Provide structured electronic lab results to ambulatory providers Stage 2 Measure >50% of unique patients 65 years of age admitted during the reporting period had advance directive status recorded as structured data >10% of all tests whose result is one or more images ordered by an authorized provider for patients admitted during the reporting period were accessible through CEHRT >20% of unique patients admitted during the reporting period have a structured data entered for one or more first-degree relatives >10% of hospital discharge medication orders for permissible prescriptions (for new, changed, and refilled prescriptions) are queries for a drug formulary and transmitted electronically >30% of patients admitted during the reporting period had at least one electronic progress note created, edited, and signed by an authorized provider Electronic progress notes must be text-searchable, non-searchable notes do not qualify, but this does not mean that all of the content has to be character text; drawings and other content can be included with searchable text notes under this measure >30% of electronic lab orders received have electronic structured lab results sent to the ordering provider Summary of Key Provisions in Final Rule for Stage 2 HITECH Meaningful Use 6

Reporting of Clinical Quality Measures Beginning in 2014, CMS is committed to streamlining reporting programs to reduce the burden on providers. What this means in practical terms is that measures will be aligned across programs (e.g., Shared Savings or ACO, PQRS, and HITECH) and opportunities provided to avoid multiple submissions to CMS. Although reporting CQMs is no longer a core objective of the EHR Incentive Program and listed as one of the meaningful use objectives, all providers are required to report on CQMs in order to demonstrate meaningful use. Clinical quality reporting is now tied to year, rather than stage. Regardless of the stage of meaningful use, all providers are subject to the expanded measure set in 2014 and beyond. Clinical quality reporting is now tied to year, rather than stage. Prior to 2014, Stage 1 measures will be continue to be reported, and EPs and EHs have the option of reporting via attestation or the ereporting pilot programs established by CMS. More information about e-reporting is available at the links below: https://www.qualitynet.org/dcs/contentserver?c=page&pagename=qnetpublic%2fp age%2fqnettier2&cid=1228771190900 http://www.cms.gov/outreach-and-education/medicare-learning-network-mln/ MLNProducts/downloads/PQRSMdcrEHRIncnPlt-ICN907867.pdf Clinical Quality Measure Requirements Provider Type Prior to 2014 2014* and Beyond Stage 2 EPs Complete 6 of 44 3 core (or alternate) 3 menu Complete 9 of 64 EHs and CAHs Report all 15 measures Complete 16 of 29 *Regardless of stage At least one measure in each of three NQS domains At least one measure in each of three NQS domains Regardless of the stage of meaningful use, all providers are subject to the expanded measure set in 2014 and beyond. Each EP will complete nine out of a list of 64 measures. CMS has recommended sets of nine core measures each for the adult patient population, the pediatric patient population and prioritized National Quality Strategy domains Eligible hospitals will complete 16 out of a list of 29 measures Both EPs and hospitals must choose at least one measure each in three of six National Quality Strategy domains HHS National Quality Strategy Domains Patient and Family Engagement Patient Safety Care Coordination Population and Public Health Efficient Use of Healthcare Resources Clinical Processes/Effectiveness Many of the proposed Stage 2 measures for EPs and hospitals were dropped. Updated specifications for the remaining measures were to be posted at or around the time of the final rule at the link below. https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/ QualityMeasures/ElectronicSpecifications.html In 2014, all Medicare-eligible providers in their second year and beyond of demonstrating meaningful use, must electronically report their CQM data to CMS unless the Secretary lacks the capacity to accept electronic transmission. In 2014 and beyond, both EPs and hospitals beyond the first year of demonstrating meaningful use have the option of electronically reporting results in aggregate for patients of all payers or patient-level data for Medicare-only patients. In 2014, providers in both Stage 1 and Stage 2 will have a 3-month reporting period for clinical quality measures. The reporting period for CQMs (measurement period) will generally be the same as the provider s respective EHR reporting period. For 2014, this means that providers in both Stage 1 and Stage 2 will have a three-month reporting period. This is only applicable that year, however. For 2015 and beyond, CMS has finalized the full year reporting period for EPs, EHs, and CAHs that are beyond their first year of demonstrating meaningful use. For the Medicaid program, states will continue to be responsible for determining whether electronic reporting or reporting via attestation is used. Summary of Key Provisions in Final Rule for Stage 2 HITECH Meaningful Use 7

Standards and Certification The final rule completes the ONC s second full rulemaking cycle to adopt EHR standards, implementation specifications and certification criteria. Providers now only need to have the CEHRT they need for the meaningful use stage they wish to meet. The key change in the final rule (referred to as the 2014 Edition of the Standards and Certification Criteria) is that it redefines the meaning of Certified EHR Technology. In the past, CEHRT was statically defined and driven entirely by the certification criteria. Now, what constitutes CEHRT is dynamically defined and driven by meaningful use. Under the new definition, providers only need to have the EHR technology they need in order to meet the meaningful use stage they wish to meet. (Note that the language has changed from Stage 1 CEHRT to 2011 CEHRT.) Key Additions and Changes to Certification Criteria Amendments In order to support HIPAA compliance, an EHR technology must be able to accept patient-supplied information in both free text and scanned format and append/amend it to the EHR. Encryption of data on end-user devices The new certification criterion requires any EHR technology that stores electronic health information on end-user devices to encrypt such information once it is no longer being actively used. (So this applies to how the technology creates temp files, manages cookies, caches data, etc.) View, download and transmit to third party CEHRT must include the ability to transmit an ambulatory and inpatient summary to a third party. It must include a patient accessible log to track the use of the view, download and transmit capabilities and make that information available to the patient. Cancer Case Information and Transmission to Cancer Registries CEHRT must have the capability to identify and report cancer cases to a State cancer registry (except where prohibited by law). In agreement with commenters, ONC has included this in the menu of options for EPs in Stage 2, rather than as a core requirement. Transitions of Care CEHRT must be able to do two classes of things: 1) receive, display and incorporate transition of care/referral summaries, and 2) create and transmit transition of care/referral summaries. Based on public feedback, and in the interest of providing backwards compatibility, ONC has revised its original proposal and now allows the use of CCD/C32 or CCR. Clinical Quality Measures The new certification standards adopt three new criteria relating to CQMs: 1) Electronic data capture and export. EHR technology must be able to record the data that would be required in order to calculate CQMs, and export the data in the event that an EP, EH, or CAH chooses to use a different certified EHR Module to perform the calculation of CQM results. 2) Electronic data import and calculation. EHR technology needs to be able to electronically import all of the data elements necessary to calculate CQMs for which it is to be certified. 3) The enabling of electronic submission of CQM data to CMS. EHR technology must be able to create for electronic transmission CQM results in a data file defined by CMS. This means putting the CQM results into an XML data file and being able to send it. ONC explains that the reason for the change is that some of the original CQMs were deemed not to be EHR-ready, meaning that there was some part of them that required doing something manually, or by hand. (One example they give is doing a chart abstraction.) ONC also stated that it expects to require tighter alignment with CDS and CQM in future editions of the EHR certification criteria. Summary of Key Provisions in Final Rule for Stage 2 HITECH Meaningful Use 8

Table 6. Comparison of 2011 and 2014 Standards Other Changes to the Certification Program The Temporary Certification Program will be sunsetted once the 2014 Edition final rule goes into effect. Also, the official name of the program is now the ONC HIT Certification Program. Comparison of 2011 and 2014 Standards There is nothing wholly unexpected in terms of vocabulary, transport and content standards. Everything ONC settled on was in line with what the HIT Standards Committee recommended in the development stages and the proposed rule. (See Table 6 below.) Category Area/Type 2011 Standard 2014 Standard Patient Summary Record Data Sharing Problem List Medication List Diagnoses and Procedures Race and Ethnicity Laboratory Drug Formulary Check Content Exchange 1. HL7 CDA R2, continuity of care document (CCD) or 2. ASTM E2369 std for continuity of care record (CCR) and adjunct to ASTM E2369 1. The code set specified in 45 CFR 162.1002 (a) (1) (ICD-9-CM Vols 1 and 2) or 2. IHTSDO SNOMED CT July 2009 Any source vocabulary that is included in RxNorm 1. The standard code set specified at 45 CFR 162.1002 (a)(2) (ICD-9-CM Vol 3) or 2. The standard code set specified at 45 CFR 162. 1002 (a)(5) (HCSPCS by HHS and CPT-4 by AMA) OMB Std Statistical Policy Directive No. 15 Oct 30, 1997 LOINC Version 2.27 when such codes were received within an electronic transaction from a laboratory Applicable Medicare Part D Standard (e.g., NCPDP 1.0) (EP s only) Electronic Prescribing Content Exchange 1. NCPDP Prescriber/Pharmacist Interface SCRIPT std and implementation guide (Version 8.1), or 2. NCPDP SCRIPT std (8.1) with implementation guide (Version 10.6) Electronic Submission (was Quality Reporting) Submission to Public Health Agencies Submission to Immunization Registries Vocabulary Any source vocabulary that is included in RxNorm Consolidated CDA, using 1) applicability Statement, 2) applicability Statement + XDR/XDM, or 3) SOAP RTM + XDR/XDM SNOMED CT + US Extension International Release January 2012 RxNorm in instances where EHR technology would be used to perform external transmissions ICD-10-CM for diagnoses and ICD-10-PCS for procedures OMB ISO 639-2 (constrained) LOINC version 2.38 Applicable Medicare Part D Standard (e.g., NCPDP 1.0) (EP s only) NCPDP SCRIPT Version 10.6 RxNorm Content Exchange CMS PQRI 2009 Registry XML Specification CMS PQRI 2009 Registry XML Specification Lab Results HL7 2.5.1 HL7 2.5.1 Lab Results Vocab Surveillance or Reporting LOINC Version 2.27 when receiving LOINC codes from Laboratory HL7 2.3.1 or HL7 2.5.1 LOINC version 2.38 HL7 2.5.1 + IG Content Exchange HL7 2.3.1 or HL7 2.5.1 HL7 2.5.1 + IG Vocabulary HL7 Standard Code Set CVX Vaccines Administered (July 30, 2009 version) CVX The ONC is planning to publish a standards resource page listing all of the adopted 2014 standards along with URLs to learn more about what they are and what they entail. About the Authors This paper was authored by Jane Metzger, Principal Researcher, and Jared Rhoads, Senior Research Specialist, in CSC s Global Institute for Emerging Healthcare Practices, the research arm of CSC s Healthcare Group. Summary of Key Provisions in Final Rule for Stage 2 HITECH Meaningful Use 9

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