Meaningful Use Stage 3 Proposed Rule: What it Means for Hospitals, Physicians & Health IT Developers

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1 Meaningful Use Stage 3 Rule: What it Means for Hospitals, Physicians & Health IT Developers Vernessa T. Pollard and Nicole Liffrig Molife April 2015 With the publication of the Stage 3 Meaningful Use Rule on March 30, ( Rule), the Centers for Medicare and Medicaid Services (CMS) propose new measures focused on promoting care coordination, improving patient access to health information and self-management tools, increasing the use of clinical decision support tools and computerized order entry systems, and facilitating comprehensive, interoperable patient data sharing among providers. CMS intends to streamline the meaningful use requirements by requiring all eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs) to meet a single set of meaningful use objectives and measures by CMS has raised the bar and imposes highlighted requirements, many of which will require providers to expand and modify their existing electronic health records (EHR) technology to meet these new proposed targets by EPs, eligible hospitals and CAHs who fail to meet the proposed Stage 3 requirements face payment reductions up to 5 percent. The proposed Stage 3 requirement also has implications for Health IT developers who are developing and marketing EHRs to EPs, eligible hospitals and CAHs. Meaningful Use is No Longer Just an EHR Incentive Program, It is a Payment Reduction Program While the American Recovery and Reinvestment Act of 2009 (P.L ) initially authorized CMS to provide incentive payments to EPs and hospitals participating in Medicare and Medicaid programs that adopt and meaningfully use certified EHR technology, the Act also mandated payment reductions for EPs, hospitals, and CAHs that were not meaningful users of certified electronic health record technology (CEHRT) under the Medicare program. EPs who were not meaningful users faced Medicare payment adjustments of up to two percent starting on January 1, 2015; and eligible hospitals and CAHs who were not meaningful users faced Medicare payment adjustments of up to 25 percent of the increase to the Inpatient Prospective Payment System (IPPS) payment rate starting on October 1, Starting in 2018, CMS proposes to require that all providers (EPs, hospitals, and CAHs) report for a full calendar year (CY), rather than the 90-day reporting period permitted in Stages 1 and 2, to avoid 1 80 Fed. Reg (Mar. 30, 2015) (to be codified at 42 C.F.R. pt. 495). 1

2 Medicare payment reductions. Providers attesting under the Medicaid program still have the option of reporting a 90-day period for the first year of demonstrating meaningful use. Stage 3 - The Last Stop on the Meaningful Use Track Today, providers are complying with different stages of meaningful use. Each stage (Stage 1 and Stage 2) has its own set of requirements that must be met in order to demonstrate meaningful use. The requirements become more rigorous as EPs and eligible hospitals proceed through the stages. 2 Stage 3 is expected to be the final stage when the regulation is finalized. 3 According to the Rule, all providers 4 will use Stage 3 meaningful use requirements starting in 2018, regardless of their previous stage of participation. Providers have the option to begin attesting under Stage 3 in Certain significant proposals include: The menu set objectives are replaced in Stage 3 by a single set of eight objectives with measures tailored to EPs or eligible hospitals and CAHs. o All the measures for Objectives 1 through 5 are required. o For Objectives 6 and 7, providers are required to attest to: (1) using all three measures, and (2) successfully meeting two out of the three measures. o For Objective 8, EPs must attest to three of the measures numbered one through five. Eligible hospitals and CAHs must attest to four out of the six measures. All providers (EPs, eligible hospitals, and CAHs) must report for an entire calendar year their first year, rather than the 90-day first year reporting period allowed in Stages 1 and 2. Providers attesting under the Medicaid program still have the 90-day option for their first year of reporting. All providers will report and be subject to adjustment on a calendar year (CY) basis. Previously, eligible hospitals reported based on the fiscal year (FY). Measures in Stage 1 and 2 that allowed for paper-based actions will be removed or transitioned to an electronic format utilizing EHR functionality in Stage 3. 2 The Stage 1 final rule may be found at 75 Fed. Reg (July 28, 2010), and at 77 Fed. Reg (Sept. 4, 2012). 3 It is expected that this is the last incremental phase of the meaningful use requirements. Further refinement and regulation may occur. 4 This advisory uses the term providers to mean EPs, eligible hospitals, and CAHs consistent with the Rule. 2

3 All providers will be required to use the 2015 Edition of certified EHR technology beginning in Raising the Bar with and Enhanced Measures in Stage 3 CMS proposes a cohesive set of eight required objectives and associated measures. CMS aggregated many of the previous stage requirements under eight broad policy areas. In determining which eight policy areas represent the advanced use of EHR technology and align with the program s foundational goals and overall national health care improvement goals, CMS conferred with the Joint Health IT Policy and Standards Committee. 5 The eight key policy areas/objectives are: (1) protect patient health information; (2) electronic prescribing (erx); (3) clinical decision support (CDS); (4) computerized provider order entry (CPOE); (5) patient electronic access to health information; (6) coordination of care through patient engagement; (7) health information exchange (HIE); and (8) public health and clinical data registry reporting. According to CMS, over 300,000 EPs have successfully demonstrated meaningful use as of February 2015, 6 and 90 percent of eligible hospitals achieved meaningful use by fiscal year 2014 at varying stages of meaningful use. 7 In the Rule, CMS raises the bar by creating new measures and imposing highlighted requirements on providers, many of which will require providers to expand and modify their existing CEHRT to meet these new standards. The Stage 3 Measures require providers to: Meet significantly higher compliance rates for several measures from the requirements; Protect electronic protected health information (ephi) through administrative, physical, and technical safeguards and to conduct a security risk analysis of its CEHRT upon installation of CEHRT, or an upgrade to a new edition of CEHRT, and risk analysis of its CEHRT and administrative, physical, and technical safeguards on an annual basis; Incorporate an electronic summary of care document that is transmitted to and received by the provider into its CEHRT; 5 80 Fed. Reg. at EHR Incentive Programs February 2014 Summary Report, Guidance/Legislation/EHRIncentivePrograms/Downloads/February2015_SummaryReport.pdf (last visited April 9, 2015). 7 Joint Health IT Policy and Standards Committee Meeting, HealthIT.gov, (Feb. 10, 2015). 3

4 Accept and incorporate patient-generated health data or data from non-clinical settings into the provider s CEHRT; Create a summary of care record using CEHRT and electronically exchanging the record with other providers; Expand the CPOE function to include diagnostic imaging and permit only credentialed staff to perform CPOE functions; Demonstrate active engagement on public and clinical data reporting, which means the provider must be sending production data to, or in the process of moving towards sending such data to, a public health agency or clinical data registry; and Provide patient access to their health information within 24 hours of the information being available to the patients provider. For developers, Stage 3 will require updates and revisions to existing EHR systems to address and incorporate new clinical documentation and enhanced reporting functions. The ability to adapt EHR systems to qualify for CEHRT status will be a differentiating factor as providers evaluate and acquire new technologies. For a detailed list of the Stage 3 proposed objectives, measures, exclusions, and significant revisions from Stages 1 and 2, please refer to our meaningful use chart at the end of our advisory. Clinical Quality Measures Requirements Not Finalized in the Rule EPs, eligible hospitals, and CAHs are statutorily required to report on clinical quality measures (CQMs) to CMS using CEHRT in order to be considered a meaningful user to avoid a payment adjustment. In Stage 3, CMS proposes to continue the policy of establishing certain CQM requirements that apply for both the Medicare and Medicaid EHR Incentive Programs including a common set of CQMs and the reporting periods for CQMs in the EHR Incentive Program. 8 However, the proposed rule does not set forth specific Stage 3 CQM requirements. Instead, CMS wishes to finalize requirements for the various quality programs (including the EHR Incentive Program, PQRS, and Physician Compare) at one time to allow for better alignment of the programs and increase program efficiency and efficacy Fed. Reg. at

5 CMS also seeks to defer rulemaking on CQM requirements for eligible hospitals and CAHs in order to align the CQM reporting requirements for the Medicare and Medicaid EHR Incentive Program with the IPPS rulemaking. Comments CMS is soliciting comments on a number of aspects of the Rule. Comments are due to CMS on May 29, If you have any questions about any of the topics discussed in this advisory, please contact your Arnold & Porter attorney or any of the following attorneys: Vernessa T. Pollard Nicole Liffrig Molife *Victoria M. Wallace contributed to this article. She is a Syracuse University College of Law graduate employed at Arnold & Porter LLP. Ms. Wallace is not admitted to the bar Arnold & Porter LLP. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation. 5

6 Meaningful Use: Stage 3 Rule Chart Objectives: Objective 1-Protect Patient Health Information: Protect electronic protected health information (ephi) created or maintained by the CEHRT through the implementation of appropriate technical, administrative, and physical safeguards. Objectives: Hospitals and Objective 1-Protect Patient Health Information: Protect electronic protected health information (ephi) created or maintained by the CEHRT through the implementation of appropriate technical, administrative, and physical safeguards. Measure: Conduct or review a security risk analysis in accordance with the requirements under 45 CFR (a)(1), including addressing the security (to include encryption) of data stored in CEHRT in accordance with requirements under 45 CFR (a)(2)(iv) and 45 CFR (d)(3), implement security updates as necessary, and correct identified security deficiencies. or Expands beyond technical safeguards required in to include administrative (e.g., risk analysis, risk management, training and contingency plans) and physical safeguards (e.g., facility access controls, workstation security) requirements. Clarifies that the scope of the security risk analysis is more limited than what is required under HIPAA. None. Objective 2-Electronic Prescribing: Generate and transmit permissible prescriptions electronically (erx). Objective 2-Electronic Prescribing: Generate and transmit permissible discharge prescriptions electronically (erx). EP Measure: More than 80% of all permissible prescriptions written by the EP are queried for a drug formulary and transmitted electronically using CEHRT. Eligible Hospital Measure: More than 25% of hospital discharge medication orders for permissible prescriptions (for new and changed prescriptions) are queried for a drug formulary and transmitted electronically using CEHRT. Proposes frequency requirements for security risk analysis. Increases threshold from 50% in to 80% in Stage 3. Over-the-counter (OTC) medicines are still excluded. In, this measure included new, changed, and refill prescriptions ordered. The Stage 3 proposed measure would be limited to new and changed prescriptions. Over-the-counter (OTC) medicines are still excluded. Any EP who: (1) writes fewer than 100 permissible prescriptions; or (2) does not have a pharmacy within their organization and none of the pharmacies within 10 miles of the EP's practice location accept electronic prescriptions. Any eligible hospital or CAH that does not have an internal pharmacy that can accept electronic prescriptions and none of the pharmacies within 10 miles of the hospital or CAH accept electronic prescriptions. Objective 3-Clinical Decision Support: Implement clinical decision support (CDS) interventions focused on improving performance on high-priority health conditions. Objective 3-Clinical Decision Support: Implement clinical decision support (CDS) interventions focused on improving performance on high-priority health conditions. Measure 1: The EP, eligible hospital and CAH must implement five clinical decision support interventions related to four or more CQMs at a relevant point in patient care. Absent four CQMs related to an EP, eligible hospital, or CAH's scope of practice or patient population, the clinical decision support interventions must be related to high-priority health conditions. Increases threshold from 10% in to 20% in Stage 3. Modest revisions to language. Clarifies the scope of relevant points of care, and provides examples of permissible CDS. Maintains provider s clinical discretion and choice regarding the CDS most relevant to a provider s practice. None. Measure 2: The EP, eligible hospital, or CAH has enabled and implemented the functionality for drugdrug and drug-allergy interaction checks. N/A No modification to language of proposed measure. Any EP who writes fewer than 100 medication orders during the EHR reporting period. Objective 4-Computerized Provider Order Entry: Use computerized provider order entry (CPOE) for medication, laboratory, and diagnostic imaging orders directly entered by any licensed healthcare professional, Objective 4--Computerized Provider Order Entry: Use computerized provider order entry (CPOE) for medication, laboratory, and diagnostic imaging orders directly entered by any licensed healthcare professional, credentialed Measure 1: More than 80 percent of medication orders created by the EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency department are recorded using computerized provider order entry. Increases threshold from 60% in to 80% in Stage 3. Maintains that only credential staff may perform CPOE functions. Any EP who writes fewer than 100 medication orders during the EHR reporting period.

7 Meaningful Use: Stage 3 Rule Chart Objectives: credentialed medical assistant, or a medical staff member credentialed to and performing the equivalent duties of a credentialed medical assistant, who can enter orders into the medical record per state, local, and professional guidelines. Objectives: Hospitals and medical assistant, or a medical staff member credentialed to and performing the equivalent duties of a credentialed medical assistant, who can enter orders into the medical record per state, local, and professional guidelines. Measure 2: More than 60 percent of laboratory orders created by the EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency department are recorded using computerized provider order entry. Measure 3: More than 60 percent of diagnostic imaging orders created by the EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency department are recorded using computerized provider order entry. or Increases threshold from 30% in to 60% in Stage 3. Maintains that only credential staff may perform CPOE functions. Expands rule by changing language from radiology orders to diagnostic imaging orders, which includes other imaging tests such as ultrasound, magnetic resonance, and computed tomography in addition to traditional radiology. Any EP who writes fewer than 100 laboratory orders during the EHR reporting period. Any EP who writes fewer than 100 diagnostic imaging orders during the EHR reporting period. Threshold increased from 30% of radiology orders in to 60% of diagnostic imaging orders in Stage 3. Objective 5-Patient Electronic Access to Health Information: The EP provides access for patients to view online, download, and transmit their health information, or retrieve their health information through an application program interface (API) within 24 hours of its Objective 5-Patient Electronic Access to Health Information: The eligible hospital or CAH provides access for patients to view online, download, and transmit their health information, or retrieve their health information through an API within 24 hours of its Measure 1: For more than 80% of all unique patients seen by the EP or discharged from the eligible hospital or CAH inpatient or emergency department: (1) The patient is provided access to view online, download, and transmit his or her health information within 24 hours of its availability to the provider; or (2) The patient is provided access to an ONC-certified API that can be used by third-party applications or devices to provide patients access to their health information within 24 hours of its availability to the provider. Measure 2: The EP, eligible hospital or CAH must use clinically relevant information from CEHRT to identify patient-specific educational resources and provide electronic access to those materials to more than 35% of unique patients seen by the EP or discharged from the eligible hospital or CAH inpatient or emergency department. Maintains that only credential staff may perform CPOE functions. This measures is a consolidation of objectives from. Decreases transmittal time from 4 days in Stage 2 to 24 hours in Stage 3. Threshold increased from 50% in to 80% in Stage 3. Measure one provides two options. The first option is similar to the options in the rule. The second option uses API that may provide more functionality and offers an alternative to patient portals. **Note: This proposed measure has 3 alternates that represent different use cases for the CEHRT function to support view, download, and transmit and/or API functionality. Threshold increased from 10% in to 35% in Stage 3. (1) An EP with no office visits. or more of housing units with 4Mbps broadband (1) An EP with no office visits. or more of housing units with 4Mbps broadband

8 Meaningful Use: Stage 3 Rule Chart Objectives: Objective 6-Coordination of Care through Patient Engagement: Use communications functions of certified EHR technology to engage with patients or their authorized representatives about the patient s care. Objective 7-Health Information Exchange: The EP provides a summary of care record when transitioning or referring their patient to another setting of care, retrieves a summary of care record upon the first patient encounter with a new patient, and incorporates summary of care information from other providers into their EHR using the functions of the EHR. Objectives: Hospitals and Objective 6-Coordination of Care through Patient Engagement: Use communications functions of certified EHR technology to engage with patients or their authorized representatives about the patient s care. Objective 7-Health Information Exchange: The eligible hospital or CAH provides a summary of care record when transitioning or referring their patient to another setting of care, retrieves a summary of care record upon the first patient encounter with a new patient, and incorporates summary of care information from other providers into their EHR using the functions of the EHR. Providers must attest to all three measures but only successfully meet two of them. Measure 1: During the EHR reporting period, more than 25% of all unique patients seen by the EP or discharged from the eligible hospital or CAH inpatient or emergency department actively engage with the electronic health record made accessible by the provider. Measure may be met by either: (1) More than 25% of all unique patients view, download or transmit to a third party their health information; or (2) More than 25% of all unique patients access their health information through the use of an ONC-certified API that can be used by third party applications or devices. Measure 2: For more than 35% of all unique patients seen by the EP or discharged from the eligible hospital or CAH inpatient or emergency department, a secure message was sent using the electronic messaging function of CEHRT to the patient (or authorized representative), or in response to a secure message sent by the patient (or authorized representative). Measure 3: Patient-generated health data or data from a non-clinical setting is incorporated into the certified EHR technology for more than 15% of all unique patients seen by the EP or discharged by the eligible hospital or CAH inpatient or emergency department. Providers must attest to all three measures but only successfully meet two of them. Measure 1: For more than 50% of transitions of care and referrals, the EP, eligible hospital or CAH that transitions or refers their patient to another setting of care or provider of care: (1) creates a summary of care record using CEHRT; and (2) electronically exchanges the summary of care record. or Threshold increased from 5% in to 25% in Stage 3. The first option is similar to the measure. The second option, API, is new in Stage 3. Threshold increased from 5% in to 35% in Stage 3. Reason for increase is that in Stage 3 is that the measure numerator will include situations where providers communicate with other care team members using the secure messaging function. The Rule defines non-clinical setting to mean a setting with any provider who is not an EP, eligible hospital or CAH. This may include health and care-related data from nutritionists, physical therapists, occupational therapists, psychologists, and home health care providers as well as data obtained from patients themselves. In Stage 3, the summary of care documents must include the requirements and specifications included in the Common Clinical Data Set specified by ONC for certification to the 2015 Edition. (1) An EP with no office visits. or more of its housing units with 4Mbps broadband (1) An EP with no office visits. or more of its housing units with 4Mbps broadband (1) An EP who has no office visits during the EHR reporting period may exclude from the measure. or more of its housing units with 4Mbps broadband (1) An EP neither transfers a patient to another setting nor refers a patient to another provider. or more of its housing units with 4Mbp broadband

9 Meaningful Use: Stage 3 Rule Chart Objectives: Objective 8- Public Health and Clinical Data Registry Reporting: The EP is in active engagement with a PHA or CDR to submit electronic public health data in a meaningful way using certified EHR technology. Objectives: Hospitals and Objective 8- Public Health and Clinical Data Registry Reporting: The eligible hospital or CAH is in active engagement with a PHA or CDR to submit electronic public health data in a meaningful way using certified EHR technology. Measure 2: For more than 40% of transitions or referrals received and patient encounters in which the provider has never before encountered the patient, the EP, eligible hospital or CAH incorporates into the patient s record in their EHR an electronic summary of care document from a source other than the provider s EHR system. Measure 3: For more than 80% of transitions or referrals received and patient encounters in which the provider has never before encountered the patient, the EP, eligible hospital, or CAH performs clinical information reconciliation. The provider would choose at least 2 of the following 3 clinical information sets on which to perform reconciliations: Medication - review of the patient s medication, including the name, dosage, frequency, and route of each medication. Medication allergy - review the patient s known medication allergies. Current problem list - review of the patient s current and active diagnoses. EPs must attest to three of the measures 1 through 5.. Eligible hospitals and CAHs must attest to four of the measures 1 through 6.. Measure 1: Must be in active engagement with a public health agency to submit immunization data and receive immunization forecasts and histories from the public health immunization registry/immunization information system. Measure 2: Must be in active engagement with a public health agency to submit syndromic surveillance data. or In, action required by providers was limited to sending an electronic transmission of a summary of care document. The Stage 3 Rule expands the measure to receipt of a transmission. This proposal is designed to complete the electronic transmission loop. Incorporates objective for medication reconciliation and expands the options to allow for reconciliation of other clinical information such as medical allergies. The Objective had an ongoing submission requirement, which is replaced with an active engagement requirement in Stage 3. CMS proposes that active engagement may be demonstrated in either of two ways: (1) completed registration to submit data or (2) testing and validation. required ongoing submission, Stage 3 requires active engagement. required ongoing submission, Stage 3 requires active engagement as discussed above. (1) Any EP, eligible hospital or CAH for whom the total of transitions or referrals received and patient encounters in which the provider has never before encountered the patient, is fewer than 100 times during the EHR reporting period. or more of its housing units with 4Mbp broadband (1) Any EP, eligible hospital or CAH for whom the total of transitions or referrals received and patient encounters in which the provider has never before encountered the patient, is fewer than 100 times during the EHR reporting period. or more of its housing units with 4Mbp broadband Any EP, eligible hospital, or CAH if: (1) does not administer any immunizations to any of the populations for which data is collected by their jurisdiction s immunization registration or system; (2) operates in a jurisdiction for which no immunization registry or system is capable of accepting the specific standards required to meet the CEHRT definition; or (3) operates in a jurisdiction where no immunization registry or immunization information system has declared readiness to receive immunization data. Exclusion for EPs - Any EP who: (1) does not treat or diagnose or directly treat any disease or condition associated with a syndromic surveillance system in their jurisdiction; (2) operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data from EPs in the specific standards required to meet the CEHRT definition; or (3) operates in a jurisdiction where no public health

10 Meaningful Use: Stage 3 Rule Chart Objectives: Objectives: Hospitals and or agency has declared readiness to receive syndromic surveillance data from EPs. Measure 3: Must be in active engagement with a public health agency to submit case reporting of reportable conditions. Measure 4: Must be in active engagement to submit data to public health registries. Measure 5: Must be in active engagement to submit data to a clinical data registry. This is a new reporting option that was not part of. CMS states that public health agencies collect reportable conditions, as defined by state, territorial, and local PHAs to monitor disease trends and support the management of outbreaks. There has generally been low reporting compliance because providers do not know when or how to report. CMS is proposing this rule to support case reporting. The rule was broad in the use of the term specialized registry which encompassed both registry reporting to public health agencies and clinical data registries. The Stage 3 proposed rule splits public health registry reporting from clinical data registry reporting. The rule was broad in the use of the term specialized registry which encompassed both registry reporting to public health agencies and clinical data registries. The Stage 3 proposed rule splits public health registry reporting from clinical data registry reporting. Exclusion for eligible hospitals/cahs - Any eligible hospital or CAH that: (1) does not have an emergency or urgent care department; (2) operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data from eligible hospitals or CAHs in the specific standards required to meet the CEHRT definition; or (3) operates in a jurisdiction where no public health agency has declared readiness to receive syndromic surveillance data from eligible hospitals or CAHs. Any EP, eligible hospital, or CAH that: (1) does not treat or diagnose any reportable diseases for which data is collected by their jurisdiction s reportable disease system during the EHR reporting period; (2) operates in a jurisdiction for which no public health agency is capable of receiving electronic case reporting data in the specific standards required to meet the CEHRT definition; or (3) operates in a jurisdiction where no public health agency has declared readiness to receive electronic case reporting data at the start of the EHR reporting period. Any EP, eligible hospital or CAH that: (1) does not diagnose or directly treat any disease or condition associated with a public health registry in their jurisdiction; (2) operates in a jurisdiction for which no public health registry is capable of accepting electronic registry transactions in the specific standards required to meet the CEHRT definition; or (3) operates in a jurisdiction where no public health registry has declared readiness to receive electronic case reporting data at the start of the EHR reporting period. Any EP, eligible hospital or CAH that: (1) does not diagnose or directly treat any disease or condition associated with a clinical data registry in their jurisdiction; (2) operates in a jurisdiction for which no clinical data registry is capable of accepting electronic registry transactions in the specific standards required to meet

11 Meaningful Use: Stage 3 Rule Chart Objectives: Objectives: Hospitals and Measure 6: Must be in active engagement to submit electronic reportable laboratory results. or N/A This measure is available to eligible hospitals and CAHs only. Same as rule. the CEHRT definition; or (3) operates in a jurisdiction where no clinical data registry has declared readiness to receive electronic case reporting data at the start of the EHR reporting period. Any EP, eligible hospital or CAH that: (1) does not perform or order laboratory tests that are reportable in their jurisdiction; (2) operates in a jurisdiction for which no public health agency is capable of accepting the specific ELR standards required to meet the CEHRT definition; or (3) operates in a jurisdiction where no public health agency has declared readiness to receive electronic reportable laboratory results.

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