1. Overview of Meaningful Use Regulations and Implementation Issues January 7, 2010 Joel White Executive Director Health IT Now Coalition

2. Agenda Welcome Overview of Rules –IFR Standards, Implementation Specifications and Certification –Medicare –Medicaid Response –CSC –Halamka –AHA –MGMA Other Issues

3. Meaningful Use Overview Two Rules were released on December 30, 2009, to implement ARRA incentives for health information technology. 1. Interim Final Rule on EHR Standards, Specifications and Criteria: –Published in the Federal Register on January 13, 2010. –The rule takes effect on February 12, 2010. –Comments on the rule are due on March 14, 2010. –National Coordinator Blumenthal has indicated submitted comments will be reviewed seriously, and changes to the final rule will be made if appropriate. 2. Proposed Rule on Medicare and Medicaid incentives: –Published in the Federal Register on January 13, 2010. –Comments on the rule are due on March 14, 2010.

4. IFR Overview Criteria –Stage 1 – 2011 –Stage 2 – 2013 –Stage 3 – 2015 Standards Implementation Specifications Certification

5. IFR Definitions Definitions Standards. HHS has defined a standard to mean a “technical, functional, or performance-based rule, condition, requirement, or specification that stipulates instructions, fields, codes, data, materials, characteristics, or actions”. Certification. Certification must include not only that a technology meets standards and implementation specification but also that it meets (through testing and certification) certain capabilities like medication reconciliation. Different certification criteria apply for EHRs in ambulatory and inpatient settings. For example, discharge instructions would apply in an inpatient setting, but not an ambulatory setting. Electronic Health Record. The rule adopts the statutory definition that requires EHRs to include patient demographic and clinical health information, has the capacity to provide clinical decision support and CPOE, to capture and query information relevant to health care quality and to exchange and integrate information with other sources. EHR Module. The rule defines a module as any service, component or combination that can meet at least one certification criteria. An example is a software program that facilitates electronic exchange. The purpose of EHR modules is to use them in combination to qualify as certified EHR technology. HHS believes this will promote competition in a vibrant marketplace and lead to additional choice amongst health care providers. Disclosure. The rule adopts the HIPAA definition of disclosure. This is important for consistency. The definition is “the release, transfer, provision of access to, or divulging in any other manner of information outside the entity holding the information.”

6. IFR Overview The rule sets out standards, implementation specifications and certification criteria necessary for a complete certified electronic health record (EHR) and an EHR module. EHR modules are components of a complete EHR that achieve at least one certification criteria, such as for quality reporting or for an on line patient portal. In order to be certified, an EHR must be able to share information around certain clinical, administrative and privacy criteria as defined in the rule. The rule establishes 24 criteria categories for eligible providers and 22 criteria categories for hospitals. These criteria will support the capabilities EHRs must include to enable providers to access Medicare and Medicaid incentive payments as meaningful users of the technology In addition, and according to the statute, certified EHRs must include patient demographic information and must have the capacity to: provide clinical decision support; support physician order entry; capture and query quality information, and; electronically exchange health information.

7. IFR Criteria Stage 1 (2011). The 2011 criteria focus on electronically capturing health information in a coded format, and using it to track clinical conditions and for care coordination purposes. Stage 2 (2013). The 2013 criteria expand on Stage 1 to include continuous quality improvement at the point of care. Stage 2 will be defined in a subsequent rule. Stage 3 (2015). The 2015 criteria expand on Stage 2 to promote decision support for high priority conditions, patient access to self management tools, access to comprehensive patient data and improving public health. Stage 3 will be defined in a subsequent rule.

8. Stage 1 Criteria Functional Requirements: Computerized Provider Order Entry (CPOE), e-prescribing, implementation of drug-drug, drug-allergy, drug formulary checks, a patient health problem list and patient demographics, maintenance of an active medication list including allergies, tracking smoking status, incorporating clinical lab-test results as structured data, reporting quality measures to CMS or States, sending patient reminders, and implementing clinical decision support rules. Administrative Requirements: Check insurance eligibility for and submit claims electronically to public and private payers. Patient Access: Require patients be provided with an electronic copy of their health information upon request, timely electronic access to their health information, including lab results, and to receive an electronic copy of their discharge instructions. Patients must be provided with clinical summaries for each office visit. Interoperability: Capability to electronically exchange clinical information among providers of care and patient authorized entities and to provide a summary care record for each transition of care and referral. Privacy/Security: Protect electronic health information through the implementation of appropriate technical capabilities, including encryption standards, creation of audit trails, verification that information has not been altered in transit and a record of disclosures.

9. IFR Standards In general: There are primary standards and some fall back alternative standards and vocabulary governing information exchange. HHS views the standards process as iterative, with new standards to be adopted as needed. HHS recognizes its ability to unilaterally adopt subsequent standards with or without a recommendation from the National Coordinator. HHS recognizes the need for a standard vocabulary to promote interoperability. HHS states that standards will be increasingly more demanding over time and certified EHR technology will need to include more capabilities.

10. IFR Standards HHS has adopted standards in four categories: Vocabulary Standards: The rule uses standardized nomenclatures and code sets used to describe clinical problems and procedures, medications, and allergies such as SNOMED CT. Content Exchange Standards: The rule requires standards to share clinical information such as clinical summaries, prescriptions, and structured electronic documents. Transport Standards: The rule uses standards used to establish a common, predictable, secure communication protocol between systems. HHS has adopted Simple Object Access Protocol (SOAP) version 1.2 and Representational state transfer (REST) to provide standard ways for systems to interact with each other. Privacy and Security Standards: The rule requires encryption, provide cross enterprise authentication and allow electronic consumer access to records. The rule also requires an audit log and an accounting of disclosures, including date, time, patient and user ID and a description of the disclosure.

11. IFR Implementation Specifications Implementation specifications adopted by the rule include: – the Physician Quality Reporting Initiative 2008 registry for quality reporting; –HIPAA transactions standards including for eligibility for health plan transactions and health care claims or equivalent encounter information transactions; and –the CAHQ CORE standards.

12. IFR Certification The rule requires all products must gain new certification to qualify as EHR technology for meaningful use incentives. HHS will publish a separate rule to recognize a certification program or programs to replace the current certification process. HHS has indicated the new certification rule will be released “shortly”, and, in oral comments and the rule itself, HHS indicates it may authorize multiple bodies for certification or replace the CCHIT certification process.

13. IFR Comments Sought by HHS Are any of the adopted certification criteria insufficiently specific to be used to test and certify? Is the HIT industry ready to move to a single standard for patient summary records in time for Stage 2? Are the Stage 2 candidate standards realistic? What standards for EHRs can promote access for people with disabilities? What standards for EHRs can help prevent fraud and abuse? What thoughts are there for the Stage 2 standard to populate medication list information? Is the HL7 QRDA mature enough to support quality reporting for Stage 1? “Given the importance of implementation specifications and the analyses and field testing necessary to refine them, we do not believe, with the exception of the few mentioned below, that there are mature implementation specifications ready to adopt to support meaningful use Stage 1. We seek public comment on whether there are specifications that are industry-tested and would not present a significant burden if they were adopted.” What is the HIT industry’s experience using CAQH CORE Phase 1 with adopted HIPAA transactions standards?

14. IFR Comments Three criteria have no associated standards (medication allergy list, vital signs and units of measure), meaning free text or local vocabularies are OK. Is this meaningful for these criteria? Some criteria have a standard, and a fall back. In some cases (where LOINC codes have not been received from a lab), local or proprietary codes may be used. If one EHR uses the standard and another uses the fall back or a local or proprietary code, can they share information? Will this require a bridge or module? (For LOINC, the answer from HHS is no, local or proprietary will not have to be converted). Is it reasonable to expect that all the criteria can be met within a complete EHR? Or is it more likely there will be “mostly” complete EHRs and EHR modules to fill in the gaps?

15. IFR Questions Continued Will providers adopt and use an EHR with these criteria, or will this be viewed by them as additional burden and not as a problem solving tool? Will the criteria enhance clinical outcomes and reduce costs?

16. Medicare and Medicaid Proposed Rule Provider adoption of an EHR is voluntary, but adopters of a certified product who meaningfully use it will receive incentive payments through Medicare and Medicaid. Over time, those that don't adopt and use a certified EHR will face financial penalties in Medicare. Year one adopters must use a certified EHR for 90 continuous days to qualify for payments. In subsequent years, the use must be demonstrated for the full year.

17. Proposed Rule Medicare: EP and Hospital Meaningful User and eligible for payments if: –Demonstrates use in a meaningful manner –Demonstrates the technology provides for electronic exchange –Submits reports on quality measures to HHS Medicaid: EP and Hospital Meaningful User and eligible for payments if: –Engaged in efforts to adopt, implement or upgrade certified EHR technology –Demonstrates MU as defined by a State and approved by the Secretary –States may add additional objectives to the definition of meaningful use, but HHS will reject any additions to HER functionality –Hospitals deemed Medicaid eligible if they are a Medicare eligible meaningful use EP and Hospitals cannot get both payments and can switch programs only once per year.

18. CSC Survey of Hospital Readiness for Meaningful Use Progress Towards Readiness, By Category (All respondents) Use of a certified product …………………………………………….67% Current use of capabilities required for meaningful use………. 32% Adoption of standards……………………………………………….. 54% Quality management and reporting………………………………... 54% Privacy and security protection……………………………………. 73% Source: CSC, Are Hospitals Ready for Meaningful Use of EHRs?

19. CSC Survey Continued 70 percent of hospitals have systems capable of supporting Computerized Physician Order Entry (CPOE). Only eight percent have CPOE throughout the hospital with at least 75 percent of orders being entered by physicians. No hospital under 100 beds had CPOE up and running in even two units. None of the midsized hospitals (100 - 300 beds) in the survey had the system up and running throughout the hospital. Smaller hospitals have lower readiness scores especially for use of required applications and quality reporting. 54 percent are using the latest software version of their EHR product, which indicates upgrading might be required to meet the criteria for meaningful use. Although 89 percent report on core quality measures, only half capture the majority of the required data from their EHR system. The majority (98 percent) have a policy in place to limit the disclosure of protected health information, but only 52 percent employ encryption technologies to render data unreadable or unusable in the case of unauthorized access. Only 40 percent report that there is clear and broad awareness of the new civil and criminal penalties under the ARRA. Source: CSC, Are Hospitals Ready for Meaningful Use of EHRs?

20. Comments from John Halamka Chair, HITSP, Co-Chair, Standards Committee -- “These recommendations are consistent with the work of thousands of experts over the past decade. They do not include all the detailed recommendations from HITSP or implementation profile writers such as IHE but they do include all the highly mature constructs that are deployable in 2011 without over burdening the industry. From what I know about standards harmonization, the state of standards adoption, and the unresolved controversies/debates, the rule is the right mixture of harmonization and compromise. Not every stakeholder will be happy with it, but it is good enough. It moves us all forward toward the goal of less optionality, more constraints, and vocabulary controlled semantic interoperability.”

21. Comments from AHA “America's hospitals have serious concerns that the new health information technology rules severely limit hospitals' ability to access federal financing for health information technology that is used to improve patient care. “…the rules released yesterday create a stringent definition of 'meaningful use' that doesn't recognize these important efforts and would unfairly penalize many hospitals. A more commonsense approach would reward the progress hospitals and physicians already have made toward adopting EHRs. "In addition, the 'meaningful use' rule also fails to recognize how modern hospitals are organized and how care is delivered. Simply put, the eligibility requirements for hospitals and physicians are too restrictive. For example, health information technology payment incentives unfairly exclude physicians who practice in outpatient centers and clinics owned by a hospital. An alternate approach that recognizes all non-hospital physicians and the myriad of physician- hospital relationships would go a long way toward ensuring patient care is better coordinated and adoption of health information technology is rewarded. “Unless significant changes are made and timelines reexamined, it is unlikely that the vast majority of hospitals can meet the proposed standards, making them ineligible for this important funding, and also subject to penalties for not being in compliance. We urge CMS to make changes to these regulations that would advance the adoption and use of clinical information technology to improve care for patients and communities.“ Source: HDM News, January 4, 2010

22. Comments from MGMA "Overly burdensome requirements and needlessly complex administration will only discourage physician participation in the program and the implementation of EHRs," contended William Jessee, M.D., CEO and president of the Medical Group Management Association in a written response. Source: HDM News, January 4, 2010

23. Comments from HIMSS “The goals of President Obama's Health Information Technology for Economic and Clinical Health (HITECH) provisions included improvement in the quality and efficacy of health care delivered to Americans. The release on December 30th of interim final rules on meaningful use and qualified electronic health records begin us down the path to achieve those goals, goals that HIMSS has long supported. "With publication of the proposed regulations, eligible providers and hospitals now have specific guidelines to follow to earn their incentive payments from Medicare or Medicaid. It is important to recognize, as noted on the recent call conducted by ONC National Coordinator Dr. David Blumenthal, these are proposed regulations. Thus, all of us have time to review and offer suggestions, revisions and overall commentary. So, with that in mind, we look forward to reviewing these drafts to provide both analyses for our members and public comment responses for the federal government. "On first read of the proposed regulations, HIMSS believes that there is much more to applaud than criticize. We now have clarity of what technology functions constitute a qualified electronic health record; we now have a multi-year road map of future expectations; and we have certainty about many of the standards necessary to support practitioners' ability to improve patient care.” Source: HDM News, January 4, 2010