From the Chair: Evaluating HIT beyond EHR Certification

by Karen Bell, MD, MMS on November 19, 2012

For many clinicians, the concept of “certification,” especially when it comes to specialty boards of medicine, connotes passage of a highly rigorous and robust test after multiple years of training and study. The expectation that “certified” HIT connotes an equally high level of testing of patient care functionality is not surprising. The reality, however, comes into sharper focus when looking at the definition of certification — which is simply the assurance that certain defined characteristics are present. It can be done at the first level, which is nothing more than the developer’s personal word; at the second level, which involves an overarching organization of similar developers or persons attesting that the characteristics are present; or at the third level, which provides maximum confirmation through independent review, testing, assessment or audit. No matter what the approach, for HIT product certification to truly be of value to interested parties, those parties need clear knowledge of the rigor of the certification program, what it intends to accomplish and its criteria.

The goal of electronic health record (EHR) certification currently administered by the Office of the National Coordinator of Health Information Technology (ONC) is to assure providers that their EHR technology will meet minimum standards in support of Meaningful Use objectives and measures, thus meeting technical eligibility for incentive payments. This is done by a robust third level testing and certification program that meets this goal. There are other features and functions not included in ONC certification, however, that many providers may wish to consider using other evaluative methods.

First and foremost on the list of evaluative approaches beyond ONC certification would be integration testing to assure that all HIT related products can work together in a particular clinical environment. If products are not integrated, interfaces may need to be built between various modules or systems, adding significantly to cost. EHR users may need to find alternative ways to demonstrate that various system components can support functions relying on data integration.

Interoperability of one EHR with another and with entities to whom providers must report is also key. While some interoperability testing is inherent in the ONC certification program, more is required to assure access to critical information at the time it is needed. HealtheWay, a public-private partnership that has evolved from the ONC-developed Nationwide Health Information Network (now referred to as the eHealth Exchange), has partnered with the New York eHealth Collaborative-led EHR/HIE Interoperability Workgroup, a coalition of 15 states and 37 EHR vendors, to assure this more robust level of interoperability. CCHIT has been named the Compliance Testing Body for this partnership and will certify that the technical aspects of health information transport are met to enable reliable transfer of data within and across organizational and state boundaries.

Usability testing is still in its early phases. There is now universal agreement that usability in the HIT environment is characterized and informed by the science of user-centric design (UCD) and both formative (done as part of the development process) and summative (comparing one system with another using standardized formats) testing. Past CCHIT experience with objective testing that included reporting of usability ratings, current research on usability funded by ONC grants, and the practical application of new approaches to assessing usability will likely allow for more evaluation of HIT usability in the near future, with new usability ratings publically available. In the interim, the National Institute of Standards and Technology (NIST) has made a set of principles and guidelines that can be used to increase usability in the provider setting available on their website.

Every vendor and developer needs and wants to assure that they have incorporated state of the art security protections in their HIT. HIT users will need to keep in mind, however, that security testing and certification is not included for ONC certified modules that are certified separately from a “Base EHR.” While there is no question that most security breaches are the result of human activity, hackers continue to attempt to find financial information wherever they believe it to be — including provider and health plan settings. Providers must therefore rely on their vendors’ attestation that the highest level of security precautions has been implemented.

Patient Safety features are another area that has not been well defined, and no programs have been developed to specifically assure that they are included. However, we do know from reviews of malpractice claims that most are related to lack of communication and lack of follow up after a test, procedure, medication, or referral has been ordered. Providers should evaluate their own systems to be sure that multiple users in the clinical setting can access and use the record simultaneously, that data can be shared easily within the provider settings, with the patient, and with clinicians external to the provider system. They should also look for “closed loop ordering” functions: assuring that the system notifies the ordering clinician when there is no result, no followup, or no evidence of a prescription being filled as ordered.

Surveys offer some insight on how peers might evaluate a particular system. These are generally conducted by physician groups such as the American College of Physicians or propriety entities. While these do not include objective third part assessment, they can certainly provide indications of problems as well as particularly useful features of various products.

Lastly, as more and more provider groups — both physician and hospital based — look toward various models of Accountable Care, they should consider the fact that an EHR alone will not meet all their need for providing care that meets the Triple Aim of high quality, efficient cost, and strengthened patient relationships with available and access to care.

As it evolves, the HIT landscape is clearly becoming more and more complicated; ONC certification will continue to provide assurance that EHRs will meet Meaningful Use program goals through its various stages. This is an important first step when thinking and planning for the more robust HIT that will be necessary to care for patients effectively and efficiently in the future. Providers of all types will need to be mindful of other ways of assessing these technologies.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.

She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

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From the Chair: Meaningful Use Round Two, New Rules of Engagement

by Karen Bell, MD, MMS on October 15, 2012

(Reissued with corrections on October 17, 2012)

The rules for both Meaningful Use and the new Standards and Certification Criteria went into effect October 4, after the requisite 30 days since first posting in the Federal Register have passed. The initial flurry of reactions have subsided and interested parties of all stripes are now wrestling with the myriad devils that continue to reside in the details, along with a lot of questions, mainly around Certified EHR Technology (CEHRT).

One certification program ended on October 4; another began. EHRs certified to ONC 2011 Edition criteria by the temporary program or the permanent program, now the ONC HIT Certification Program, can be used until federal fiscal year 2014 for hospitals or calendar year 2014 for eligible providers attesting to Stage 1. EHRs certified to the new 2014 Edition criteria may also be used to attest to Stage 1 but test methods for that program won’t be ready until the end of this year. EHRs certified to the new 2014 Edition must be used whether you are attesting to Stage 1 or Stage 2 in FY/CY 2014. But you won’t need 2014 Edition CEHRT until you start your 90 day attestation period. All of these new rules are relatively confusing for a provider who is focused on caring for patients while attempting to play by the rules. Here are a few key points to guide successful attestations, using appropriately certified EHR technologies.

  1. If you already have an EHR that was certified to ONC’s 2011 Edition criteria you may use it without changes or upgrades until the 90 day period that you intend to designate as your attestation period for either Stage 1 or Stage 2 in 2014. This means up until July 1, 2014 if you are a hospital or October 1, 2014 if you are an eligible provider. You will, of course, want to upgrade it to the 2014 Edition certification sooner to be sure that you have all appropriate workflows in place by those dates.
  2. Starting October 4, 2012, health IT companies could continue to apply to certify their EHRs to the 2011 Edition criteria. According to a FAQ (PDF) issued by ONC on October 11, 2012, the implementation of a permanent program requirement that requires public access to both testing results and to some indication of the “total cost of ownership” of that EHR technology has been postponed until testing for 2014 Edition criteria is available. And ONC will only enforce these requirements for EHR technology certified by ONC-ABCs to these new 2014 Edition criteria. When implemented, the price transparency requirement would, for example, require that if a module is certified, the “total cost of ownership” might include interfaces between that module and others that would constitute a “complete” EHR.
  3. The new process also requires a complete separation between the entity doing the testing and the entity doing the certification. While this “firewall” may exist within one organization, as it does within CCHIT, it is possible for a vendor to go to one organization for testing and another for certification. Note that the ONC authorized Certifying Body (ONC-ACB) is the entity that is responsible for assuring that the products are certified to all of ONC’s requirements.
  4. A number of EHRs may be piloting direct electronic submission of Clinical Quality Measures to CMS in 2013. This functionality will be required for 2014 Edition EHRs but will not be part of any 2011 Edition certifications.
  5. The HIT community is awaiting a number of test procedures that will be released by ONC in “waves” and used by all Accredited Testing Laboratories (ATLs) for 2014 certification. Until they are all available, go through a two week public comment period, are revised as appropriate, and released as final, testing and certification to the 2014 Edition cannot begin. It will not begin until vendors have programmed all of the changes and made sure their products are safe and stable. 
    While some modules, tested and certified to one or a few criteria, may be out soon after the ONC 2014 Edition program is available, it may take several months for robust, fully integrated, EHR systems to have their new 2014 Editions ready for market and even longer to get all existing EHRs upgraded.
  6. The ONC 2014 Edition itself is quite different from the one currently in use.
    1. Everyone, eligible Provider or hospital, needs “Base” EHR technology. It can be one product or it can be several products or modules, each certifying to individual or sets of criteria. “Base” EHR includes 8 privacy and security criteria and 9 others including Demographics, Problem Lists, Medication Lists, Medication/Allergy Lists, CPOE, CDS, Data Portability, and 2 criteria for Transitions of Care.
    2. Depending on intended stage of attestation, everyone will also need either a set of criteria to support core Stage 1 measures or a set of criteria to support the core Stage 2 measures. Again, these can be integrated into a single vendor’s base product or can be purchased as separate modules from multiple vendors which may ultimately need to be interfaced with other modules.
    3. Everyone will need CEHRT for whatever menu objectives and measures they choose for their attestation as a third consideration.
    4. While not considered “core,” providers must choose among and are required to report a limited number of Clinical Quality Measures from the 64 possible eligible provider measures, or the 29 possible hospital measures, for successful attestation. The certification process with respect to these measures will include whatever measures the vendor chooses to bring to certification and will be displayed on ONC’s Certified HIT Products List.
    5. Privacy and security testing will be conducted on the Base EHR criteria only. Of the 15 new criteria, only data portability was included in the base and will thus be tested for privacy and security.

Many questions remain as we await the testing procedures. We will keep you informed as we learn more. In the interim, we are appreciative of the extra time given to all of us — providers, vendors, and testing and certification bodies alike — in the final rule. The 90 day attestation period for FY/CY 2014 should give everyone the time necessary to clarify any remaining questions, program the technology effectively, get it certified, and implement the necessary clinical workflows necessary for successful attestation.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.

She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

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From the Chair: Health Care Reform on a Sound Health IT Foundation

by Karen Bell, MD, MMS on June 12, 2012

As we await the Supreme Court’s decision on several aspects of the Patient Protection and Affordable Care Act (PPACA) one thing is clear: the concept of health care reform with respect to how the delivery system will be paid and will function in the future has already taken hold and is moving forward in both the private and public sectors.  While CMS supports Pioneer Accountable Care Organizations (ACOs) and a Medicare Shared Savings Program, payers across the country are working with organized health care systems of all sizes and description to develop contracts that put them at some degree of financial risk as an incentive to provide better, more efficient care.

Make no mistake — while the overarching principle of budgeted or predictable payment is reminiscent of the Health Maintenance Organization (HMO) capitation programs of the 1990’s, this new approach is truly different in that it holds the delivery system accountable for a very different set of goals and is not dependent on the type of insurance product that a patient may choose.  It is also different in that payers as well as physicians, hospitals, and other providers now understand that success is predicated on a culture of care that is patient focused and team oriented, exhibits good governance and leadership, and has a strong foundation of health information technologies (HIT).

The challenge is to understand what these three things entail for an organization and how to best implement them, recognizing that they are all related.  HIT in these organizations will need to go far beyond the basic Office of the National Coordinator (ONC) certified EHR, though even that may be difficult to acquire and adopt throughout the system without strong leadership.  Let’s also consider some of the other HIT approaches that will support success in meeting the objectives and goals to which the organization will hold itself.

At the onset, it’s important to recognize that a prospective ACO will need not only clinical HIT systems, but also financial management systems that can accommodate the new payment rules.  And the ACO will need updated operational systems as well.  Even more important is the need for these three types of HIT systems to integrate and work together — the lines between clinical, financial and operational work are no longer bright and distinct, especially in the critical area of business intelligence and analytics. Our current market, however, is dominated by products that focus on specified functions or areas of function.  It’s worth looking, therefore, at some key HIT functions while keeping an eye towards the grail of integration.

From a clinician’s perspective, EHRs loom large.  As noted, however, the EHR necessary to support accountable care goes far beyond a collection of criteria currently defined in statute.  The EHR used by the delivery system must also be capable of consuming and providing information to coordinate care across multiple sites, have registry functions to support population based preventive and diseased based care,  and include strong decision support engines that provide information in a timely, usable format.   They must be able to exchange information with patients, or possibly their remote monitoring devices.  They should have quality reporting capabilities that can be used by the clinician or to provide external reports.  In short, as ACOs take on many of the functions previously done by payers, the EHR systems must evolve to support these functions as well as those that directly support patients and caregivers.  First and foremost, they must be integrated systems with the capability of exchanging health information across the organization and its many boundaries.  EHRs in an ACO environment must be EHRs with health information exchange (HIE) capability….at least within the ACO structure.

As noted, clinical information must be combined with financial information to develop the analytical reports necessary for true business intelligence.   The usefulness of predictive modeling tools, all-payer data bases and case mix adjustment systems is dramatically increased when clinical and financial data are combined.  Before using these new HIT tools, however, the organization must have contract management systems, reimbursement systems, and revenue cycle management systems that can adapt to new and diverse payment methodologies, including those that are based on clinical outcomes.   Some of the mature organizations that have been functioning under risk for some time have developed their own HIT systems to perform these new financial risk management tasks, though the market is rapidly developing and introducing new products.

Lastly, HIT systems to support operations must be upgraded and integrated as well.  No longer is simple scheduling adequate.  A scheduling system must now follow up on missed appointments, missed procedures and more.  Registering patients, checking on eligibility for insurance coverage and charging the appropriate fee based on individual patient coverage must be a customer friendly, error free process in order to keep patients within the provider system.   Including patient-generated data further not only promotes this “stickiness” of patient to provider in an environment where the patient is free to choose a provider whenever they wish but also covers both operational and clinical functions.   Again, there must be integration between the clinical and administrative sides of the business.

Very few organizations will have the entire suite of HIT programs, services and products necessary to maximize revenue and provide the best of care when first committing to an ACO environment.   Each ACO will need to develop its own roadmap of what to add and when, based on its current set of HIT capabilities, what may be available through the payers with which it is working, and what other supports, such as HIE or data warehouses, that are available locally or regionally.   However the HIT infrastructure is built, attention must be paid to these three areas — clinical, financial, and operational — and to integration among all HIT systems.   This is a crucial first step in assuring the care that everyone looks forward to providing and receiving.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.

She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

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From the Chair: Meaningful Use, Round Two (Part 2): ONC’s Proposed Rule for Standards and Certification Criteria

by Karen Bell, MD, MMS on April 10, 2012

As noted in our March Letter (Part 1: CMS’s Proposed Rule on Stage Two Objectives and Measures) proposed rules for both Stage Two Meaningful Use objectives and measures and 2014 standards and certification criteria were published in the Federal Register in early March. Having reviewed the CMS proposal, we now turn to ONC’s proposal to certify technology in support of Meaningful Use. While individual criteria continued to match and support individual Meaningful Use measures, the program’s overall structure and focus, as proposed, changed significantly. The proposed program allows for greater flexibility in the technology necessary to support Meaningful Use, increased communication with patients, and major emphasis on unidirectional interoperability with reporting of data to public health, registries, patient controlled devices and CMS. The new standards and criteria, once final, will be referred to as the “2014 Edition” and technology certified to meet these standards and criteria may be used for either Stage One Meaningful Use attestation or Stage Two, but must be in place as of FY/CY 2014 for either stage. Currently ONC certified technology will also support Stage One attestation through FY/CY 2013.

Once the standards and criteria are finalized and published, by some estimates in September, ONC will need to publish testing procedures that must be followed when testing any of the Electronic Health Record (EHR) technologies used, so it is possible that 2014 Edition certified products won’t actually be on the market until the end of the this year. In the interim, expect a lot of public comment, especially on the following:

  1. A “bulls eye” approach to EHR technology includes a number of certified functions in a Base that every provider must have, a surrounding ring of additional “Core” functions that may be setting or stage specific, and a final ring of menu functions. This approach has the definite advantage of minimizing the need to purchase technology that would not be needed or used by the clinician or hospital. It could, however, increase the risk that various modules or functions do not integrate at the patient care level and increase the need for providers to understand exactly what they need and how best to purchase it — whether they have existing technology or are newly adopting. Robust public comment is anticipated on the criteria that would be included in the Base.
  2. Security has been scaled back to apply only to testing of the Base EHR and would no longer be applicable to products that support criteria in either of the two outer rings. As an example, a module that supports family health history that does not integrate with a base EHR would not be subject to any type of security testing under this proposed new rule.
  3. Only one clinical quality measure would need to be tested in order for the Clinical Quality Measure (CQM) module or criterion to pass certification. Most developers, however, are likely to bring the full set for certification, though the numbers have increased in both settings.
  4. Criteria that are tested together cannot be sold separately as “certified.” This is consistent with the current approach to certification. If all the certified functions in a Base EHR are certified as a unit, it must be sold as a unit. If the Base EHR meets certification by testing and certifying separate modules, the separate modules still constitute a Base, but each can be marketed and sold separately.
  5. Patient safety would be addressed by vendor attestation that specified User Centric Design (UCD) principles were followed in the development process. The specific UCD principles followed by the vendor would be published. The proposal is silent on what this means for provider self built systems.
  6. The proposed health IT standards will likely foster robust public comment, several of which have yet to mature to the level of specificity necessary for reliable health information exchange.
  7. There are also a number of questions where ONC specifically requested public comment, such as: certification of technology for non-incentivized providers, recording of disability status, data portability, and cost transparency of certified products. Public input on these will be important as well.

There is tremendous opportunity to shape public policy and how health IT is used in health care during the public comment period and we encourage everyone to do so. The 2014 criteria and standards are available at: http://www.gpo.gov/fdsys/pkg/FR-2012-03-07/pdf/2012-4430.pdf. Public comment deadline is May 7, 2012.

CCHIT is also planning to make public comment on ONC’s NPRM on standards and criteria. We will make those comments public at the close of the public comment period in early May.

In the interim, providers with existing EHR systems must wait until the rules becomes final, the new testing procedures are developed and piloted, and the new criteria and standards are incorporated in the current 2011 Edition of certified products. These upgrades will not be necessary until FY/CY 2014 for those who already have currently certified EHR technology.

Those who are considering purchase of a new system must decide if it is better to wait for products certified to the 2014 Edition or purchase now, knowing that upgrades will be necessary before the end of 2013. When considering the choice, remember that the process of choosing a product, preparing for the transition to EHR, actual implementation, and getting used to using a system takes time — at least a year in most circumstances. Start on those parts of the journey that you can traverse now with an eye toward implementation in early 2013 if you plan to attest to Meaningful Use in the 2014 timeframe…..and choose your ONC EHR certification edition accordingly.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.

She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

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From the Chair: Meaningful Use, Round Two (Part 1): CMS’s Proposed Rule on Stage Two Objectives and Measures

by Karen Bell, MD, MMS on March 21, 2012

Two Notices of Proposed Rule Making (NPRMs) from the US Department of Health and Human Services (HHS) appeared in the Federal Register early this month that are of particular interest to those in the delivery system and anyone in the world of health IT. The proposed rule for Stage Two Meaningful Use objectives and measures from the Centers for Medicare and Medicaid (CMS) was quickly followed by the proposed new 2014 standards and certification criteria for electronic health record (EHR) technology from the Office of the National Coordinator (ONC). Both describe how providers qualify for incentive payments. The proposed rules initially engendered considerable excitement, but interested parties have now moved on to the detailed work of thorough review, analysis, and public comment, due by May 7. CMS and ONC will then incorporate public commentary as appropriate and publish the final rules late summer – likely in September according to some estimates.

In the interim, physicians and other clinicians as well as hospitals are finding the proposed new rules to be complex, confusing and not necessarily consistent with their own timeframes for adopting ONC certified technology and meeting meaningful use goals. However, decisions about purchasing and implementing technology or what stage to attest to and when may need to be made well before the new technologies are ready and new reporting periods begin.

One of the salient points to be made about both proposed rules is that extensive public comment was requested, extensive public comment is expected, and it is possible that aspects of both rules could be scaled back. Since public comment is required when making these rules, the Federal government cannot add elements in a final rule that have not had public scrutiny. They can, and generally do, however, propose “stretch” goals — measures, requirements and criteria that might be modified, based on public comment. Therefore, much of the new material could undergo change — some of it significant — making it unwise to bet on any of it at this point.

CMS’s NPRM on Stage Two can be summarized as follows:

  1. Most of the changes from Stage One to Stage Two Meaningful use involve:
    • Increasing the percent threshold of an existing measure (e.g., from 50% to 80%)
    • Moving a measure from “menu” to “core (e.g., conduct medication reconciliation for transitions of care to an Emergency Department or a hospital to an eligible provider)
    • Extending current reporting requirements (e.g., require continuous reporting of public health indices rather than a single demonstrate that they can be done)
    • Requiring use of structured data to enter information that could have been entered as free text or other indication in Stage One

     
    With the exception of developing workflows for continuous reporting of public health data, these represent no or minor changes from Stage One. You could possibly see them in the final rule with little or no change from what was proposed.

  2.  

  3. Five of the new measures are in the menu set and include successful ongoing submission of cancer case information to a cancer registry and to a second specialized registry for eligible professionals; e-prescribing of discharge medications for hospitals; and access to images and structured data entry of family history information for both sets of providers.
     
    Successful ongoing submission of data to registries assumes that there will be registries which are programmed to accept these data, though they are not mentioned in the proposed rule. It also assumes supportive workflow for this process within the clinical setting. Public comment on these new menu measures could be pivotal.
  4.  

  5. As new core measures, hospitals would now use e-Medication Administration Record systems, patients of eligible professionals would use secure messaging, and both hospitals and clinicians would attest that more than 10% of their patients actually viewed, downloaded, and transmitted their health information electronically to a third party , such as a patient controlled health record or another provider. Lastly, 10% of transition of care summaries would be sent to unrelated EHRs outside of both provider types’ organizational affiliation.
     
    Expect significant comment on these new proposed core measures that depend on patients’ desire and ability to perform the defined task, some assurance that information transferred by a provider to a “third party” is to a secure environment, and probable disruption of established referral patterns either within or external to an accountable care environment.
  6.  

  7. Additional quality measures: 12 total for eligible providers (group reporting allowable) and 24 Continuous Quality Measures (CQMs) for hospitals (includes 15 from Stage One)
     
    Anticipate public comment on need to align measures across programs and need for development of robust and reliable e-measures.

 
ONC’s NPRM on Standards and Certification Criteria had far more modifications than the Meaningful Use NPRM. These will be reviewed in detail in Part 2, with the recognition that the final standards and certification rule must be aligned with the final rule for Stage Two Meaningful Use objectives and measures. Part 2 will appear in April’s edition of Letter from Chair. CCHIT is also planning to make public comment on ONC’s NPRM on standards and criteria. We will make those comments public at the close of the public comment period in early May. We encourage our readers to review these NPRMs and make their own comment. The Stage Two Meaningful Use objectives and measures. Public comment deadline is May 7, 2012.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.

She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

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Bloomberg BNA: Number of certified products likely to decrease over time

by CCHIT Staff on February 28, 2012

There are currently more than 1,700 EHR modules and complete EHR systems certified for both ambulatory and inpatient settings participating in the Medicare and Medicaid EHR incentive programs, according to ONC’s website.

With so many certified products, providers are overwhelmed and confused looking for products that meet their particular practice needs, best support patient care, and also garner incentive payments, experts said.

“We feel quite strongly that clinicians should know more about what technology they are purchasing,” said CCHIT Chairman Karen Bell.

As the Office of the National Coordinator for Health Information Technology’s EHR certification program moves forward in Stages 2 and 3 of meaningful use incentive program, EHR modules, systems, and other health information technologies will consolidate and give providers fewer choices for certified products, Harry Greenspun, senior advisor for health care transformation and technology at the Deloitte Center for Health Solutions in Washington, told Bloomberg BNA.

“I think we will continue to see consolidation of the market, … also consolidation more broadly in terms of physician practices, hospitals, and movement toward accountable care,” he said.

For more, visit Bloomberg BNA Health Law Resource Center.

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From the Chair: ARRA Anniversary

by Karen Bell, MD, MMS on February 11, 2012

This month marks the third anniversary of the passage of the American Recovery and Reinvestment Act (ARRA) with its embedded Health Information Technology for Economic and Clinical Health (HITECH) components. Since February 2009 we have seen remarkable progress in HIT program development at the federal level, including the dispersion of billions of dollars to help specified clinicians adopt and “meaningfully use” certified EHRs and help states develop approaches to sustainable HIE. We’ve also seen the formation of a federal advisory infrastructure that leverages the subject matter expertise and experience of a wide variety of stakeholders interested in using HIT for safer, more effective, efficient, and equitable patient-centered health care. We have definitely come a long way over the course of three years, but the opportunity to evaluate the impact of these efforts is just beginning.

The first publication of some significance became available in January 2012 — the list of products used by providers who have successfully attested to meaningful use of certified EHRs in the first year of the Medicare incentive program. Each month at the HIT Standards and the HIT Policy Committees, we learn the numbers of providers registered in both the Medicare and Medicaid meaningful use programs, as well as the numbers of providers that have received incentive payments. The latter numbers are still small (4.4% of all eligible clinicians) but it is likely that they will grow as more successful attesters receive their payments. While we know little about these successful attesters due to their relatively small numbers, we now know what technologies these clinicians are using. And it’s no surprise that the vast majority are using tried-and-true EHRs of multiple varieties — both server-based and web- based.

This finding may be related to the staggering number of choices on ONC’s Certified HIT Product List (CHPL), which currently includes more than 1,100 ambulatory products. Some are minor version changes of the same product and many are “modules” — technologies that meet one or more meaningful use criteria to complement other products that are not complete EHRs. Given its sheer volume, the list is overwhelming and confusing to clinicians looking for products that meet their particular practice needs, best support patient care, and also garner those incentive payments. The obvious fall back is for the clinician to choose what has been demonstrated to work in the clinical environment by others over the years.

The heavy dependence on the familiar names and products also could be because most of the attesters already had and were comfortably using EHRs before ARRA/HITECH was enacted. With an upgrade to assure that their EHRs could be certified for meaningful use and greater attention to measurement and reporting, these earlier adopters could be among the first to complete the application and attestation processes and see a check appear in the mail for these within a few months.

The most important reason for the reliance of these first attesters on well known systems, however, may very well be that these products are the ones that best meet clinicians’ need for information support as they care for their patients. It should be no surprise, then, that more than two-thirds (68%) of the complete EHRs listed are also CCHIT Certified®. These are the products that have been tested for integration of function, workflow, and state of the art security with the clinician and patient in mind — far beyond what ONC certification requires for Stage One meaningful use measurement. Since CCHIT does not have certification programs for many of the specialty EHRs listed — such as products used only by chiropractors, optometrists, or podiatrists — the reliance on dually certified products, CCHIT Certified ® and ONC Certified in the general medical community is even more striking. Most clinicians want the assurance that patient data will be backed up (not lost), that information is integrated within their system (instead of needing a degree in medical informatics or paying large sums to integrate disparate modules), that the systems have been demonstrated to work in an office environment similar to their own (with minimal risk of the vendor withdrawing from the market), and that the EHR has met at least a basic test for usability.

It’s also important to recognize that all of these attributes are basic patient safety features in an EHR system. There is no question that innovation is good for all concerned…even the best of EHRs today have their flaws. Innovation, however, carries varying degrees of risk. When that risk can lead to patient safety problems, clinicians tend to become relatively risk adverse and rely on what is familiar and proven to work. Does this mean we will be relying on the current EHR base in the future? Highly doubtful. We will eventually get to plug-and-play systems where a provider can choose among various medication management vendors, various vendors’ closed loop order entry systems, and various disease registry systems vendors that all integrate on a single platform. But that’s the future, and not within the time span of the current meaningful use incentive program. So, for now, look for more of the same — a heavy reliance on tried-and-true CCHIT Certified® EHRs that also are ONC Certified.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.

She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

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From the Chair: Patient Safety

by Karen Bell, MD, MMS on January 9, 2012

The recently released report by the Institute of Medicine concluded that protecting patient safety in a digital environment is multifactorial, encompassing technological functions, usability of the products, and implementation and use by providers and others.  Ten recommendations were made to establish the nature and extent of issues related to patient safety and health IT, how they could be monitored over time, and how they might be addressed by the public and private sectors.

One of the recommendations gave the Department of Health and Human Services 12 months to contribute to and assess progress in the public and private sectors towards these efforts, after which time the report recommended that the Secretary should make determination regarding the necessity for Food and Drug Administration regulation. If not necessary at that time, the Secretary should reassess this decision on an annual basis.

As these recommendations are considered and variously implemented the question remains on clinicians’ minds as to how they can assess whether or not their own electronic health record (EHR) supports safe care now to the greatest extent possible. While there is no one tool that can be applied to answer that question, there are practical approaches that could be used to assure that the most up-to-date functions and features are present.

A good place to start is malpractice claims.  52% of all paid medical malpractice claims in 2009 were in the ambulatory setting, with two thirds of these involving major injury or death. A recent analysis suggests that most adverse judgments fall into three categories: poor communication, poor documentation, and problems associated with diagnosis and treatment of a patient. It’s worth considering how health IT can better address these issues, and the degree to which they can currently be assessed to do so.

Communication gaps can occur within a practice, among clinicians in different locations, and between clinicians and patients. Does your system allow secure messaging with patients; does it have a patient portal through which you can communicate with your patients? Can you generate and record patient specific instructions as well as educational materials. Does your EHR support concurrent use by multiple staff and can you access, create, and allow modification of jointly managed care plans? What about clinical task assignments and routing, and the ability to co-sign notes? Are verbal, telephone, and electronic messages between users documented, along with discrete data on specified roles of each provider associated with a single patient? Recognizing that interoperability with external provider systems is beyond the scope of a single EHR, do you at least have a directory of external providers and can you capture external documents?

Documentation is the second major area to consider. Does your system support efficient but reliable documentation of your findings and results? Can you incorporate free text? Do your checklists and templates appropriately default to normal findings only when you have actually examined the patient and recorded your positive findings, including those areas not examined? Can you make modifications and corrections? Are consents and authorizations clear and easily retrieved?  How easily and accurately can you manage problem lists, medication lists, and allergy and adverse reaction list as well as clinical documents and notes? As alerts and reminders are brought to your attention, is there some way to document why you may or may not choose to act on them? Lastly, check for back up.  A system that can lose patient data is one with a built in patient safety risk.

Diagnosis and treatment risks can be mitigated to a large extent by good e-prescribing, medication management, and medication reconciliation functions. Alerts should optimally include drug/drug, drug/allergy, drug/diagnoses, and some form of drug/lab information, but should be meaningful to the individual clinician using the system to avoid alert fatigue.  Another area where an EHR can help mitigate patient safety risk is closed loop ordering. This means that the clinician should at least be able to view active orders for a patient, display outstanding orders for multiple patients, see the status of orders, receive notification when new results are received, and link results to the original order. It also means that the clinician is notified when a test result is not returned, or a prescription has not been filled, though few systems function at that level now.  Ways of assuring that patients receive appropriate testing for disease management, medication management, and preventive services should include both reminders inserted into clinical workflows and automatic reminders to patients or their guardians.  The last, and arguably the most important areas in support of appropriate diagnosis and treatment are data integration and presentation. Are you informed whenever new data points enter your patients’ records? Can you easily eliminate or modify duplicative or erroneous data points?  How well does your system aggregate data and present them in usable formats so that you are truly knowledgeable about your patients’ history and progress?

All three areas interdigitate. Good communication requires good documentation requires good data management requires good communication. As CCHIT certification has matured over the years, attention has been paid in all three areas with the recognition that integration of all functions is the foundation on which all other patient safety functions rest. Testing for integration using clinical workflows that support many of the patient safety functions listed here is unique to CCHIT Certified® products, and is not present in ONC certification, as many of the functions are not. As we look to the future, CCHIT will increase its focus on assuring that patient and provider needs for safer, more usable systems are met.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.

She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

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Bobbie Byrne, VP/CIO, Edward Hospital, chats with HIStalk about CCHIT

by CCHIT Staff on January 4, 2012

HIStalk recently interviewed Bobbie Byrne, VP/CIO, Edward Hospital. Here’s what she had to say about her efforts with CCHIT:

If you think about certification, I’ll divide into two phases. One is the formation of CCHIT, which was to help increase adoption of health information technology by removing some of the risk on the buying side, and that CCHIT certification really meant something and that when if you were buying a CCHIT-certified product, it wasn’t going to be perfect, but you could be assured it was going to have some baseline interoperability security and functionality.

I do think that that changed very much the way that people purchased systems. For example, the days of the scripted demos to make sure that you could do long lists of specific feature-function .. those days are gone, and mostly because if it’s a CCHIT-certified product, you can already pull out the long list of feature-function, security, interoperability items that you know the product can do. I really believe very strongly in CCHIT moving the market forward.

Read more of the interview. Or for more insights from Dr. Byrne, visit her blog.

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From the Chair: Care Coordination and the Office-based EHR

by Karen Bell, MD, MMS on October 27, 2011

We continue to hear more and more about organizing the delivery system around “Accountable Care Organizations” that aim to coordinate care across multiple sites of care.   Major strides are currently being made in development and implementation of interoperability standards which will support transport of information among providers’ electronic health records (EHRs).  Health Information Exchange Organizations all over the country are preparing to support exchange of hospital discharge summaries and clinical care summaries.

This type of information sharing among various types of providers using disparate EHRs is critical for true care coordination.   Also important, however, is the degree to which clinicians and EHRs in the ambulatory setting are prepared to actively provide more comprehensive integrated care as more robust data become available.   There are a number of basic functions that are common to most EHRs (i.e., recording patient demographics, drug/drug alerts, reminders, report generation, etc.).   There are also a number of integrated EHR functions that are key to the support of care coordination by practices.

Support team-based care

As you reassess your current EHR or look to a new one, there are a number of care coordination functions you should look for.  A good starting point would be to support team-based care through EHR use of:

  • Intra-practice communications  through messaging, inclusion of verbal orders, and recording of telephone conversations
  • Concurrent use of your EHR by multiple authorized individuals while maintaining information integrity when accessing care plans, guidelines, and protocols
  • Clinical task assignment and routing
  • Management of clinical documents and notes to include co-signers, corrections, support for both  notes in progress and  final notes, patient annotations, and free text in addition to structured data

Organize and assess

Once you have built an effective team with clear job descriptions and efficient workflows, and you have trained them well to use these enabling functions, you will want to assure that you have an EHR with the functionality necessary to organize and assess your electronic patient health information.   Some of the more important areas that you should look for are:

  • Managing coded problem lists to include not just diagnoses, but dates of onset, resolution, chronicity, updates, linkage to orders, addition of free text, and different ways of viewing
  • Managing medication lists to include ordering clinician, changes (when and who made them) explanatory free text, medication history, over the counter preparations, or  no medications when that  is the case
  • Managing results — in addition to many of the steps noted above, you will want your EHR to be able to display results graphically and on flow sheets, be notified of new results, and forward results to others with notes and annotations
  • Managing a patient history by including documents from external sources, recording both negative and positive findings, and updating clinical, family, and social histories

Consider patient engagement

Care coordination without patient engagement is an oxymoron.   You will want to know your EHR system at least supports:

  • Generating and providing patient specific instructions through links to other sites or from embedded functionality
  • Managing  consents and authorizations with the ability to print, sign, and store and possibly allow for electronic patient signature
  • Managing  advanced directives by at least noting the type, that you’ve reviewed them with the patient, and where they might be found or who should be contacted as a health care proxy
  • Identifying  all clinicians engaged in a specific encounter and the primary provider of care
  • Scheduling of appointments and follow-ups, and the ability to view whether or not they were kept

If your system provides a patient portal or secure messaging with a patient, consider this an added but important bonus.

Incorporate data electronically

Lastly, until your capacity to incorporate data electronically from other sources expands, you will want your EHR to support some way of

  • Capturing, storing, and indexing external clinical documents
  • E-prescribing and communicating with pharmacies about medication requiring prior authorization or other administrative processes

Conclusion

In summary, you can review your EHR and processes now to assure that you are coordinating care for your patients using the information you currently have.   When access to more comprehensive patient data from outside of your office setting or healthcare system becomes available, they can be incorporated into the record and be included in your approach to the coordinated care that you already have in place.

Many of these desirable functions are already included in EHRs tested by our CCHIT Certified® 2011 program. This independently developed CCHIT certification program includes a more rigorous inspection of integrated EHR functionality than the Office of the National Coordinator (ONC) authorized program which is designed only to meet minimum government requirements qualifying providers for meaningful use incentives. Future CCHIT Certified development will continue to consider the evolving care coordination needs of office-based practices.

Karen M. Bell, MD, MMS
Chair, Certification Commission

Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.

Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.

She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.

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