Thousands of eligible professionals and hospitals will have to meet Stage 2 requirements for the Electronic Health Record (EHR) Incentive Program (“Meaningful Use”) in the coming year. Some hospitals may seek to attest to Stage 2 objectives as soon as 12 months from now. For healthcare providers, failure to achieve objectives can put thousands or millions of dollars of incentive payments at risk. Will health departments be ready to meet them half way in information exchange? The answer depends on whether they are preparing now. Absent a strong project plan in the next few months, the answer may be “no”.
Here is a checklist for health departments to consider:
1. Are you prepared for MORE DATA? The standard for Stage 2 rises to on-going data submission, rather than just sending a test message. Are you ready to receive, parse and use steady streams of data from many healthcare providers? Health departments can still manage the pace of on-boarding new providers, but must do so in a way that does not put providers at risk (see points 6 and 7).
2. Are you ready to accept MORE TYPES of reporting from each provider? In Stage 1 providers could select only one of several “menu” public health objectives. Some menu options in Stage 1 are now required (“core”) in Stage 2. For example, hospitals must submit ALL OF immunization data, electronic laboratory reporting and syndromic surveillance reports to health departments ready to accept them. Eligible professionals must submit immunization data AND select from other menu objectives (including several public health options) to obtain their incentive.
3. Are you prepared to use HL7v2.5.1 messages for immunizations and syndromic surveillance? Two standards to choose from in Stage 1 created confusion and frustration, so there is only one standard for each Stage 2 objective. However…
4. Are you willing to GRANDFATHER providers that have achieved on-going submission of HL7v2.3.1 messages in Stage 1? This option is up to the health department, and can help you avoid having to re-on-board those providers already successfully submitting data using HL7v2.3.1. Any new data providers must use v2.5.1 however.
5. Will you accept CANCER REGISTRY data documents using the Clinical Document Architecture standard specified in Stage 2? Do you intend to sponsor any other SPECIALIZED REGISTRIES in 2014? These are new “menu” options for Eligible Professionals.
6. Do you have a plan to publicly DECLARE READINESS of what public health reporting objectives you will offer for Eligible Professionals and Eligible Hospitals during each reporting period? Because providers need timely and definitive information, Stage 2 rules now allow providers to claim EXEMPTION from public health meaningful use objectives if such a declaration is not publicly available for their jurisdiction. (Public health departments need not receive data for any or all objectives, but if they wish providers to be motivated by Meaningful Use incentives to submit data, they must publicly state in advance of each reporting period which objectives will be accepted.) A closely related issue: if more than one jurisdiction in a state receives Meaningful Use data submission (for example, if there are both local and state level syndromic surveillance or immunization information systems) are state and local departments planning to COMMUNICATE CLEARLY which exchange opportunities and requirements apply to which jurisdictions?
7. How will you manage Eligible Professionals and Eligible Hospitals that intend to initiate data submission during each reporting period? Stage 2 rules require providers to REGISTER their intent to submit data with the appropriate health department. The health department need not then immediately on-board the provider, but has the option to later disqualify a registered provider from receiving incentives if it fails to respond within 30 days to two written requests to take action (i.e., to begin sending test data, or to adjust transmission, structure or vocabulary to the required standards).
8. Do you intend to DESIGNATE a Health Information Exchange to receive some public health data submissions? To ensure good end-to-end transmission of reports, HIEs cannot claim to substitute for health departments unless they are designated to do so.
9. Is there CLOSE COORDINATION and a RESPONSIBLE OVERALL MANAGER linking planning with each of the affected surveillance programs (and jurisdictions), the state HIT coordinator, Medicaid director and HIT Extension Center?
[And 10. for health departments using EHRs and enrolled in the EHR Incentive Program: Will my EHR migrate to 2014 edition certification standards, and can we meet Stage 2 objectives to earn our incentive?]
Obviously, serious planning is needed. Some health departments may be asking: is all this worth the effort? It is critical to remember that:
1. Meaningful use is establishing the de facto standards that will be used for information exchange in the future. The faster health departments adopt the new national standards and on-board data submitters, the faster they can be automating data management and the detection and management of critical events. This can serve both effectiveness AND efficiency. National data and exchange standards will foster the ability of vendors and development of systems to aid health departments with these tasks.
2. Before long, most providers will have electronic health records that are all certified to capture and transmit information in standardized ways. Onerous reporting processes for providers, and incomplete reporting to health departments, can both be addressed to the benefit of both through automation.
3. Health departments can decide the pace at which they enroll providers in Meaningful-Use-specified data exchange. Health department participation is optional, but Meaningful Use incentives (and later, penalties) will induce providers to begin submission whenever the health department is ready. What the new Stage 2 rules demand in return is that health departments communicate clear plans and requirements to providers. It is the latter who then face financial loss if objectives aren’t met.
4. The new rules continue to support the idea of “queuing providers” and on-boarding them at the pace the health department can tolerate. Once providers are registered, they are not at risk of losing their incentive UNLESS they fail to respond timely (30 days) to requests from the health department. The health department can invite registered providers to initiate data exchange at whatever pace is practical, and neither party “gets hurt.”
5. Stage 3 will likely move beyond surveillance to improving preventive care delivery. For example, immunization information systems (which by Stage 3 will be bulging with information submitted by hundreds of thousands of healthcare providers) will likely be able to alert professions to immunizations patients lack, using the EHR during the context of care.
It may be a tough slog now, but there’s much to gain at the far end!
Fortunately, a Stage 2 Task Force of affected public health associations has formed under the leadership of the Joint Public Health Informatics Task Force, the Centers for Disease Control and Prevention (CDC), and the Office of the National Coordinator for Health Information Technology (ONC). It will soon be issuing fact sheets and other tools, which will likely be distributed at the NACCHO ePublic Health Blog among other modalities.
NPR’s All Things Considered yesterday described “growing pains” in health information technology (HIT) by saying many doctors in Colorado had to enter immunization records twice: first into their Electronic Health Record (EHR) system, and then into the state’s immunization registry. According to the story, many doctors fail to do both
In fact, immunization registries, the Centers for Disease Control and Prevention, the HHS Office of the National Coordinator for HIT, and the Centers for Medicare and Medicaid Services (CMS) have worked together to implement solutions for this problem.* The federal EHR Incentive Program (better known as “Meaningful Use”) includes an objective for EHR systems to upload shot records into immunization registries, eliminating the “double entry” problem. The Colorado registry has implemented the necessary standards, and instructions for doing so are published on the same website cited in the NPR story.
This process is still not simple. But the needed standardization is further improved in Stage 2 of Meaningful Use, scheduled to begin in October 2013. And in October 2015 federally-certified EHRs could be required to download immunization records and alerts for clinicians about which vaccines a patient lacks. Such automated data and reminders are needed to accelerate the completeness of childhood immunization which remains subpar.
I appreciate NPR’s attention to this challenging issue. But while various difficulties affect the transition to electronic health records, NPR inadvertently selected a success story to illustrate the problems.
*Full disclosure: I was among those involved in this collaboration.
The clock is running for public health advocates to advise what should be included in Stage 3 of the Electronic Health Records (EHR) Incentive Program (“Meaningful Use” (MUse)).
January 14, 2013 is the deadline for comment on the Health IT Policy Committee’s recommendations for Stage 3.
- A key issue is whether EHRs should be certified in Stage 3 to generate electronic public health reports using a new, standardized approach. The Public Health Reporting Initiative is finalizing both a harmonized data element profile and a Clinical Document Architecture implementation guide in the next few weeks.* These are based largely on the Cancer Registry reporting standard that appears in Stage 2 MUse rules and on implementations already in place for the National Healthcare Safety Network (NHSN) and recommended for Stage 3. Adopting the PHRI approach need not require change to existing MUse reporting activities like electronic laboratory reporting, immunization registries or syndromic surveillance. However, it provides a reusable, modular, and extensible methodology that could be leveraged by these and many other types of reporting (for example, communicable disease case reports, product safety reports, birth and death reports) into the future.
- The public health (and health IT) communities should examine the PHRI documents to decide if they represent an achievable step toward more generic interoperability between EHR and public health surveillance systems. If so, they will have to make their voices heard during the comment period, because MUse Stage 3 certification is NOT recommended by the HIT Policy Committee (rather, it is recommended for some future, unspecified time).
- The Centers for Disease Control and Prevention (CDC), which funds much US public health surveillance, needs to decide and announce whether it will support pilot implementations, full-scale implementation, and health department migration to the new approach going forward.
- The Office of the National Coordinator and CDC need to ensure that PHRI products are harmonized with similar initiatives across the ONC Standards and Interoperability Framework, and curated and maintained over time.
- Other important issues in the Stage 3 recommendations include EHR data capture of information like occupation and disability; whether NHSN hospital reporting should be included as a new objective; and whether additional public health registries should be offered as choices in the incentive program.
Early in the Wisconsin Health Information Exchange (WHIE) we realized a high likelihood of finding information for a local provider or patient was key to a successful business case. (Techies call this “network dependency.”) So I wasn’t surprised November 28 to hear market share penetration labeled the single item that best distinguishes sustainable from struggling HIEs by the HIE Learning Network of the National eHealth Collaborative (NeHC). What is surprising is that HIE policy often disregards this vital factor.
At Technology Crossroads, Jeffrey Rose (ICG Group) and Delaware Health Information Network (DHIN) CFO Michael Sims presented factors identified by the Learning Network that distinguish profitable from unprofitable HIEs. (Other factors in addition to high market share penetration are aggressive pricing and investment in product development.) DHIN is verging on both 95% market penetration and long-term black-ink performance. (For more on this and other Learning Network lessons, join the December 17 NeHC University webcast.)* [Update: Dec 18: the Learning Network report has been published.]
Meanwhile, many HIEs around the country are struggling. The eHealth Initiative’s 2012 HIE survey lists sustainability as the top obstacle, and found that over half are encountering competition from other HIEs. They are also competing with HIT vendors providing exchange technologies directly to provider networks.
For example, the November 21 IHealthBeat reprinted a story from the Oct. 18 Tampa Tribune detailing how a public HIE serving hospitals is competing with a private HIE serving physicians. Meanwhile, in several states, new HIE entities created by the Office of the National Coordinator (ONC) State HIE grant program compete with pre-existing regional efforts. (Most early regional HIEs focused on medical marketplaces defined by referral patterns, not state lines.) Adding to the confusion are statements from ONC leaders that put exchanges developed inside Accountable Care Organizations (ACOs) on the same footing as regional “all-provider” HIEs. This fails to acknowledge that such private entities may aggressively compete, including taking information hostage. A recent New York Times story details how increasing provider consolidation (neither citing ACOs nor excluding them) can block clinical communication with competing providers.
Perhaps, at least initially, competition is toxic for successful health information exchange. In a 2007 eHealth Initiative report on HIE sustainability, we described social capital (resilient relationships among HIE stakeholders) as a key element for success.
An alternate scenario is that each electronic health record system will contain its own exchange capabilities (like the Direct “push” standard). But this model still works best with a “central switchboard” managing directories, authentication, record locators, and other services that an HIE can provide.
It seems that HIE resembles mail service, electrification, telephony, highways and fire services, possibly requiring a period as publicly-regulated, public service monopolies. Once the infrastructure is well established, competition can be introduced to accelerate innovation and price competition. Today, however, regional HIEs are competing with Federally-funded state HIE designated entities, which are competing with for-profits and ACOs. Meanwhile, market share is elusive, and network dependency can kill.
*Disclosure: I am currently on the NeHC University Advisory Board and a former NeHC board member.
While healthcare providers and public health departments continue to study how Stage 2 of the Electronic Health Record (EHR) Incentive Program, or “Meaningful Use,” will affect them beginning October 2013, the Health Information Technology Policy Committee has issued a Request for Comment (RFC) on proposals for Stage 3 and beyond that may shape the program after October 2015. Comments are due January 14, 2013. At least some of these proposals, shaped by comment, will re-appear in a Notice of Proposed Rule Making (and yet another round of public comment) next year.
The RFC unexpectedly pushed back a proposal for electronic case reporting of reportable conditions to an indefinite time AFTER Stage 3 (see below). Because the two Population and Public Health objectives targeted “after Stage 3” have been to focus of rapid and intensive work in the Public Health Reporting Initiative, they will likely merit further discussion as to timing.
Some items of public health interest for Stage 3 (by my own arbitrary criteria–you should read the RFC!) include:
- Adding the capability to record occupation & industry codes, sexual orientation and gender identity (optional fields) and disability status to EHR certification requirements (while not setting goals for provider capture of these elements)
- Using vital signs and lab results to support up-to-date problem lists (e.g., to use vital signs to signal potential hypertension on the problem list)
- RETIRING requirements to capture blood pressure, BMI and smoking status because recording is already at high levels (<80%, data source unstated). Progress will be tracked through hypertension and tobacco use quality measures instead.
- Increasing clinical decision support interventions from 5 to 15, including preventive services and chronic disease management, especially hypertension control and dosing of drugs for renal impairments.
- Change recording family history to recording high priority (unspecified) family history
- Educational materials made available in at least one non-English language based on which of the top-five non-English languages in US are spoken locally
- Transitions-of-care now specifically include referrals. Care summaries should include the identity of care team members like care coordinators, and EHR certification includes the ability to populate a referral form for specific referrals including smoking quit-lines.
- Notifying care coordinators (when appropriate) of significant healthcare events like emergency department visits or hospital admission or discharge.
- EHR importation and use of structured historical immunization data from immunization information systems (registries), and to receive, generate or access age-, gender-, and immunization-history-based immunization recommendations. The EHR certification criteria would requires the EHR to use standard rule sets and patient data to recommend immunization.
- Continuation without change to electronic laboratory reporting and syndromic surveillance reporting.
- Adding other mandated jurisdictional registries beyond cancer registries for which Eligible Professionals (and now Hospitals) may perform successful ongoing data submission to achieve a menu (optional) objective. In other words, cancer registries could be replaced by other registries in the menu objective for Eligible Professionals (and Eligible Hospitals would be offered a menu option for registry reporting for the first time).
- Adding a second menu option for standardized reporting to a second registry, which could include those from professional societies, public health jurisdictions or other aggregators (e.g. Accountable Care Organizations). It is a new requirement that such reporting use a national standard (“e.g., consolidated CDA”).
- Sending healthcare associated infection reports to the National Healthcare Safety Network (at least 10% of all reports sent from the certified EHR)
Two items of interest are pegged for “future stages” (i.e., after Stage 3). While it seems likely that HHS will continue to add future objectives and repairs to the program, the timing and nature of such activity is currently undefined.
- EHRs should determine when a case report of a reportable condition need be sent to a public health agency, and should send at least 10% of initial case reports electronically. [“Case report” means clinical information on a case for which a laboratory report of a reportable condition may or may not have been sent separately. NOTE that in earlier discussions by the HIT Policy Committee this objective was slated for Stage 3.]
- Reporting of adverse event (related to, e.g., vaccines, devices, EHRs, drugs or biologics) reports to FDA and/or CDC.
Dr. Thomas Frieden, Director of the Centers for Disease Control, can see satisfaction of his request that Stage 3 tackle improved clinical hypertension control, support for tobacco quit line referrals, and bidirectional communication with immunization information systems. Other voices, inside and outside CDC, have had additional goals, and many of these are reflected as well. Some of the key questions the public health (and larger Health IT) community must answer:
- Should at least some form of public health case reporting be pushed forward into Stage 3? Will the necessary message or document standard be ready in time, AND will a meaningful number of health departments be ready to receive it? [Look for a post on this topic shortly.] Is it necessary to have a national public health knowledge system that provides rules for public health reporting, or could jurisdictional requirements be manually programmed into EHRs? And who will drive to these answers and assure needed tools are created? [Disclosure: I served as a co-chair of the Public Health Reporting Initiative for a year until September, 2012.]
- Should cancer registries be demoted to just “one of” a variety of public health disease registries?
- If a standard format is created to report to disease registries, will public health (and non-public health) registries be able to convert in time?
- Will state health departments have adapted to receiving and managing CDA documents for Cancer Registries in Stage 2, and can they apply this to other use cases (possibly case reporting or additional disease registries) for Stage 3?
- And the perennial question: will health departments be drowning in data from Stage 2, or will they successfully harness the many new ongoing data streams into more effective and efficient case management and health surveillance systems?
Hard on the heels of my own departure from the US Centers for Disease Control and Prevention (CDC) on September 30 comes a clean sweep of high-level informatics leaders in the organization. Sources now confirm that James Buehler, MD the current Director of the Public Health Surveillance and Informatics Program Office (PHSIPO) will depart before year’s end. His supervisor, PHS Rear Admiral (ret.) Steven Thacker, a long-time advocate for cross-cutting integration, is also slated to leave his post as Director of the Office for Surveillance, Epidemiology and Laboratory Services (OSELS). These departures follow at least three years of marked funding reductions at CDC’s informatics core.
[Update 12/11/12: We’ve learned Dr. Buehler is departing for family reasons, and Dr. Thacker for health reasons. Friends and colleagues of Dr. Thacker can connect with him and his family here.]
Few signals indicate the future direction for informatics at the Agency. Acting leadership for OSELS will be placed in the hands of Denise Cardo, MD, director of the Division of Healthcare Quality Promotion, and Dan Jernigan MD, MPH of the National Center for Immunization and Respiratory Diseases (NCIRD) as her deputy. While Buehler and I were recruited from outside CDC, both of the new OSELS leads come from powerful National Centers in CDC’s Office of Infectious Disease. This may (but also may not) indicate a plan to redistribute the OSELS portfolio across the National Centers (sometimes called “Silos of Excellence”).
The timing for an apparent leadership vacuum and dwindling resources could not be worse. It comes in the middle of a massive one-time Federal investment of tens of billions of dollars in healthcare information technology and exchange. Standardization engendered by the “Meaningful Use” electronic health record incentive program could enable major progress in public health programs if two conditions are met. First, cash-strapped local and state public health agencies must make it a priority to migrate to new, more uniform standards and must have the resources to do so. Second, critical public health requirements for information exchange must be successfully negotiated with cost-averse healthcare providers and their information system vendors. Neither can be accomplished without dedicated leadership and resources. The need for a confident, skillful, flexible and funded approach to public health information exchange with healthcare providers has never been greater. We anxiously await the announcement of both new a new informatics vision and stable leadership at CDC.
I recently attended the 25th anniversary celebration for the Mectizan (ivermectin) Donation Program (http://www.mectizan.org/). Today the program is closing in on eliminating onchocerciasis, or river blindness, in several nations. President Jimmy Carter, former Merck CEO Roy Vagelos and former CDC director and Task Force for Global Health founder Bill Foege took the stage to recall how the program was born and succeeded out of a combination of luck and determination. Each admitted having no clear idea about how to realize the program at first, and each offered grains of wisdom learned since.
Dr. Vagelos recalled that the decision to give Mectizan away, as much and for as long as needed to combat onchocerciasis, was made for lack of an ethical alternative, though several were explored. Unexpectedly rapid regulatory approval and high expectations forced the executive decision even before the Merck board could be consulted. The decision had an unexpected long-term impact. Chemists, doctors, even factory workers flocked to Merck to work for the company with a clear moral compass. Merck did well by doing right.
President Carter said the program illustrates the oft-overlooked power of volunteers. The distribution of Mectizan is powered by local volunteers worldwide, including Lions Clubs who mobilize a small army of local business and community leaders in most nations touched by the disease.
Dr. Foege suggested that this program’s success, in contrast to many other public health campaigns, illustrates Sutton’s lesser known second law: “I get more done with a gentle voice and a revolver than with a gentle voice alone.”(1) An effective tool made the difference. “After people took Mectizan, some had the first itch-free day that they could ever remember,” Foege said. This rapid, obvious improvement in quality of life for some helped sell the drug’s benefits to all.
These lessons should give heart to informaticians who are rapidly prototyping, piloting and iterating real tools in the field, and those using volunteers (such as in open source development) to shape the work collectively. An application that “scratches the itch,” brings rapid uptake and success. Vaporous promises and endless planning likely have the opposite effect. We must not underestimate the power of the “revolver” in the hand over well-intentioned talk, nor the power of volunteers motivated by their communities’ needs.
Notes: (1) Paraphrased. I could not find attribution of this remark to Mr. Sutton, though he is quoted “You can’t rob a bank on charm and personality,” which carries the same message!
Pictured in the photograph L to R: Dr. William Foege, Dr. Roy Vagelos, President Jimmy Carter, moderator and Task Force for Global Health President/CEO Mark Rosenberg.
Additional information on the 25th anniversary event available at http://www.mectizan.org/news/mectizan-donation-program-celebrates-25-years-of-partnership-and-progress .
Keywords: public health informatics, Seth Foldy, health informatics, open source, Jimmy Carter, William Foege, Roy Vangelos