The ONC Interoperability Vision: An Opinion

The Office of the National Coordinator for Health Information Technology recently issued a “10-year vision” paper on interoperability in the HIT infrastructure[1]. The 10 years are broken up into three different time periods:

•        3-year agenda: Send receive, find & use health information to improve health care quality 

This set of goals is the primary interoperability functionality proposed by the ONC & is focused around the development of “an interoperability roadmap as articulated in HHS Principles and Strategy for Accelerating Health Information Exchange”[2]. This second document emphasizes several tactics for accelerating the use of HIE including: use of DIRECT & development of appropriate Stage 2 & Stage 3 Meaningful Use criteria, developing certification for HIE interoperability & a focus on security & privacy. This is all very well, but there are a number of issues I’d like to point out. First, the emphasis appears to be providing “interoperability” through HIE. the fact is that HIEs are having a hard time developing sustainable business models (regulatory compliance for interoperability is probably not a sustainable model, especially with no Federal money available for it),  & most of them are having trouble exchanging anything but the simplest data. Interoperability is usually provided through standardization of APIs (or other exchange mechanisms) across application boundaries. How does HIE-based interoperability work where healthcare organizations do not participate in an HIE & their EHRs are not interoperable? It seems that broader approach may be necessary.

Second, my personal experience with this approach to interoperability spans about 25 years of system development & includes participation in many standards efforts. Perhaps my most telling experience of defining standards-based interoperability came when I was Digital Equipment’s representative to the OMG effort to define interoperability among (CORBA-based) object systems. The representative from Sun Microsystem, with whom I had been arguing for about 3 months, finally proposed that interoperability would be served if my system sent his system a message & his system sent my system back an error message. This is where I feel we currently are with healthcare information interoperability.

As an example, a paper recently published (3 July 2014) in the Journal of the American Medical Informatics Association[3] looked at interoperability of Stage 2 Meaningful Use certified EHRs as the ability to exchange C-CDA documents (a Stage 2 requirement). In 91 cases, a total of 615 mistakes were found, many of which would have affected the quality of care. These included: incorrect name of medication, incorrect dosage amounts, incorrect dosage units, & incomplete references to narrative text, among others.

Finally, what about improving health care quality. The ONC’s document states: “we will work with federal and state entities to advance payment, policy, and programmatic levers that encourage use of this information in a manner that supports care delivery reform, improves quality, and lowers costs.” This seems appropriately ambiguous & difficult given the current policy & political environment.

•         6-year agenda: Use information to improve health care quality & lower cost

The ONC’s description of this time period describes a large variety of data aggregations becoming available for use by individual providers & healthcare organizations to use analytics to improve quality & lower cost. I think that this is part of the solution for these goals, an important part, but there are other uses of this data than developing new quality measurements & payment models, as important as these might be. This past April, I wrote a post entitled Re-engineering Healthcare: The View from Other Industries (4 April 2014, http://posttechnical.blogspot.com/2014/04/reengineering-healthcare-view-from.html). In this post I emphasized that industries such as Auto Manufacturing, Aerospace & Information had used multisource data aggregations as part of a re-engineering effort that focused on the redesign of workflows & work processes & the more efficient & effective use of R&D resources. This work has yet to be done in any realistic way in healthcare (other the workflow redesign necessary for EHR use, & it’s not clear how efficient & effective that is with respect to outcome improvement or cost reduction), & it will have to be done if quality & cost goals are to be met.

•         10-year agenda: The learning health system.

The ONC states that: “The evolution of standards, policies, and data infrastructure over the next 10 years will enable more standardized data collection, sharing, and aggregation for patient-centered outcomes research. Continuous learning and improvement will be feasible through analysis of aggregated data from a variety of sources.” This is a topic for another post. I spent about ten years working on issues of advanced reasoning & problem solving at Stanford & The Digital Equipment Corporation[4] & I’ll write (real soon now) on what I think a learning healthcare system would be like.

The ONC’s tactics for achieving this vision consists of five building blocks:

1.      Definition of core technical standards & functions
2.      Certification to support adoption & optimization of HIT products & services
3.      Privacy & security protections for health information
4.      Developing a supportive business, clinical, cultural & regulatory environment
5.      Rules of engagement & governance of HIE

Of these tactics, the first, second & fifth are (IMHO) complicated but feasible to achieve. The question is (as evidenced by the D’Amore paper & lots of HIE data), will the development of standards, certification & ROE for HIE actually improve interoperability. The answer is yes, over time – it’s the time element that’s the problem. 2-3 years of development & acclimatization would be annoying, but acceptable (maybe even optimistic). 5-8 years would mean that this approach would not be successful.

Tactic 3, privacy & security concerns are appropriate & inevitable. Balancing these concerns with the need for shared healthcare data for treatment, operational & research purposes has proven difficult & I don’t expect it will get easier as these regulations evolve in the next 2-5 years. One thing about this area is that people’s expectations are being set (& their resistance to various commercial & government tactics) by current practice including the NSA surveillance efforts, security & privacy concerns with current social media like Facebook, etc. & new interaction models on the web such as Snapchat. People are very aware of these issues, but developing healthcare systems that have appropriate function in these areas will take time (3-5 years)

Finally, Tactic 4 – working toward supportive environments… Listing all of the issues involved in this tactic would take pages & pages. Suffice to say that this will never be fully aligned with the ONC’s goals (again IMHO), but over time the edges will get chipped off so that interoperability may be possible.

Time seems to be the common theme here. I expect it will take 3-5 years of real effort to get to the point where these tactics bear fruit. The real question is in this political & cultural environment, do we have 3-5 years to evolve to an interoperable, more cost efficient & clinically effective healthcare system.

Next – What could a “learning healthcare system” look like? & a post on the tension between privacy & usage in healthcare systems

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[1] Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure. ONC. June 2014. http://healthit.gov/sites/default/files/ONC10yearInteroperabilityConceptPaper.pdf, accessed 25 June 2014.

[2] http://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf, accessed 25 June 2014

[3] D’Amore, J.D. et al. 2014. Are Meaningful Use Stage 2 certified EHRs ready for

interoperability? Findings from the SMART C-CDA Collaborative. JAMIA. Published online: 0:1–9. doi:10.1136/amiajnl-2014-002883. Accessed 25 July 2014.

[4] c.f. Hartzband, D.J., L. Holly, and F.J. Maryanski. 1987. The provision of induction in data-model systems: I. Analogy. International Journal of Approximate Reasoning (IJAR) 1(1):1-17. &

Hartzband, D.J. 1987a. The provision of inductive problem solving and (some) analogic learning in model-based systems. Group for Artificial Intelligence and Learning (GRAIL), Knowledge Systems Laboratory. Stanford University. Stanford, CA, USA. 6/87.

Progress in Healthcare Reform - Part 3:HIE & ACO

My last two posts addressed progress in healthcare reform from the standpoint of meaningful use & PCMH. In part, I tried to critique some of the recent criticisms of these programs, but in truth, I agree with some of that criticism & laid out why. This is the last post in this series (but certainly not the last post on progress in healthcare reform), & its focus is HIEs & ACOs. The issues with HIEs were covered in a late January (2014) Black Book survey[1] reported in Government Health IT found that 95% of payers, 83% of hospitals & 75% of providers thought that publicly funded HIEs had flawed business models & provided no meaningful connectivity. Let’s look at each of these separately.

Public HIEs’ business (sustainability) models are dominated by the $546M in funding provided by the HITECH Act. As this funding ends (actually, it has ended), public HIEs have had to try to develop other means of sustaining their operations. Among these have been charging (large) fees to stakeholders, but HIE stakeholders are in very different positions relative to paying for services. Most provider organizations are not in the position of being able to pay large amounts for HIE capabilities. Many do not have the financial resources to do so, & those that do, like the big payer/provider organizations, do not want to pay for capabilities that have not been shown to be essential (yet?).

A second potential means of providing sustainability is the development & offering of new capabilities: IT & data management, data warehousing, analytics & nontechnical capabilities such as financial management services. Charging constituents for these services could provide financial stability, but first those services have to be developed to a point where an organization (that may already be doing much of this) will pay for them. This is not as easy as it seems.

The real bottom line, in my opinion, though, is that HIEs have yet to provide a service that is necessary. The original use cases that consisted of a patient serendipitously needing emergency or trauma care far from their primary healthcare provider just does not happen often enough to sustain a half billion dollar investment & less ambitious use cases are not compelling for providing needed care. If HIEs were to develop a model that provided information for care in situations that actually exist in the real world, there would not be a sustainability problem. I work quite a bit with Federally Qualified Health Centers (but the same example is mostly true of ambulatory care in general), & many people who get their ambulatory care at FQHCs get trauma-based (& a good deal of other care) care at hospital EDs. This is especially in urban environments. A person getting their care at one of the Ryan Community Health Network sites in Manhattan, NY could potentially get non-ambulatory care at any one of hundreds of hospital sites. They might have to choose from 10-25 hospital sites in walking distance. What happens when they walk into one of those sites? Chances are that the years of medical records from their health center, or even just their medication history, will not be available to the ED providers. This is a sustainability model right here, & it doesn’t have only to be in NYC.

Of course, the other issue with HIE is that they actually have to work – that is, they have to be able to share critical clinical & administrative data among constituents. This is only incompletely realized in most cases & will have to substantially improve before any sustainability model can succeed. The proof of this is the amount of vendor churn in HIE. I wrote about this as early as 2011[2], & my current observation is that the situation has not changed for the better with many HIEs looking to change their vendor. Much of this is connected to EHR churn as a 2013 survey[3] found that one in six medical practices were looking to change their EHR vendor in 2013 & one of the primary reasons was HIE support.

What can be done to improve this situation?

• First, vendors must provide the connectivity & interoperability for data sharing that users require in order to have the basic functions of an HIE work. Sustainability is a moot issue if the HIE is not providing adequate function.
• If HIEs are to provide additional services (beyond the connectivity & interoperability capabilities referenced just above), then they must provide those services that users want & need, & they must do this in a way that makes these services easy to understand & to use. Examples might include: 1) data warehousing including ETL & normalization so that the data is usable, 2) analytics related the warehousing including “canned” analyses for a “top 10” list of questions/issues, 3) support for accountable care, 4) outsourced IT management etc.
• Capabilities for more “local” data sharing aligned with healthcare usage of the patient population being served.

This brings us to ACOs. Section 3220 of the Affordable Care Act established the Medicare Shared Savings Program & CMS published a final rule on this program in November 2011[4]. ACOs are healthcare organizations that commit to share savings & risks for at least 5,000 Medicare fee-for-service patients. Simply put, the cost of care for these patients is compared to CMS benchmarks & if the organization’s cost is at least 2% less than the benchmark, they qualify to “share” in the savings through higher reimbursements. There is also a shared risk model which organizations opt into where if the savings are below benchmark level (i.e. no savings), the organization may be required to pay CMS back part of it’s reimbursement. The details are, well… substantially more detailed, but you can read the 190 page regulation yourself if you are interested.

So how is this program doing? If we look at the first year of the ACO Pioneer program we can see pluses & minuses. CMS selected 32 advanced healthcare organizations for the Pioneer Program. Of these, nine (28%) dropped out in the first year for various reasons. 13 organizations (41%) were paid bonuses for showing savings. CMS’ estimate for savings totaled $87.6M that is .015% of Medicare expenditure for 2013. Participants’ issues with the program, including those that dropped out, centered around administrative complexity & the relatively small amount of reimbursement compared to the effort of producing savings. If CMS’ expectation is that some form of this program will eventually replace fee-for-service payments, they have a very long way to go.

Why, then, are so many HIEs focused on morphing into ACOs? The answer seems pretty straightforward – sustainability. ACOs offer one of the few models for a healthcare organization that pays money for a level of care & cost savings that the organization would want to achieve in any case. The real question is: “Is this a good idea?” The answer would be yes if it were easy to provide “accountable care” to 5000+ Medicare patients in such a way so that their outcomes were improved & cost savings could be measured against a CMS benchmark. This does not seem to be the case, though. If some of the best healthcare organizations in the country are having trouble providing improved care with the required “shared savings”, then it will be difficult for less well-resourced organizations to do so.  An example would be Texas Health Resources (consisting of 13 hospitals, managing 41,000 Medicare beneficiaries in their ACO), a 2013 HIMSS Davies Award winner for EHR adoption. THR dropped out of the Pioneer Program as they failed to achieve shared savings & would have owed CMS $6M-$9M by the end of 2013[5]. As always, my question is what can be done to improve the situation, although I have to admit we are in very early days with ACOs & I have not worked much on this… however that never stopped me from making suggestions[6]:     

• Every aspect of the program has to be simplified. This includes how savings & benchmarks are calculated, eligibility requirements, administrative requirements, reporting,… every aspect.
• Some program details have to be rethought:
• The amount of reimbursement (shared savings returned) needs to be concomitant with the effort to create those savings. The best data we have on how this might work is from the Physician Group Practice demonstration[7] run by CMS from 2005-2010. If a new ACO made the same investment that the PGP demonstration groups did in their first year ($1.7M), they would need to make a 20% profit to break even over their first three year ACO contract. This seems unlikely.
• Patients in the ACO need to be able to be identified. It is very difficult to measure things like hospital readmissions (& many other quality measurements) if all you have are statistical characterizations. If ACOs are going to be about improvements in population health, then that’s what they should be measured on.
• CMS must do better in coordinating sharing of claims & other data so that participating organizations have the data they need to monitor quality & costs.
• A realistic care model must be part of the ACO model. We know from looking at HIEs that most patients get their care both within the HIE & outside of its participants. The same is true of ACOs, & so the shared savings must take this into account. ACOs cannot be held accountable for patient-driven costs that the organization is not involved in, but they are currently held responsible for overall quality of care & all costs. Conversely all relevant costs need to be taken into account if cost is going to actually be reduced. I don’t know what the answer to this one is, but it needs to be worked on.
• Part of the problem with the shared cost model is that savings are in part calculated on growth rates from a national sample. CMS’ own data[8] show that most ACOs have costs in line with their region & local areas, & that these may differ greatly from the national averages. Costs need to be evaluated based on local conditions, especially where those are different from national averages. 

So,… a lot of issues with HIEs & ACOs. Are these organizational & clinical models the future of healthcare delivery? CMS seems to want to evolve the ACO model into an eventual replacement for their Medicare fee-for-service model. Anything that realistically moves us away from fee-for-service models, & also improves outcomes while reducing costs is an essential & welcome change to the system. Are HIEs a step along this path? For all of the investment in HIEs, greater than $0.5B to date, I do think that they are a temporary step. HIEs need to continue to find sustainability models. I do not think that their governance model lends itself to profitable service provision (not what they were designed for) & the sharing of healthcare data over large distances also does not seem to be a sustainable model. One question to ask about HIE sustainability is: “Were these organizations meant to be self-sustaining businesses?” Obviously, their evolution to ACOs is one way to deal with the major issue facing them, but that then begs the question of whether the majority (or even a small number) of the approximately 250-280 HIEs in the country can successfully make this change, & if they do, can they succeed as an ACO? I think the answer is no unless CMS works with healthcare organizations, payers & all constituents to evolve the ACO model to be simpler, both to qualify for shared savings & to improve the incentives to do so.

Coming up:

•         Many people, myself included, have said that healthcare is really not a market. What does this mean in terms of our current reform effort? & what are its implications for the future healthcare system?
•     Other core industries have done substantial re-engineering work that made them much more effective. Has this work been done in healthcare? What would doing it look like?
•     To be supplanted by relevant & interesting topics as they come up… 

That should be enough for a while…

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[1] http://www.prweb.com/releases/2014/01/prweb11503131.htm

[2] http://www.hiewatch.com/perspective/change-good

[3]http://www.questdiagnostics.com/dms/Documents/hit_quality_solutions/qs_vendor_enewsletter_oct2013.pdf

[4] 42 CFR Part 425 Medicare Shared Savings Program: Accountable Care Organizations. Federal Register 76(212).

[5] THR has said the two biggest impediments to achieving shared savings were lack of CMS to provide timely claims data (to monitor quality & cost) & lack of ability to coordinate care for managed patients seeking care outside of the ACO. Other organizations had these same problems. http://www.modernhealthcare.com/article/20130720/MAGAZINE/307209949/1138. Accessed 3 April 2014.

[6] At the Digital Equipment Corporation, we used to say that the (unofficial) Consulting Engineers’ motto was “Often wrong, never uncertain!”

[7] Health Affairs. Health Policy Brief. Next Steps for ACOs. Health Affairs Blog. January 31 2012.

[8] http://innovation.cms.gov/Files/reports/PioneerACOEvalReport1.pdf

HIEs & Provider Engagement - A Possible Solution?

Quite a number of threads are coming together this winter as meaningful use meets HIEs meets ACOs meets patient engagement meets provider engagement meets… A lot of meeting going on, but not much in the way of effective outcomes including clinical outcomes. Several reviews of HIE & ACO effectiveness have recently presented statistics, or at least a series of numbers, appearing to show that HIEs have not captured either payers or providers approval as a way of sharing healthcare information that is productive & cost-effective, & that ACOs have, for the most part, not delivered on the model of shared savings & so have proved riskier than initially hoped. Of course, the jury is still out on both of these models, but the initial results are not highly positive.[1]

HIEs are having a hard time, especially the public HIEs originally funded with HITECH money. The cited report states that “95% of payers, 83% of hospitals and 70% of physicians said HIEs funded by federal grants have flawed business models and do not assist with meaningful connectivity (Goedert, Health Data Management, 1/27)”. “In addition, 94% of surveyed payers said they did not see any "value proposition" in public HIEs (Sullivan, Government Health IT, 1/27)”.

Coincidentally, the value of EHRs is also being questioned. A recent survey by the MPI Group & Medical Economics found that 45% of physicians believe that healthcare is worse as a result of EHR adoption & 43% believe that EHR systems have resulted in significant financial losses. In fact, 79% of doctors in practices with more than 10 physicians said that their EHR investment was not worth the effort, resources or the cost[2].

ACOs fare no better. Less than half of the 114 ACOs surveyed in 2013 reduced per patient spending at all & only 25% (29/114) broke even or reduced spending. In the Pioneer ACO program, 9 of 32 organizations exited the program after the first year & only 9 of the remaining 23 (39%) reduced spending enough to receive shared savings. In both cases, this is far below HHS’ or other policy makers’ expectation.

So why did I include engagement in my introduction? I believe that engagement, both provider & patient, is key to developing & maintaining sustainable operational & business models for both HIEs & ACOs. I’ll address HIEs in this post & ACOs in a subsequent one.

A recent IDC Health Insights report[3] makes the controversial statement that current EHR technology & by implication Stage 1 & 2 meaningful use have failed. By this they mean that even if you qualify for meaningful use, you will not have the tools available to actually improve clinical outcomes, improve population health & reduce costs[4] - & I can’t disagree. To do so, you would need real capability for at least: provider-to-provider connectivity, provider-to-patient connectivity, & clinical/ operational functions such as care transition & medication reconciliation. Most EHR vendors would claim to provide all of this, but the experience of providers & their staff in actual healthcare organizations would indicate that the capabilities that are provided are often incomplete, inadequate or just don’t work very well[5].

So back to engagement… The fact remains that providers are laser-focused on patient outcomes, & not surprisingly, so are patients. If providers felt that EHRs, & other health information technology used during patient encounters, were helping to improve outcomes, they would be 100% in favor of them. The same is true of HIEs. The fact that they are not highly supported by providers only means that their design & implementation, including the workflow changes needed to utilize them productively, has not yet been directed at what providers & healthcare organizations (including payers) need of them.

I have previously written (& will write again) about the importance, indeed the necessity, of integrating new technology into clinical & administrative workflows so that providers & the staff of healthcare organizations are comfortable with using the technology. This is true whether it is a practice management system, an EHR, a public health reporting system, ePrescribing, CPOE, clinical decision support or any other technology-enabled capability. It is doubly true for HIEs. What is the appropriate integration point, technically & operationally, to introduce information from external sources into a provider’s workflow? I don’t know if there is a “right” answer, in fact I suspect that there are several workable answers, but it seems that HIE-level workflow integration of external data should not be all that different from the integration of data from internal sources (PM, EHR etc.). Other than identifying the source of the information, it should be the same. This way there are not several different “informational interruptions” as the provider works with the patient.

Here are some guidelines for engaging providers in HIE:

•       The technology must be well-aligned with the actual work being done (not some idealized or aspirational view of the work)
•        The technology must provide capabilities that allow providers (& other users) to perform their work more efficiently &/or effectively
•       The technology must be simpler to use than the current means of accomplishing the work
•       If it is not simpler, it must provide substantially more of the capabilities needed to accomplish the work such as:
•       Provider-to-provider connectivity: eReferral, Direct messaging
•       Patient-to-provider capability: email, SMS or other (secure) messaging, social media interaction
•       Care continuity & transition tools
•       Medication reconciliation tools
•      Integration with public health & emergency services systems
•      Others as shown to be necessary
•      Information must be pre-loaded so that it is available for access when the provider is with the patient
•      Information should be presented when the provider accesses similar local data (medication history, encounter history, etc.) or on demand by user, but not at other times
•      Information source should be presented so that the user can have an idea of data credibility
•      Alerts should be kept to a minimum (or level should be adjustable) so that “alert fatigue” can be avoided

This set of guidelines is: informal, incomplete, experiential, but also may provide a way to engage the provider in HIE usage. The data presented from external sources should be smoothly integrated with the provider’s workflow so that it is presented as an enhancement to local available data, not as a separate set of requests or in a separate workflow. More data can lead to better diagnosis, treatment & outcome which is a win for both provider & patient, & which can provide more provider engagement (& patient satisfaction) & a better sustainability environment for the HIE.

On the administrative side, non-local demographic & patient financial data provided under the same guidelines (except for capabilities) can improve the financial understanding of the HIEs operations & lead to both cost reduction & greater efficiency.

Once HIEs are really facilitating accomplishing the triple aim (better patient outcomes, improving population health & per capita cost reduction), they will have reengaged providers & be on their way to relevance & solving the sustainability problem.

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[1] http://www.healthdatamanagement.com/news/hie-survey-offers-sobering-results-on-value-47151-1.html, Health Data Management accessed 30 January 2014.

http://www.modernhealthcare.com/article/20140130/NEWS/301309951/providers-net-uneven results-from-aco-experiment?AllowView=VXQ0UnpwZTVDL2VlL1IzSkUvSHRlRU9vakV3ZEErTmM=#. Modern Healthcare. Accessed 30 January 2014

[2] http://medicaleconomics.modernmedicine.com/medical-economics/news/physician-outcry-ehr-functionality-cost-will-shake-health-information-technol?page=0,0

[3] http://www.healthcareitnews.com/news/new-do-lists-loom-post-ehr-era?single-page=true. U.S. Healthcare Provider Predictions for 2014. Accessed 3 Feb 2014.

[4] The triple aim, c.f. D. Berwick et al. 2008. The Triple Aim: Care, Health & Cost. Health Affairs. 27(3), 759-769 & many others…

[5] personal communication with many providers & other healthcare professionals