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.

Healthcare as a Market...

[1]In my last post, I wrote about what re-engineering efforts might be like in healthcare & why they might be relevant & productive. I also mentioned (as I have several times in these posts) that re-engineering worked well in segments like automobile manufacturing & aerospace because these industries operated primarily as an actual market, but that it might not work as well in healthcare because healthcare does not operate as an actual market. What does this statement mean? & Why is it important in understanding the possibilities for healthcare reform & the potential evolution of healthcare? In order to understand we need a little Economics 101 on what markets are & how they operate.

What is a market, & what characteristics do economies that depend on markets exhibit[2]? A simple definition of a market economy would be: “an economy in which decisions regarding investment, production and distribution are based on supply and demand, and prices of goods and services are determined in a free price system[3]” Such an economy would several essential characteristics:

•         Limited government control & intervention
•    Extensive cost & price transparency
•        Competition in costs & prices based on this transparency as well as the quality of goods & services

Let’s look at each of these characteristics with respect to healthcare.

The Gross Domestic Product, that is the value of the total output of all goods & services in the country, for 2013 was $15.8 Trillion (with a T). We’ll use this as a baseline for other values. Total healthcare spending in the U.S. in 2013 was $2.94 Trillion[4] or 18.6% of the GDP. Total government spending[5] on healthcare in 2013 was $1.22 Trillion or 7.8% of GDP & 42% of overall healthcare spending. This is important for several reasons.

First, we can hardly assert that this market has limited government control & intervention if federal spending on healthcare is 8% of the GDP & 42% of total healthcare spending (for 2013, earlier years have similar percentages). $1.22 Trillion is a lot of money, even by Everett Dirksen’s standard[6], but of course, he was allegedly only talking about billions. Even so, the influence of the federal government, just on the spend side on healthcare, is immense. This influence is separate from the legislative & policy impact of the federal government on healthcare. Both the HITECH Act[7] & the Patient Protection & Affordable Care Act[8] have substantially influenced healthcare in this country. All told, healthcare is far from independent of government influence.

Second, price in healthcare is not transparent. Several recent studies have shown differences in healthcare charges that are both regional & within regions. In fact, it is quite possible that hospitals across the street from each other may charge substantially different amounts for the same procedures. One of many, many possible examples is that an uncomplicated birth at Bellevue Hospital (Manhattan, NY) costs the patient $6,330 (median), while next door at NYU Langone Medical Center the cost is $12,222[9]. A recent Institute of Medicine report[10] found that difference in Medicare costs had to do with the large variation in the cost of post-acute services such as home health care, while differences in commercial insurance costs were mainly caused by the wide difference in reimbursement that doctors & hospitals negotiate with individual insurance payers. These differences in cost to patient are not evident, unless one makes it their business to find them out. Even then it’s difficult, as many healthcare organizations are not inclined to make this kind of information readily available.

There are two other issues with transparency: the actual cost to provide a service is not available or sometimes not even known, & both Medicare & Medicaid costs are fixed but Medicaid costs are set by each individual state based on differing sets of criteria & standards of care. This pretty much ensures that a “consumer” of healthcare services will not have real transparency for either the price they pay for a service or what that service costs their provider. We won’t even discuss the fact that a provider may charge the patient one thing, Medicare may pay 10%-25% of that to the provider & the patient may be billed a fraction of the difference. We’ve all gotten the (in)famous Explanation of Benefits (EoB) form that states at the top: “THIS IS NOT A BILL”. Transparency in both price & cost is just not available in healthcare.

Finally, does competition on cost & price exist in healthcare? In a real market, competitive forces would act to minimize both production cost & price.  In other industries, competition is a fact of life – automobile manufacturing was mentioned at the beginning of this post. Price & cost competition are key drivers in structuring this industry as well as determining what the price of goods to consumers is. This does not appear to be the case in healthcare as situations such as the one cited above for Bellevue Hospital (1^st Avenue & 26^th Street, NYC) & Langone Medical Center (1^st Avenue & 29^th Street, NYC) show that very different price (& cost) structures exist & are tolerated virtually next door to each other. This is not an atypical case.

So, it really doesn’t appear as if healthcare is structured like or acts like a market. It is very heavily controlled & influenced by the federal government, both financially & legislatively. It does not have price or cost transparency, & it also does not appear to exhibit price or cost competition in a conventional sense[11]. What might this mean for healthcare reform & evolution?Re-engineering, that is the systematic modification of business process & practice to align with corporate goals & customer needs, can be done regardless of the economic environment that an organization exists in. It is, however most effective, when that organization exists in a market economy. Competition on cost of goods, consumer price & quality of goods produced drives a number of organizational strategies including:     

• The need for “continuous improvement” in lowering cost, aligning price with customer expectations & improving the quality of good produced; this, in turn, drives:

o   Efficiency in the use of capital, such as research & development investment

o   Innovation in both process & product

o   Strategies focused on customer needs.

Without competition, an organization has no need to focus on these types of efficiencies. Without price & cost transparency, there is no real competition & in an economy heavily influenced by government, organizations have fixed strategies aligned with government requirements, not customer needs. As we have seen, healthcare is a very mixed economy with substantial government influence, little transparency & limited competition. We talk a lot about the need for more effective & efficient use of R&D investment (new medical devices, more spending on clinical & public health infrastructure, etc.) & innovation (modified clinical & administrative practice, new health information practices, etc.), but the primary vehicles for much of this are legislative. The use of electronic health records is a step that is inevitable, but meaningful use (HITECH Act) is a legislative requirement, not an organic development arising from perceived patient needs.

So, you say, what can be done? It seems clear (at least to me) that government must play some role in the evolution of healthcare from where it is as a mostly planned market to a more efficient open market. The kinds of large changes that are required may eventually happen as healthcare evolves, but we do not have 15-20 years (in my humble opinion) for this to happen organically. The government has already acted to try to institutionalize innovation in the form meaningful use of electronic health records. This program needs to evolve (possibly in Stage 3) to start moving at least this portion of the healthcare segment toward a better market profile. What does this mean?

There are several directions that I think can be productive here:

•         Make healthcare substantially more patient-centered – There are a lot of initiatives around this, but patient-centered needs to really mean people taking responsibility for shared decision making[12] with their providers. This, in turn, means that people need to be able to access the information they need including information on at least: treatment options & effectiveness, provider performance, as well as price & cost transparency. This type of information is not currently readily available or when it is, understandable, but that needs to change. This type of decision-making will drive competition as transparency & quality of product (patient experience & outcome) make people better consumers of healthcare services.

o   Programs such as Meaningful Use, PCMH, etc. need to emphasize making this information available to patients & facilitating this type of decision making.

•         Provide guidelines & best practices for workflow modification to focus on patient-centered care. This does not necessarily have to be done by the government, although some initial projects & seed funding could be helpful. Many organizations are in the process of making changes to workflow in order to better align with the use of EHRs, but the emphasis really should be on patient-centered care, not meaningful use. This would emphasize such processes as:

o   Simplified administrative workflow for intake & patient information gathering

o   Clinical workflows emphasizing:

§   Co-ordination of care between & among care teams

§  Care transition from team-to-team & location-to-location

§  Realistic medication reconciliation that allows for not just prescription & claims data, but actual usage data gathered from the patient & other sources

An organization such as the Institute of Medicine, the Kaiser Family Foundation, the Robert Wood Johnson Foundation or any of a large number of credible clinical organizations could begin by making their current processes &/or proposed guidelines available.

These suggestions are just a beginning. Healthcare needs to evolve to be a market driven by: customer (patient) needs, competition & innovation & patient participation in order to begin to address cost control (both cost of services to providers & to patients) & improvement of outcomes. Government programs are inevitable at this stage of market development, but they will be successful only to the extent that they facilitate the evolution of healthcare to a more open market.

Coming up:

• Who actually is the “customer” in healthcare. This question is key to market development.
• Lessons learned from the Path to Analytics Project (in progress)
• Revisiting the GM C4 Project & what it tells us about healthcare evolution

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[1] Image, HPHSmedia, http://www.hphsmedia.com/?p=1851

[2] Please Note: There is a good deal of political content & controversy associated with the idea of markets & how they do & should work. I am not advocating any political position, but simply trying to use generally accepted ideas of markets in relation to healthcare & healthcare reform.

[3] http://en.wikipedia.org/wiki/Market_economy

[4] GDP figures & all healthcare spending figures from: CMS National Healthcare Spending Projections 2011-2021, http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/Proj2011PDF.pdf

[5] includes: SCHIP, DoD, VA, workers compensation, Indian Health Service & other federal programs

[6] “A billion here, a billion there, pretty soon you’re talking about real money”, apocryphal but attributed to Everett Dirksen (R. IL) speaking about taxes

[7] Title XIII, PL 111-5 (42 CFR §412-413, §422, §495)

[8] PL 111-148 (45 CFR §144-§156)

[9] http://www.kaiserhealthnews.org/stories/2013/december/12/ny-state-hospital-charges-vary-wildly.aspx

[10] Institute of Medicine. Variation in Health Care Spending: Target Decision Making, Not Geography. Washington, DC. The National Academies Press. 2013

[11] It should be noted that it does exhibit competition on services, but not on the price or cost of services.

[12] See my post on Clinical Workflows & Other Arcane Rituals (12/16/13), http://posttechnical.blogspot.com/2013/12/clinical-workflow-other-arcane-rituals.html