Tuesday, April 29, 2008

Coordinating Less; Accomplishing More

On April 28, Government Health IT published an op-ed piece with my consent and participation. It was based on a longer and more spontaneous blog entry at this site. It had its roots in my wish to see more focus and immediate wins in areas that will raise the larger questions.
In this op-ed piece, I said:

"One hopes a smaller set of high-priority items will emerge that can be adopted across the health care sector. I believe about 12 of the core services are must-do high priorities, and many others could be set aside for future consideration."

I was commenting on the bewildering array of features and functionalities described in the Gartner NHIN I report. These features are actually more bewildering because each use case in turn added features and desiderata that may or may not be congruent with the larger NHIN list. The simple fact: there are a lot of things that would be nice to have, but the list of things we must have in a "Version 1.0" world may be fewer in number and complexity.
For each, I the pdf document linked above cross-references the relevant NHIN reports. Summarizing in a few words, the 12 core services are:
  1. Data delivery
  2. Look-up
  3. Matching
  4. Summary patient records
  5. Integrity
  6. Choice
  7. Audits
  8. Identity
  9. Authentication
  10. Management
  11. Security
  12. De-authorization
These may be the wrong items, and there may be differing priorities, but this writer at least believes starting with some of the NHIN terms - using these terms and supporting their evolution over time through thoughtful study - seems like one approach.

Monday, April 28, 2008

Russell Ackoff and Mission Statements

Participating in the AHIC 2.0 discussions, I am repeatedly reminded of an influential talk and paper delivered by Russ Ackoff several years ago. His advice should be heeded when one is talking of ambitious, sincere, and inclusive "public private partnerships."

I have located a copy of this paper attributed to him on Charles Warner's Web Site. It seems to be the paper I read long ago. I reprint in full. Emphases in bold or italics are mine.

Russell Ackoff

Most corporate mission statements are worthless. They consist largely of pious platitudes such as: "We will hold ourselves to the highest standards of professionalism and ethical behavior." They often formulate necessities as objectives; for example, "to achieve sufficient profit." This is like a person saying his mission is to breathe sufficiently.

A mission statement should not commit a firm to what it must do to survive but to what it chooses to do in order to thrive. Nor should it be filled with operationally meaningless superlatives such as biggest, best, optimum, and maximum; for example, one company says it wants to "maximize its growth potential," another "to provide products of the highest quality." How in the world can a company determine whether it has attained growth potential or highest quality?

To test for the appropriateness of an assertion in a mission statement, determine whether it can be disagreed with reasonably. If not, it should be excluded. Can you imagine any company disagreeing with the objective "to provide the best value for the money." If you can't, it's not worth saying.

What characteristics should a mission statement have?

First it should contain a formulation of the firm's objectives that enables progress toward them to be measured. To state objectives that cannot be used to evaluate performance is hypocrisy. Unless the adoption of a mission statement changes the behavior of the firm that makes it, it has no value. The behavior of a Mexican firm was profoundly affected by the following passage from its mission statement:
To create a wholesome, varied, pluralistic, multi-class recreational area incorporating tourist facilities and permanent residences, and to produce locally as much of the goods and services required by the area as possible, so as to improve the standard of living and quality of life of its inhabitants.

Second, a company's mission statement should differentiate it from other companies. It should establish the individuality, if not the uniqueness of the firm. A company that wants only what most other companies want--for example, "to manufacture products in an efficient manner, at costs that help yield adequate profits"--wastes its time in formulating a mission statement. Individuality can be attained in many ways, including that in which a company's business is defined.

Third, a mission statement should define the business that the company wants to be in, not necessarily is in. However diverse its current business, it should try to find a unifying concept that enlarges its view of itself and brings it into focus; for example, a company that produces beverages, snacks, and baked good and operates a variety of dining, recreational, and entertainment facilities identified its business as "increasing the satisfaction people derive from use of their discretionary time." This suggested completely new directions for its diversification and growth. The same was true of a company that said it was in the "sticking" business, enabling objects and materials to stick together.

Fourth, a mission statement should be relevant to all the firm's stakeholders. These include its customers, suppliers, the public, shareholders, and employees. The mission should state how the company intends to serve each of them; for example, one company committed itself "to providing all its employees with adequate and fair compensation, safe working conditions, stable employment, challenging work, opportunities for personal development, and a satisfying quality of work life." It also wanted "to provide those who supply the material used in the business with continuing, if not expanding, sources of business, and with incentives to improve their products and services and their use through research and development."
Most mission statements address only shareholders and managers. Their most serious deficiency is their failure to motivate non-managerial employees. Without their commitment, a company's mission has little chance of being fulfilled, whatever its managers and shareholders do.

Finally, and of greatest importance, a mission statement should be exciting and inspiring. It should motivate all those whose participation in its pursuit is sought; for example, one Latin American company committed itself to being "an active force for economic and social development, fostering economic integration of Latin America and, within each country, collaboration between government, industry, labor and the public." A mission should play the same role in a company that the Holy Grail did in the Crusades. It does not have to appear to be feasible; it only has to be desirable.
"man has been able to grow enthusiastic over his vision of ... unconvincing enterprises. He has put himself to work for the sake of an idea, seeking by magnificent exertions to arrive at the incredible. And in the end he has arrived there. Beyond all doubt it is one of the vital sources of man's power, to be thus able to kindle enthusiasm from the mere glimmer of something improbable, difficult, remote."
If your firm has a mission statement, test it against these five criteria. If it fails to meet any of them, it should be redone.

Friday, April 25, 2008

"The Billing System We Use Is Insane"

These are not my words. According to Government Health IT's coverage of the World Healthcare Congress, these are the words of Secretary Michael Leavitt, a man who understands that the bureaucracy for which he is responsible is to a significant degree responsible for this sad state. (The transcript of the Secretary's talk as of April 25 "has been removed to update and will be posted again later this week.") But this remark seems to be less an indictment on those who try to navigate the complex health care financing landscape and more a global indictment that we - as citizens - have allowed for the evolution of such a complex and absolutely inscrutable array of details that increasingly takes valuable health care dollars away from the quality of care and into the myriad organizations who are scrambling to administer and maintain compliance with the regs. It is almost as if one says "spend more money on complexity and compliance at the expense of better health care, or go to prison for fraud."

The real thrust of the Secretary's remarks seems to be focused on the importance of his "Four Cornerstones" and his urgent plea for the health care industry and the public to understand that change is critical, it takes time and it requires both vigilance and persistence. According to News-Medical.net's coverage, the Secretary said "Better information about quality and cost will not appear all at once, nor will the benefits of its use," adding, "It will happen gradually over the next decade, but we will get benefits at every step in our progress. ... So it is with every social and economic transformation." He added, "My hope is we will see a foundation that others can build on."

The Secretary was speaking to the World Healthcare Congress - an audience that is both part of the solution and part of the problem. If one looks at the speakers, it arguably is, as the banner add quoting the CEO of Wal-Mart says: "This is the largest gathering of health care providers, thinkers and experts anywhere in this world…." (Of course, a convocation of these professionals in a hotel may not lead to any more action than if they happened to find themselves in Reagan Airport at the same time.)

This writer views the World Healthcare Congress with a slightly jaded eye. To some extent it is a positive "group think" on the pulse of the health care industry that provides participants wiht a broad overview of current opinion, in another sense it is the quintessential "defensive meeting" where everyone goes to see what their competitors are up to. It would be interesting to view the average gross income of the speakers; by and large, these are powerful people who profit a great deal from the status quo. It is very much these people who must be convinced - through argument or legislative coercion - to accelerate their efforts to improve the collective health of the public even if at slight expense to their own short-term financial gain. Without such improvements, a far more adverse public response is a matter of months or years, may be inevitable.

Let's revisit Secretary Leavitt's Four Cornestones and understand why they are important and why their intent - if not the means of implementation - should transcend any changes in the Executive or Congress. The Four Cornerstones are:
Her is my brief take on where we are and where we should be on a few of these cornerstones:

Interoperable Health Information Technology (Health IT Standards)
  • Adoption of standards by a committee is not the rate-limiting step, it is adoption of standardized products in the marketplace. Indeed, one can be "certified" as a vendor but offer older versions of software products that do not meet certification criteria. Furthermore, there is an issue of granularity. Some standards (e.g., NCPDP SCRIPT) are fairly non-controversial. Others (ICD-10) actually reinforce the very complexity that this writer believes to be at times a threat to innovation and consumer value.
  • The Secretary is promoting e-Prescribing (disclosure: this writer is a member of the SureScripts Board - an organization that shares this enthusiasm). E-prescribing, or more broadly, medication management, is a critical requirement, but the degree of social change required is underestimated by many enthusiasts. There are issues of authentication, authorization, pharmacy workflow, prescriber back-office work changes, and incentives (e.g., pay the prescribers and pharmacists - not third party disease management companies - t0 foster compliance among the people they care for). Additionally, some of the e-prescribing standards were not sufficiently evaluated in the rushed CMS pilot and need more work - notably RxFill, RxNorm, and prior authorization. Here the issue again is not the standards but the very complexity of process. What is needed is not more high-level technology standards groups but a systematic, grass-roots, community-based program to work through the technical and cultural issues pharmacy-by-pharmacy, clinic-by-clinic and consumer-by-consumer. Much is being done here by consumer advocates, pharmacy groups, and clinicians; all see the benefit of a safe and effective medication management infrastructure. The Federal government should telegraph its commitment to push society into a digital world, but it should be respectful of the complexities often ignored when enthusiasts, full of excitement, promulgate before federal groups in Washington.
  • ACTION: Keep it simple. Work on a safe and effective, national program for medication management - a win-win for all - and get that right. This activity will bring up most of the other issues that are critical to Health IT adoption. Add to the mix clinical laboratories, and clinicians will have great incentives to adopt.
Measured and Published Quality Information (Quality Standards)
  • How can one argue with this? But as has been stated, quality is an elusive thing and is to some a "multi-agent, multi-attribute utility model problem." That means that different people have different view of what quality is and that different attributes contribute to our overall perception.
  • Our problem? The lingua franca of quality metrics are claims data. These data are designed for accommodating the ever-evolving complex reimbursement schemes. Why should one assume that an increasingly complex claims infrastructure will necessarily be optimal for quality measurement? And if we are increasingly and justifiably moving to a transparent, price-oriented, consumer-driven health savings account structure, shouldn't quality be defined in terms we understand and not in terms of complex claims? Fortunately, many federal agencies and organizations focusing on quality are doing just that.
  • ACTION: Promote quality metrics that mean something to the individual and that foster long-term well-being. These metrics should complement internal, delivery-focused quality metrics that should arise naturally if providers - particularly hospitals and other large delivery organizations - are paid for doing the right thing and not necessarily just "doing more."

Measured and Published Price Information (Price Standards)
  • This is ideal, but problematic. Again one would benefit from trying the simplest thing first. But aside from immunizations and commercial, over-the-counter offerings, what should be the first issue? I'd argue for clear and understandable prescription drug prices. The problem? No one I know is quite sure what a prescription drug really costs various suppliers, pharmacists, and consumers. I tried to summarize what little I knew of this in a blog entry about a year ago - pricing of prescription drugs. I will update this soon.
  • ACTION: We should continue to look to the large pharmacies to push prices for common drugs. We should assume that price pressure for specialty drugs and other offerings will continue but that the true costs and rebates will remain controversial. Two things must be distinguished when looking at specialty drugs: the high cost of these miraculous drugs and the hidden profits. Unfortunately, even great journalism from organizations like the New York Times sometimes confuse the two issues. (See Milt Freudenheim's insightful but somewhat flawed piece in the April 19, 2008 issue.) Ironic that in an era where drugs literally save lives (including those of people I love), the cost of these are not compared more rationally to the costs of other interventions or, something more acute - simple things like gasoline and other failed policies.
Incentives: Promotion of Quality and Efficiency of Care (Incentives)
  • The vision is a good one. If one has price information, quality information, and rational decision-makers, one will get good results. The challenges are several. First, most long-term wins in health come at the expense of short-term sacrifice (remember this principle the next time you grab for a cookie!). Second, our very human sense of denial comes into play. I'm not going to get sick, it's going to be the other guy. How else can one explain well-educated professionals in their 20s going without health care coverage? Third, we have competing priorities. When one is paying off one's credit cards and yearning for a plasma TV, emphasis on deferred gratification and long-term tax benefits just don't have much influence.
  • This writer agrees that, by and large, health professionals, like other small business people, should pay for their own information technology, but where health care providers are concerned, the infrastructure and connectivity simply are not there. So imposing electronic health records before they can communicate and individual's information to wherever it is needed is a bit like mandating telephone purchases before the telephone switches and other communication allow one to use the telephone to talk with others. One example: providing e-prescribing incentives to providers in rural communities when rural pharmacies do not have the capabilities to received e-prescriptions! In some instances, a Hill-Burton type capital infrastructure approach seems relevant. But the approach could be revenue bonds or some other debt instrument and not outright grants. If we achieve the equitable system many envision, cash flow should offset expenditures across all sectors required to make an investment. But until we get the pump primed, we won't see this laudable effect take place in a systematic way.
  • ACTION: Once again, pick a few things and achieve evolutionary progress. The overall emphasis on smoking cessation and exercise are two examples of success in some enlightened employer-sponsored programs. But these efforts do little for the unemployed and isolated. As someone observed in a recent conference in Puerto Rico, virtually everything in our environment - from sidewalks to staircases - can be designed and promoted as ways of improving health. But often they are not.
  • ACTION: In addition to creating a social climate for better health, one can continue a trend that is growing in popularity: focusing on prescription drug adherence, find a suitably priced effective drug (often a generic) and create incentives that actually cost a consumer less if they take medications regularly rather than intermittently. Or, a more controversial pick, provide all pregnant women with a financial reward for behaviors that reduce low birthweight infants (e.g., nutrition, vitamins, smoking cessation). Don't think of it as welfare; think of it as cost-avoidance resulting from fewer premature infants. Think of it as an investment in the next generation to ensure they start off in healthier shape.
This writer doesn't know very much, but it's hard to argue with the passion and principles espoused by Secretary Leavitt. Although partisanship always dominates the Washington debate, there is nothing partisan in the principles espoused; they are a great start and an essential prerequisite for effective decision-making. There are clear philosophical differences about priorities and execution among various groups both within and among various political parties, but every candidate and white paper has some points worth pondering.

The real question? What will the organizations represented by the speakers and audience at the World Healthcare Congress do to advance these aims? They represent enlightened and knowledgeable groups with focus, finances, and the wisdom to change on their own behalf before change is imposed from without. But what will these organizations do? And what will it mean to those of us (all of us), whose lives and well-being are at risk?

Wednesday, April 16, 2008

Tectonic Shifts in the Health Information Economy

In the April 17, 2008 edition of the New England Journal of Medicine, Kenneth Mandl and Isaac Kohane provide an insightful overview of personally controlled health records (PCHR) and their implications on health care delivery. Their article emphasizes in particular the impact PHCRs will have on the biomedical research enterprise. The authors discuss how the shift to consumer control will impact the very way researchers and the public view the process of studying health information. It is very similar in spirit to the disruptive potential of sites like PatientsLikeMe.com.

Every successful prototype throws more cold water on those who have not yet faced the obvious - information is not solely the property of the care delivery organization or payer intermediary - aside for certain stewardship and limited fiduciary purposes, personal health information should be under the management of the individual patient. The rules of the game are changing.
Mandl and Kohane have already authored significant works on public health infrastructure (JAMIA) and authentication (JAMIA, reference 37, PKI that "rings"). Kohane and Altmann have also published a wonderful article on the "health-information altruist" to be found in the New England Journal of Medicine ( 2005:53:2074-7).

What is new in the article released today? A few summary points:

There are two very signficant new constituents focusing on consumer empowerment and technologies to realize this empowerment. The first are the employers who are seeking efficiencies, improved health, and cost savings. The second are strong technology entrants like Google and Microsoft - each with comprehensive offerings capable of creating a more "seamless" digital relationship between an individual identity personal health information. (These two firms are attracting the most attention. WebMD, Intuit, and many other pioneers also have exciting offerings with great potential.)

What differs these new entrants from the established health IT vendors is their primary emphasis on the individual consumer. They aren't encumbered with a large provider-centric infrastructure model like those large firms who have made great technical and financial strides servicing hospitals, clinics, pharmacies, and health plans. Simply put, provider-centric reflexes and financial growth imperatives focus established vendors to refine offerings along established lines. As Clayton Christensen would put it, becoming a "disruptive" force is difficult when your earnings depend more on expanding your current strategic trajectory. Hence, many of these vendors are of necessity trying to build a better steam locomotive while hybrid autos and highways are appearing everywhere around the railroad tracks.

Mandl and Kohane emphasis that the shift in the locus of control of health information from provider to beneficiary will most directly impact daily care delivery, but their article focuses this general argument on the "threat" such technologies will have to academic medical centers and clinical research.

In their scenario, several challenging technical problems are raised.
  • First their individual must become authenticated and authorize subscriptions from providers and sources of clinical data (e.g., clinical labs, pharmacies, plans).
  • Second, they would authorize access views or even copies of records to providers, health care proxies, and possibly intelligent software agents that seek goods and services of value to the individual (e.g., disease management programs).

They describe PCHRs as a preview into a new era of "data liquidity" that will in turn updend traditional information information hegemony practices while fostering new markets for health care services. These new markets will open both to large new entrants like Microsoft and Google as well as to smaller and more regional innovators. The PCHR vision emphasizes a subscription model. Through its "hub and spoke" approach to personal consent and control, this model avoids many of the combinatoric complexities of inter-institutional data-sharing agreements and may legitimately circumvent some barriers imposed by differences among state privacy laws.

Although the basic architecture and principles behind a PCHR are relatively straightforward, some of the policies and complexities of course remain unsolved. The illustration in the Mandl and Kohane article describing the relationships among sources of health information and a centrally-controlled health record platform allows PCHR vendors to aggregate data across individuals and, barring policies and practices limiting use, provides the technical capability for these vendors to use group data against the intent of some who would retain their personal information in such systems. Explicit policies and rights along the lines of the Markle Foundation's Connecting for Health work will become essential to maintain public trust. Along the same lines, the authors note both use of de-identified data both in the HIPAA sense (which often really isn't de-identified the way you or I would like) as well as in the more mathematically sound way espoused by Sweeny, Malin, and others cited within the article.

No matter how you slice it, significant growth in PCHRs will significantly disrupt the traditional vision of exclusive institutional control often held by academic medical centers, health plans, and many other care delivery organizations. Business as usual, is over.

If one believes these new sources will provide valuable insights (and again, PatientsLikeMe.com is one possible test of this hypothesis), then the authors of this article are prescient when they say that "an entire generation of clinical researchers in training will find themselves with second-class or no access to the best research resources." Add to this problem the necessary growing reliance of academic medical centers on commercial health information systems that at times make clinical research technology modifications expensive. In response, the research community could take more more proactive approach to PCHR and for open-source systems devoted to clinical research and patient care.

The authors' treatment of certification and regulation is necessarily ambiguous. As an apocryphal quote goes: "it is difficult to make predictions, especially about the future." Mandl and Kohane rightly emphasize the importance of "guideposts such as a certification or a seal of approval with regard to services, software, and projects from a trusted authority."

This writer's problem: It is not clear those in charge of such certification efforts are certifying the right things. Emphasis should be first on clarifying CLIA and employer-individual privacy relationships. Some statement on data use limitations must be made since PCHR organizations are not HIPAA-covered entities. But does anyone think HIPAA is going to be fixed in the year before or after a national election such as this?

The authors identify a framework that in this writer's mind is very similar to the conundrum of the Treasury department looking at financial regulation. They speak of a "balance between patient control and a paternalistic protection against coercion and false claims made across the multiple channels of communication that are possible between these new...entities and...consumers." The speak of the urgent need for "creative and effective on-line consent processes."

They identify five hurdles:
  1. Standards
  2. Commitment of health care delivery organizations and others to publish to PCHRs
  3. CLIA revision
  4. Incorporation of information now only in paper form
  5. New approaches to identifying identity and trust

One conclusion is inescapable: the horse is out of the barn. Gradually, these many efforts will coalesce not into a standard "certified product" but perhaps at least a consensus on what is really important policy-making and what is a distraction. With this knowledge in hand, one can address the critical issues surrounding confidentiality, safety, and integrity.

The article is an inspiration. Give it a read!

Tuesday, April 15, 2008

Privacy and e-Prescribing

On April 14, 2008, a broad coalition of organizations sent a letter to Senator John Kerry and Representative Allyson Schwartz expressing strong support of their proposed electronic prescribing legislation - the Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007.

One suggestion bears particular note. Mindful of the broad public concern over privacy and confidentiality (and the appeals of a small group of privacy advocates that arguably excessively dominate Congressional hearings), the group argues for a systematic evaluation by GAO of prescription data use practices as a necessary part of any legislation.

Rather than focus on a particular technology, the organizations lending support seem to be pointing to a more extensive set of data sale and use practices already in place and often not included in the public debate.

This emphasis places needed attention not only on the future implications of a more comprehensive digital medication management framework but also on the current array of data use practices. Before one argues for more policy and legislation, this writer believes it would indeed be valuable for GAO to conduct this study - even if the E-MEDS bill does not advance.

Quoting from the letter to Senator Kerry and Representative Schwartz:

We believe that efforts to realize the safety and savings benefits of comprehensive health information technology (HIT) must move forward within a framework of privacy and security protections. For example, many consumers have concerns about the data mining of prescription drug information, and the success of efforts to promote widespread adoption of HIT ultimately will depend on the willingness of consumers to accept the technology.

In the absence of a national privacy and security framework for the exchange of health data, we feel strongly that obtaining more definitive information about how prescription data are currently being used is a key step to addressing privacy concerns. Thus, we strongly support including in any e-prescribing legislation a requirement that the General Accounting Office (GAO) investigate the prescription data mining industry and publish a report to Congress. The report should define clearly from whom data miners are getting data, whether it is fully de-identified, how easy it is to re-identify, what the policies/procedures are for ensuring that it is de-identified (or not re-identified), and to whom they are selling data.

[Selective use of bold font added for emphasis in this posting ]

The coalition includes:

  • AARP
  • American Federation of State, County, and Municipal Employees
  • Center for Medical Consumers
  • Childbirth Connection
  • Consumers Union
  • Health Care For All
  • National Consumers League
  • National Family Caregivers Association
  • National Partnership for Women & Families
  • SEIU
Read other related letters: