Premature Certification: Ready, Fire, Aim?

It may be harmful to certify prematurely what is not yet clearly understood.

It may be wasteful to deliver too many "top down" recommendations without being absolutely sure the certification body has both an understanding of and an appreciation for the complexity of issues and a respect for the professional societies, organizations, and other bodies who have been exploring (often for decades) issues underlying certification requirements.

The Certification Commission for Health Information Technology was developed in response to the HHS health information technology road map first released on July 21, 2004. The report described "private sector certification of health information technology products." The authors argued:

EHRs and even specific components such as decision support software are unique among clinical tools in that they do not need to meet minimal standards to be used to deliver care. To increase uptake of EHRs and reduce the risk of product implementation failure, the federal government is exploring ways to work with the private sector to develop minimal product standards for EHR functionality, interoperability, and security. A private sector ambulatory EHR certification task force is determining the feasibility of certification of EHR products based on functionality, security, and interoperability.

Phase one of the process was to focus on market institutions to foster adoption and did mention the relationship of EHR to health information exchange. The report stated:

Many of the agents and entities that are necessary for the health care industry to realize better value do not exist and must be developed and made operational before widespread change can occur. Certification organizations, group purchasing entities, and low-cost implementation support organizations are examples of market institutions that do not exist at this time, but which are necessary to support clinicians as they procure and use information technology. Likewise, although there are a variety of regional health information organizations, there is no consistent institution that can provide a platform through which financial investment or other support can be channeled to clinicians.

What began as a very clear and directed effort to reassure wary clinicians that health information technologies would meet clinical needs and could be acquired with minimal technical and financial risk has, arguably, devolved into a morass of overlapping and complex groups with great competence, sincere intention, and strong, balanced management.

Three years after the release of Secretary Thompson's report, much work needs to be done on fundamental issues widely perceived to be critical to progress. Examples include the ability to efficiently and securely deliver laboratory and prescription drug information to qualified providers at the point of care and need. Although there are early promising results, one wonders if the momentum on these critical areas has been stalled because of the barrage of meetings, use cases, demonstrations that do not release data, and an ever-changing set "priorities."

No one can question the talent and energy dedicated to - or the importance of - each and every one of these activities (how can you argue with drawing more attention to child health?), but increasingly, one gets the feeling of a technology debate landscape that is 10 miles broad and 1 inch deep. It is increasingly hard even to follow this work much less understand the priorities. It is increasingly difficult to see if the facts are even agreed upon. (The health information exchange discussion, for example, claims there are between 120 and 200 exchanges that - allegedly in the public interest - must be "certified"). This writer isn't sure there are a dozen functioning exchanges and questions whether or not certification is premature.

Here's a list of the working groups and their description

Ambulatory
The Ambulatory EHR Work Group develops criteria and test scripts for certifying electronic health record (EHR) products used in physician offices - large and small - where most Americans get their care.

Inpatient
Tasked with prioritizing and developing criteria and testing for Inpatient EHRs, the Inpatient EHR Work Group monitors the current need for health IT technology used in acute, hospital-based care.

Network
Interoperable EHRs require a structure for sharing information—a secure network. With the guidance of the Expert Panels, the Network Work Group is tasked with initiating the development of criteria and tests for these emerging health information exchanges.

Foundation
A core set of requirements underlie all EHR products and networks. The Foundation Work Group works with all other Certification Work Groups and Expert Panels, to propose the criteria and tests that belong to that core set.

Interoperability
Ensuring that EHR products and networks can share data compatibly is one of the primary goals of certification—and the public and private heath IT communities. The Interoperability Expert Panel works with all CCHIT Work Groups to recommend criteria and testing that ensures data portability.

Security
Charged with advising on the security requirements for CCHIT Certified EHRs and networks, the Security Expert Panel remains up-to-date on security standards and best practices to recommend criteria and testing for all EHRs and their networks.

Child Health
The care of children spans physician specialty practices and care settings. It's the role of the Child Health Expert Panel to ensure that EHR products and networks address the health IT requirements of caring for this special population by developing criteria and test scripts to be added to other certification categories as an option for certification.

Cardiovascular Medicine
The Cardiovascular Expert Panel has been tasked with recommending optional criteria and test scripts to other certification categories to address the unique needs of office-based cardiovascular physicians and practices with a goal of improving health IT adoption in that specialty medicine group.

Emergency Department
For this newly created certification category for a special care setting, the Emergency Department Work Group is charged with initiating the development of criteria and test scripts to certify EHR products used to support the treatment of Emergency Department patients.

Privacy & Compliance
To ensure patient confidentiality and regulatory concerns are addressed, the Privacy & Compliance Expert Panel is charged with recommending criteria and test scripts to all Work Groups for certification of EHRs and networks.

Building Nirvana Without Draining the Swamp

I have recently helped author and have reviewed a draft "blueprint" document from the eHealth Initiative. Concerns were raised that there was no consensus on two issues:

1. Alignment of incentives to compensate for adopting health care information technology
2. Policies for consumer engagement and information sharing.

To summarize for those who don't want to read my lengthy rambles, I can summarize:

• You cannot fix the HIT incentive problem given the complex and bewildering social network we call health care policy. To paraphrase Representative Jim Cooper's comments on partisanship in addressing the federal budget, trying to find the final answer to HIT incentives is "as foolish as a food fight on the Titanic." It will take time and adaptation to a skewed system. You cannot find the definitive HIT solution without arriving at a clearer consensus on the broader health care policy debate.
• You cannot find definitive issues on information sharing when the public is not informed on the current and fragile state of their privacy and when individuals are not held more accountable for their own health care expenses or lack a clear understanding of their social contract when third parties are asked to foot the bills. I am sure that if my daughters had the chance, they would take their credit card bills (which I usually pay) and argue that I should not be given access to their statements!

At greater length, there are two points:

Point 1: Incentives

It should come as no surprise that a consensus cannot be reached. Health information technology enables better health care delivery. The delivery of health care in turn is dictated by policy and compensation. When there is some consensus on policy and compensation, this should be reflected in how organizations pay for technology. I find it ludicrous that any business – be it a medical practice, a pharmacy, or a hardware store, should receive compensation from third parties for fundamental operational expenses. The trap is that we have enmeshed health care practices and providers (a.k.a. businesses) in extraordinary complexity and this drives up costs. My father - a manufacturer competing with China every day - would very much like similar compensation.

But there is something different between my father's circumstances and the plight of the health care delivery system. My father does not have to contend with a confusing array of Medicaid, Medicare, and health plans. My father doesn’t ship product and write it off as "uncompensated services." My father makes hydraulic pumps. These are not in the middle of any complex ethical and social debate concerning an obligation of a nation and individuals to care for the suffering. (His challenges - OSHA, trade policies, employee health care costs - are no less acute, but not directly relevant to this discussion.

ROI may not be the right question to ask - or certainly not the only question. For example:

• What is the ROI of a pediatrician?
• What is the ROI of an ophthalmologist?
• What is the ROI of a community pharmacy?
• What is the ROI for a critical access hospital?
• What is the ROI of a health plan?
  
• How should compensation be affected by geography, patient mix, need? We have a rather complicated fabric.
• Under the current model, is anything in our health care system “sustainable”? Anything at all??

My point isn’t that ROI is a futile area of inquiry, but only that these considerations are part of a broader set of values that place health care in a context more appropriate to its social mission.

This leads to a second issue with compensation. There are three types of actors here:

1. Those that actually pay. More often than not, this is government - more than we believe - because the tax deductions to employers represents a form of government subsidy. Read Jacob Hacker (http://greatriskshift.com/ ). The other payer - ask any uninsured individual or GM retiree - is the individual. That sort of makes sense (if one knew what the full cost and quality were). In my view (and a sentiment echoed by Craig Barrett of Intel) human resource managers and large employers have abrogated their responsibilities and have focused on short term cost controls (through plans, PBMs) at the expense of addressing a fundamentally broken and fragmented system.
2. Those who actually deliver services. This includes pharmacists, home health care, nursing home workers, physicians, disease management companies, and even families. These people incur expenses - be it in time, labor, or materials.
3. Those who are intermediaries trying to address supply and demand. These include health plans, pharmacy benefits managers, state agencies, Medicaid information technology vendors, and other groups. Some of these plans are sincerely trying to add value and improve value, but they are at arms length in many instances. There are others, I believe, who simply say "we got here first" and intend to keep as much of our health care dollars enmeshed in our current complexity since it often appears that the only way to make real money is to sit in the middle, encourage complexity, manage it, and hold onto as much money as one can. I do not call these organizations payers but rather intermediaries. To call an intermediary a payer and then complain that they have too much power is akin to claiming a bank “owns” my money. Intermediaries have money because the funds are not returned to those whose dollars pay for care and those whose efforts require compensation.

How can one possibly tease out health information technology and expect to understand how to pay for it without either assigning the burden to those whose primary business it is to deliver care or to raise the very important point that those who deliver care are placed in competition with one another? (Michael Porter is right: in health care we often compete over the wrong things)

By focusing on HIT as something peripheral to the broader health care debate, we only add to the crippling complexity and distract the public from the far more pressing issue of a bankrupt health care delivery system. If the value chain is skewed to allow intermediaries to hold onto excessive amounts of money, let's fix the value chain. If the system hides costs from the real payers - individuals seeking care and individuals paying taxes, let's fix that. Answer the right questions; fix the right problems; compete over the right things.

One can't come to a conclusive result on health care delivery until one develops a consensus. Until then, it is wise to work within the fragmented system and chip away where we can. It is rather foolish to even claim to fix the ROI problem for HIT without putting it in context of a larger and more confused health care system.

Point 2: Policies for Information Sharing (a.k.a. “You can't build Nirvana on a swamp”)

Recent interest in "medical information banks" and related ideas is in my mind one way people are coming to grips with the fact that their health information - and who has it - is associated with economic consequences to the subject of the information (the patient) and a vast array of other individuals who gain economic value either by disclosing individual information or aggregating information from disparate sources to gain a broader view of an individual, a provider, or a population.

There are a few realities we "consumers" have to face:

• We don't pay all of our own bills - others do. These other parties therefore have some rights to see what they are paying for (much as I want to see the credit card bills I pay for my daughters).
• There is an inevitable tension between the needs of providers and the desires and regrets of the individual receiving care. There are similar tensions among all of the groups of providers, consumers, and intermediaries. The only way out of this is to examine - carefully and over the course of years - the realities of our concerns. For example, how often does "not knowing everything" harm care? There is nothing like building an actual operational health information chain to focus on the important, short-term issues.
• Because we run up a lot of expenses - either because we have no price sensitivity or because we are in dire need of services to care for our chronic and acute care - intermediaries who profit from retaining funds naturally understand that excluding the high-cost individuals helps the bottom line in most instances. This doesn’t mean organizations take active measures to exclude such individuals, but it is reasonable to be suspicious of impersonal organizations who profit at the expense of excluding individuals or groups
• We "consumers" in general don't have a clear understanding on how confusing and porous our current system is, and our so-called "consumer advocates" rarely speak up on that topic, focusing instead on the much more high-profile issue of HIT and exchange. Do "consumers" understand their health care information is kept in data warehouses, sold to pharmacy detailers, and their paper records disclosed to callers and individuals without clear authentication, authorization, or transparent policy? I have often wondered where our leading consumer advocates are when we look at the status quo. Instead of tackling the difficult challenges associated with paper-based records, access, use, and audit trails, advocates tend to migrate to the much "cooler" digital environment and try to create an ideal system in what is at present a confusing and very messy world of paper.

Trying to revolutionize totally health information technology and consumer information rights absent of a consensus for broader health care policy issues is like trying to build Nirvana in a swamp. In my view, it is better to have some consensus on how to drain the swamp before talking about what Nirvana "should" or "must" be like. This is the conundrum of AHIC and teh NHIN II proposals. It's hard to move forward in the absenc of broader consensus on how 16% of our Nation's GDP should be managed. Personally, I am not sure all engaged in federal efforts or laboring on the campaign trail understand this critical point, since in the abstract Nirvana is more attractive to voters than dry land and rhetoric far more fungible than actual results.

The eHealth Initiative Blueprint draft does a god job of identifying the areas of concern. The more I think of it, the more I think we are building a very good blueprint – a part of a broad fabric of such efforts across a spectrum of organizations. But one cannot be expected to have an answer to these questions any more than the the originators of hypertext (e.g., Doug Engelbart), the creators of the internet, Alexander Graham Bell, or the first individual to send an email could have anticipated what emerges.

What is important is framing the questions right. And in this regard, the course of technology advancement at least sometimes follows ones vision for the future. (In other instances, it refines or even re-directs this future.)

Since we do not have a clear vision of the costs, the quality, or the mechanisms for addressing our critical health care delivery challenge and since we don’t have a clear consensus on the conflicts between the rights and responsibilities of the individual and those of society, we should not be concerned; we should not make excuses. No number of planning or discussion phases will "solve" these problems, but only advance our collective understanding much as our democracy was not designed by the Founding Fathers as a road map in three phases: planning, implementation, evaluation. Arguably, the debate about health care in America is very much a debate on our vision of what a democracy should be.

Our major challenge is to ask the right questions. If we ask the wrong questions, we are less likely to get the answers that make a difference.

Health Care Costs..Unspoken, Ignored

It is hard to balance the current controversy over SCHIP with the broader and looming catastrophe of rising health care costs for the general population. Intel's CEO, Craig Barrett summarized this broader question in his September, 26 speech to the eHealth Initiative. In it he said:

If you look at the annual health care cost increase compared to a couple of other metrics, the War in Iraq, and basically the average cost increase to the economy due to petroleum price increase, you see that health care spending in the U.S. is 2X those other two topics.

This conservative and pragmatic approach has been echoed across the political spectrum. Consider two recent editorials in the New York Times. The most recent was a response to the recent attempt by General Motors and the United Auto Workers to reach a compromise on this vexing problem. An editorial from less than two weeks earlier addressed the positions of the political candidates on health care

NY Times
G.M.’s Health Care Fix
Published: October 7, 2007

Unfortunately, this deal does nothing to restrain the underlying escalation of medical costs driving the problem. It simply shifts responsibility for administering insurance coverage from the company to the trust. Some experts hope that the union, once it is in charge of health coverage, will eventually restructure its benefit package to give retirees an incentive to economize on care. The trick would be to reduce waste and overuse without curtailing needed services.

NY Times
EDITORIAL; The Battle Over Health Care
Published: September 23, 2007

What's Missing
All of the plans, both Republican and Democratic, fail to provide a plausible solution to the problem that has driven health care reform to the fore as a political issue: the inexorably rising costs that drive up insurance rates and force employers to cut back on coverage or charge higher premiums. All of the plans acknowledge the need to restrain costs, but most of the remedies they offer are not likely to do much.

Electronic medical records to eliminate errors and increase efficiency, more preventive care to head off serious diseases, and better coordination of patients suffering multiple, chronic illnesses are all worthy proposals, but there is scant evidence they will reduce costs. Proposals to import drugs from abroad, allow Medicare to negotiate drug prices, restrain malpractice expenses, increase competition among health plans, and empower consumers to shop more wisely for medical care might help a bit. But many experts doubt that any of this will truly put the brakes on escalating health care costs.

No top candidate in either party has broached more drastic remedies, like limiting the use of expensive new technologies, cutting reimbursements to doctors and hospitals, or forcing people to use health maintenance organizations. And no one has suggested imposing higher taxes on everyone, not just the wealthy, to finance universal coverage. These solutions are not even discussed on the campaign trail lest they alienate voters and interest groups.Who will act?

What is to be done?

Part of the challenge lies in an honest assessment of the enormity of the challenge. In this regard, Representative Jim Cooper - a champion of transparency - has offered a plan before the House entitled "Securing America's Future Economy Commission (SAFE) Act." According to a recent article in the [Nashville] Tennessean, this act "would establish a 16-member bipartisan commission that would propose legislation to deal with the shortfall for social programs, the high level of foreign investment in the U.S. and other fiscal issues.
Legislation offered by the commission could only be voted up or down by Congress without any changes. This approach has been used successfully to deal with the closing of U.S. military bases."

"'Partisanship on this issue is as foolish as a food fight on the Titanic,' said Cooper, a Nashville Democrat who was joined by co-sponsor Republican Rep. Frank Wolf of Virginia. Eleven House members, including Rep. Lincoln Davis, D-Pall Mall, are original co-sponsors of the legislation."

A second and equally vital component is to add elevate awareness of these costs to those who are incurring costs beyond our means - in other words, all of us alive today. In a sense, we are passing on our irresolution and denial to future generations. Short of an economic catastrophe or widespread social unrest from internal or external events, Americans seem to learn their lessons the hard way.

This brings us full-circle to the present approach to health care.

Let's look at what the President has said about the uninsured in a July 10 visit to Cleveland, Ohio:

Let me talk about health care, since it's fresh on my mind. The objective has got to be to make sure America is the best place in the world to get health care, that we're the most innovative country, that we encourage doctors to stay in practice, that we are robust in the funding of research, and that patients get good, quality care at a reasonable cost.

The immediate goal is to make sure there are more people on private insurance plans. I mean, people have access to health care in America. After all, you just go to an emergency room. The question is, will we be wise about how we pay for health care. I believe the best way to do so is to enable more people to have private insurance. And the reason I emphasize private insurance, the best health care plan -- the best health care policy is one that emphasizes private health. In other words, the opposite of that would be government control of health care.

And there's a debate in Washington, D.C. over this. It's going to be manifested here shortly by whether or not we ought to expand what's called S-CHIP. S-CHIP is a program designed to help poor children get insurance. I'm for it. It came in when I was the governor of Texas; I supported that. But now there are plans to expand S-CHIP to include families -- some proposals are families making up to $80,000 a year. In other words, the program is going beyond the initial intent of helping poor children. It's now aiming at encouraging more people to get on government health care. That's what that is. It's a way to encourage people to transfer from the private sector to government health care plans.

My position is, we ought to help the poor -- and we do, through Medicaid. My position is, we ought to have a modern medical system for the seniors -- and we do, through Medicare. But I strongly object to the government providing incentives for people to leave private medicine, private health care to the public sector. And I think it's wrong and I think it's a mistake. And therefore, I will resist Congress's attempt -- (applause) -- I'll resist Congress's attempt to federalize medicine.

I mean, think of it this way: They're going to increase the number of folks eligible through S-CHIP; some want to lower the age for Medicare. And then all of a sudden, you begin to see a -- I wouldn't call it a plot, just a strategy -- (laughter) -- to get more people to be a part of a federalization of health care. In my judgment, that would be -- it would lead to not better medicine, but worse medicine. It would lead to not more innovation, but less innovation.

Read the full text of an October 2 White House press briefing by Dana Perino (Iraq War Tax and S-CHIP). The remarks from this conference - notably about the cost of war and the propensity for one party to support taxation, have been widely circulated by Thomas Friedman and other columnists of a range of persuasions.

MS. PERINO: Well, we've always known that Democrats seem to revert to type and they are willing to raise taxes on just about anything. There's no need to increase taxes. The President has shown how if we prioritize and if we get the spending bills done in a clean way, we can actually have a surplus in our budget by 2012. We don't see any need to raise the taxes.
Q But when you talk about priorities, tomorrow we're expecting the President is going to veto the S-CHIP bill over saving $30 billion, and meanwhile you're spending hundreds of billions of dollars in the war in Iraq --
MS. PERINO: But the President -- the President's first and foremost responsibility is making sure that Americans are safe, including children are safe. And, frankly, that's Congress's main responsibility, as well. And that's where the priorities are. I think that anyone -- I think it's apples and oranges to try to compare S-CHIP to funding for the troops.
Q Well, they're all in the same federal budget, you do have to pick priorities on what you're spending money on, don't you?
.....
A .....when you start digging deeper and realize that they've got a funding cliff, that basically in 2011, there's no money left for the S-CHIP program. They don't fund it sustainably. And on this idea of raising taxes on the American people right now to fund a war, well, does that sunset? Do they wait for al Qaeda to wave a white flag and then those taxes are going to go away? Does anyone seriously believe that the Democrats are going to end these new taxes that they're asking the American people to pay at a time when it's not necessary to pay them? I just think it's completely fiscally irresponsible, and the President won't go along with it.

The issues are not partisan; the issues are not potentially as polarizing as partisans would have one believe. The primary challenge is simple: how do we as a society elevate awareness of these pressing issues and employ every ounce of our entrepreneurial energy to rebuilding a national infrastructure that includes better health care, better education, and a safer, stronger beacon of liberty? What is required first and foremost is a more honest attempt to focus on the problem, not anticipate fixing the blame.

Tennessee eHealth Council Releases Summary of State Laws Influencing eHealth

In a communication to the eHealth Council, Mr. Antoine Agassi today announced the release of an extensive review of state law influencing the exchange of health information. This work - conducted by Randy Sermons under state contract - parallels similar efforts funded through the Office of the Network Coordinator last year. It was reviewed extensively by parties throughout the state.

The summary is the PDF output of an internal database created in the course of this analysis.

• Follow this link for the PDF summary