Grassroots

Farzad Mostashari and I wrote a short white paper urging a more direct link between Federal HIT incentive funds and regional HIT extension centers (Farzad deserves the lion's share of credit for taking this idea and running with it). Pretty straight-forward idea, really -- rather than just handing out $18 billion in cash to providers, funnel those funds through an infrastructure that will protect the government's investment by ensuring that adoption happens efficiently, effectively, and with public benefit in mind. You'd think this would be a no-brainer after our recent experience with the $350 billion bank give-away, but so far, the concept hasn't made it's way into the stimulus package.

The letter has gotten almost 60 signatures from individuals and groups across 26 states, including some prominent national organizations such as the eHealth Initiative, NCQA, National Partnership for Women & Families, and Pacific Business Group on Health. It's also gotten a fair amount of attention. It was featured on iHealthBeat, John Halamka wrote about it in his blog, and it was also picked up by the New York Times. Thanks to everyone who co-signed it......hopefully somebody up there is listening!

Piety in the House of Representatives

The House versions of the economic stimulus related to health IT are working their way through the Ways & Means and Energy and Commerce Committees. Then, it's on to the Senate. The House bills delay release of 90% of HIT funds until 2011, ostensibly on the grounds that the technology isn't ready for immediate investment. Paradoxically, the House approach works only if physicians start investing in systems right away, and it completely ignores the reality that the problem isn't the technology, it's the lack of a business imperative. The very same technology that they criticize is now expected to solve the mind-numbing flaws that currently plague our health care delivery system.

The House approach takes $20B and gives $2B to a government agency now, and $18B to physicians in the form of phased incentives starting in 2011. However, in order to get these incentives, physicians have to be already using these EHRs and HIE in "meaningful" ways (ie, electronical clinical quality reporting and care coordination) by 2011. Which would mean that for most physicians, they would need to start implementing within the next 18 months, because it takes that long to get up and running on these systems.

In taking this approach, the legislation assumes that each physician will make a roughly $50K investment now on the promise of being repaid for this by Medicare over a period of 5 years beginning in 2011. Assuming, of course, that they can pass Medicare's test on "meaningful" use, even though that hasn't been defined and at present there's little to no infrastructure to allow such meaningful use anyway.

Seems like a tough sell to me. There are very very few places in the country that have regional health information networks, and there are no places that have real infrastructure for electronic reporting of clinical quality data, so Medicare will have a hard time defining what meaningful use is, let alone certifying that physicians have successfully done it. They already tried to launch electronic quality reporting a few years ago in the DOQ-IT program, and it was an unmitigated disaster.

Then there's the problem of implementation. According to Medicare, 30-40% of EHR implementations fail. And the vast majority of the ones that don't fail aren't implemented to inter-operate with other systems or generate good clinical quality data.

The House approach glosses all of this over, however. It underinvests in a technological and organizational infrastructure to guide this massive makeover of 15% of our economy, and overinvests in a misplaced faith that IOUs to physicians will drive individual purchases of EHRs, and this, in turn, will induce demand for the network and implementation infrastructure needed for success. And according to success criteria that we're unable to define at present. And in time to meet the President's goal of ubiquitious adoption by 2014.

It reveals an almost religious belief in the power of incentives, however diffuse, and technology, however complicated, and markets, however dysfunctional, to solve the problems that have left 96% of physicians without a fully functional EHR up until now. Almost touching, really, this kind of faith, misplaced though it may be.

Message to Congress: It takes a village to implement an EHR

Well, the health IT legislation is starting to take shape, and it's a little more sobering than the initial speculations of tens of billions of HIT dollars being unleashed on state governments in the next few months. In many ways the recent turn of events is an about-face from the early speculations. The House Appropriations and House Ways & Means Committees approaches have the following policy underpinnings:

1. Separates HIT spending from the economic stimulus
2. Focuses first on creating a framework for how to handle billions of dollars of HIT funding
3. Drives the vast majority of money (90%) through Medicare/Medicaid reimbursement channels
4. Focuses the role of state governments on areas that require local coordination, tailoring, and governance
5. Moves ONC beyond "coordinator" to actual owner of administrative infrastructure, with all of the programmatic and fiduciary responsibilities that such functions imply
6. Makes the Federal government the decision-maker on issues such as technical standards, with input from advisory committees on policy and HIT

I'll admit that I was among those who was getting a little dreamy and even woozy at the thought of billions of dollars flowing into health IT over the next year. Compared to that somewhat heady vision, the House language is surely a disappointment. Yet, like most compromises, it represents progress in certain key areas.

Things I like about the approach are:

• Balance of state-led and federally-led approaches. I like the idea of a network of regional HIT Extension Centers that work directly with ONC rather than through states. State governments have a role as well, but mostly in the areas of coordination, galvanizing health information exchange, promoting quality improvement and public health, and making sure that under-served communities don't get left behind. I like this approach because EHR adoption is not nearly as state- or local-specific as is HIE, which really does need to be tailored to local markets and conditions. Thus, it makes sense to let the Feds drive EHR adoption through regional organizations, and have states focus on state- and local-level HIE concerns.
• Incentives for doing stuff, not just for buying stuff. Focus on incentives that require participants to use the technology, rather than just having systems that are "certified". I like that the incentives are tied to quality reporting and health information exchange because I don't believe that inter-operability standards are enforceable without having activing monitoring by certified HIEs, public health entities, and quality data aggregation entities.
• Resources and authority to ONC to get on with it. Gives the clear message that the federal government has to take a stand on key policy decisions in order for us to move forward. This is not ideal, particularly for standards in a fast-moving, decentralized technology space, but it's not clear to me that other approaches are obviously better. The Federal government needs to set standards for Medicare and Medicaid, so that much makes sense regardless of how standards get determined generally.

Things that I think would improve the House language are:

• Develop a programmatic overlay to the EHR implementations. Inter-operability and robust reporting don't just happen, they get done. And they won't get done if there isn't an implementation program behind the effort, because the systems are too complicated for individual physicians to do this on their own. There's also too much coordination required with other entities, which can only be coordinated by a formalized program. Therefore, we should cement the link between EHR incentives and the HIT Extension Centers. EHR implementations should be executed through or certified by the HIT Extension Centers, otherwise we'll end up with a lot of really bad retail implementations, just like we have today, because we'll only find out about them ex post (ie, after they've failed and can't deliver on their quality and HIE requirements).
• More HIT funding should be made available before 2011. Not necessarily the whole $18B, but there are some parts of the country that are ready to meet the new requirements right away, and we should make funds available to them to build on their momentum while the overall program catches up.
• We should try to go "wholesale" rather than "retail". The current approach to the incentives is to go "retail", meaning physician-by-physician, but there's much more value to be had by going "wholesale", meaning market-by-market. Retail implementations will only mimic, or worse, amplify, the existing entropy of care delivery. Putting a programmatic overlay to "communities" or "markets", such as New York and Massachusetts are doing, creates more effective and efficient vehicles for getting providers to work together, which they do too little of today, and ease the path for them to focus on how to best use technology to improve care across the system, not just in their individual offices.

So, concrete ways to accomplish these goals might be:

• Designate a couple of HIT Extension Centers right away
• Formalize the role of HIT Extension Centers so we get more proactive interventions in government-funded EHR implementations to get better assurance that they get done right the first time, rather than trying to rescue them after they've failed
• Provide additional funding to these HIT Extension Centers for them to provide implementation services to physicians up-front
• Accelerate Medicare and Medicaid incentives to the markets that these HIT Extension Centers cover
• Allow aggregation of incentives by community according to a formula that allows providers who share the same patients to implement in a coordinated way, and perhaps provide a "sweetener" to those who organize themselves this way

One thing we should recognize is that by putting most of this into Medicare/Medicaid incentives, and by delaying most of the money until 2011, HIT could be on a collision course with health care reform. In some ways that's good, because we shouldn't be using technology to try to solve the intractable problems of the current system, we should use technology to enable and enhance a better system. Yet, the reality is that we could get to a point where we push off the 2011 date to align it with health care reform. That would get us even further away from the President-elect's goal of ubiquitious EHRs by 2014.

Ready for prime-time

The New Year’s Day issue of the Boston Globe had an article discussing some objections by people concerned that HIT systems aren’t ready for the large-scale investments being advanced as part of the economic stimulus package (“Letter highlights hurdles in digitizing health records”). The critics advocate investing at a slower pace and focusing investments not on purchasing current technologies but on creating new technologies to fix perceived shortcomings in current systems.

I understand the concerns – after all, we’re talking about spending billions of hard-earned taxpayer dollars, and as a citizen and former federal government employee, I see that as a sacred trust. From what I’ve seen though, these concerns are either misplaced or readily addressable and therefore don’t warrant delaying large-scale investment.

It is certainly true that current EHR systems are complicated, cumbersome, and barely inter-operable. They are that way for a reason: US health care delivery is complicated, cumbersome, and barely inter-operable.

The supply-side of health care is unbelievably fragmented. According to the AMA, there are about 670K practicing physicians in the US. Roughly 150K of them are hospital-based and practice in 7500 hospitals, two-thirds of which are community hospitals. The other 520K physicians work on the ambulatory side and, according to the CDC, they are spread across 170K office-based practices nationwide, 80% of which are solo or 2-physician practices. This is a cottage industry where the individual businesses face little market pressure to standardize around anything except billing codes. Not surprisingly, when they purchase technology, they don’t demand standardization either, and indeed, they demand the opposite, namely, that the technology be able to adapt to their non-standardized and idiosyncratic workflows and clinical decision-making processes.

This fragmentation among so many small and independent providers has three negative effects on health care delivery that federal HIT funding can help resolve. First, care is difficult to coordinate. Second, basic reporting for public health and performance measurement does not exist. And third, clinical documentation and data standards are impossible to promulgate and enforce. Federal HIT funding can help overcome these obstacles by giving all users the tools to document and communicate key information according to national standards, and requiring that they do so as a standard of care.

Getting back to the main point then, the critics have it all wrong. We shouldn’t be waiting for better technology, because technology is an ever-moving target driven by technical and scientific improvement and user demand. If we had insisted that Tim Berners-Lee anticipate live streaming of HD video from the likes of YouTube and Netflix, we’d still be waiting for the World Wide Web. Nor should we be spending a lot on “innovation” or “simpler, easier” technologies, because we’ll almost assuredly get that wrong. Governmentally-directed innovation spending would never have come up with Google, Twitter, Facebook, YouTube, Hulu, Yelp, Sermo, and craigslist, and we’d be much worse off for it.

So, government funding is needed, but spent the wrong way it can stifle innovation and just plain waste a lot of money. What we need to do is first recognize that this will take a long time to get right, it’s wrong to try to architect it perfectly in advance, and it will only become mature when more users engage in using technology to accomplish real business needs. With such a decentralized user base, fast-moving technology, and a dynamic, complicated field such as medicine, we should specify as little as we can get away with technologically but create a flexible architecture that can efficiently accommodate changes into the future. New York is working on just such a model.

EHR technology has gotten as far as it can in a thin market – what’s needed now is more bottom-up pressure from more users, and more top-down pressure from policy-makers and businesses to align these users. Federal dollars can facilitate this by creating a large user base and imposing a policy and programmatic overlay to what would otherwise be a funding free-for-all.

My personal recommendations for an economic stimulus funding program would be:

• Establish goals focused not on technology, but on what we want people to do with technology, such as coordination of care, adherance to guidelines, reduction of medical errors, and improvement of population health
• Each state should designate an HIE entity (or entities) to broker and enforce statewide health data exchange, and make Medicare and Medicaid data available to authorized users through this HIE infrastructure
• Require that all clinical entities use the state-designated HIEs to provide patient-specific post-visit reports to each other
• Require that all clinical entities use the state-designated HIEs to regularly report public health and quality/safety data to state-designated public health and quality data entities
• Require that all clinical entities use the state-designated HIEs to populate patient health records (PHRs)
• 90% of funding be earmarked for EHRs, and 10% for state-designated HIEs, quality data warehouses, and public health reporting infrastructure
• Require that state-designated HIE, public health, and quality data entities monitor and enforce health data exchange according to existing HITSP standards for data exchange and existing quality and safety measurement standards established by AQA, NQF, HITSP, and others, and penalize states that don’t do this

Is it scary to spend so much taxpayer money so fast? You betcha. But that’s true for every part of the economic stimulus package, not just health care. The need is great, however, so we need to roll up our sleeves and put in place the right vision, leadership, and management. The health IT infrastructure and experience base is perfectly poised to make excellent use of such funds to accomplish the goals of immediate economic stimulus and improvement in health care. By outfitting physicians with modern tools, and requiring that they use them to achieve societal goals, our federal stimulus dollars will provide returns to the country for years to come.

What is the federal approach to privacy and HIT?

While I was away on vacation last week, HealthcareITNews published the following: "Federal privacy panel leader resigns, raps standards". It describes how privacy expert and advocate, Paul Feldman, has resigned his position as co-chair of the Confidentiality, Privacy, and Security Workgroup of the American Health Information Community (AHIC).

For those of you who don't know, AHIC is an advisory group -- chaired by HHS Secretary Mike Leavitt -- that is supposed to make recommendations to the federal government on how to accelerate HIT adoption. Since 9 out of its 18 members are federal or state government employees, I'm not sure how much of a "community" it really is, but that aside, it's chaired by the Secretary himself so it's clearly important. (Then again, since the government is responsible for 2/3 of all health care spending in the US, maybe the government is under-represented on this panel. And maybe we should more seriously consider a single-payer model since we're almost there anyway. But I digress.....)

It's hard to know from the outside what's really behind public resignations of this type, but the very fact that it's happened is not good. Feldman's letter of resignation cites the following:

We have determined we are unable to continue given that the workgroup has not made substantial progress towards the development of comprehensive privacy and security policies that must be at the core of a nationwide health information network (NHIN)...We support the development of an NHIN with strong and enforceable privacy and security rules in place and believe that the failure to achieve a privacy framework acts as a significant barrier to a robust and secure environment for e-health.

It would be one thing if this was an isolated incident. Unfortunately, it comes on the heels of a GAO report whose title says it all: "Health Information Technology: Early Efforts Initiated but Comprehensive Privacy Approach Needed for National Strategy". And last summer, the National Committee on Vital Health Statistics issued a report with similar findings.

While I wouldn't say this is much ado about nothing, I do think it's much ado about the wrong thing. Both Feldman and the GAO focus on the need for standards for a national network, citing President Bush's goal of having this in place by 2014.

As interesting as that discussion might be, I don't think an interoperable national network is going to happen by 2024, let alone 2014. Indeed, we don't even know what we should argue about because we don't know what such a network would look like, let alone when it would be created. For example, if the only justification for a national network is to aggregate deidentified data for population health measurement, there are a whole host of issues that we don't have to argue about. Worrying about too many of these details now is like fretting over relocation policies for coastal communities displaced by rising seas from global warming -- let's worry about it if the time comes.

Where we should focus attention is on where the action is: state- and local-networks. Many such networks will be up and running in the next few years (including three MAeHC networks before the end of this year). Yet, there is tremendous variation in state privacy policies at present. For many states, HIPAA is the binding constraint. For others, like Massachusetts, state privacy standards are much higher.

Anyone putting systems in place right now is basically making up a whole bunch of stuff as they go (with varying degrees of diligence). They're doing this because they have to. Federal and state laws aren't nearly clear or detailed or coherent enough, lessons learned in one state don't always translate to other states, and the urgency to get systems in place won't wait for the law to catch up.

Yet, the question remains, shouldn't a citizen of Louisiana or Ohio expect to have the same basic privacy protections as a citizen of New York or Massachusetts? That question won't be answered by setting policies for a national network that may never be built -- rather, it requires discussion of how to regulate state- and local-networks that are already being built, and in particular, on whether HIPAA and other federal privacy statutes and regulations provide an adequate floor of privacy protections for such networks.

The federally-sponsored Health Information Security and Privacy Collaborative (HISPC) is currently doing an inventory of state-level privacy policies, which is a necessary step in the right direction. (The MA-HISPC project is doing this work for Massachusetts.) The first results from this work are going to be presented in Washington on March 5-6. Whether this work is progressing nearly fast enough to address what's already happening on the ground remains to be seen.......

Privacy rules

Sunday's NYT article touched on so many issues it was hard to address them at one sitting. The article asserts that concerns about privacy and security are the major obstacle blocking passage of pending bills on health IT. I wish that was true because it would mean that privacy concerns had become a higher priority than they have been up until now, and that there was agreement on all of other vexing issues in this area. Alas, I don’t think either is true.

Privacy and security are clearly important considerations on lawmakers’ minds, but equally if not more important barriers are:

1. lack of budget
2. blurry policy options, stemming from the complexity of health care delivery and little to no understanding at the federal level of the complexity of these issues
3. disagreement (mostly ideological) on the role of government generally, and the divvying up of power between federal- and state-levels specifically
4. lack of awareness among the public (or more specifically, voters) of the urgency of taking steps to improve the quality and efficiency of our care

The following commentary from iHealthBeat is indicative:

"Prospects look pretty good" for the 110th Congress to pass health IT legislation in 2007, Michael Zamore, a policy adviser for Rep. Patrick Kennedy (D-R.I.), said in an interview for an iHealthBeat special audio report. According to Zamore, health IT is a "great candidate" for bipartisan efforts because "it's teed up, it's kind of ripe, it's been kicked around, it's had a false start or two," and the "ideas have been percolating and vetted.

"David Merritt, project director at the Center for Health Transformation, said the opportunity still exists to pass a bipartisan conference bill during the 109th Congress' lame-duck session codifying the Office of the National Coordinator for Health IT and allowing hospitals anti-kickback exemptions to provide physicians with health IT equipment.

"Let's not throw away all the progress we've made up to this point simply because of the change in power," Merritt said. However, Zamore and Merritt agree that identifying funding for health IT initiatives with current budget deficits will be a challenge (Rebillot, iHealthBeat, 11/15).

The Democrats on the Hill (especially Ed Markey) do place a greater emphasis on privacy concerns than do the Republicans (outgoing Connecticut Republican Congresswoman Nancy Johnson's bill was silent on the issue, for example), so maybe this will rise in importance in the new Congress. In this environment though, I think cash (or lack thereof) will still be king......