HealthBlawg

The FDA Patient Network Website - Pretty Darn Patient-Centered

The FDA launched an impressive patient network website this month, after nearly four years of research, focus groups, usability testing and more. The twin goals for this website are promoting the educational mission of the FDA, and promoting opportunities for patient advocacy within the FDA — and earlier in the policymaking process than has been the case historically. James Valentine, Program Analyst in the Office for Health and Constituent Affairs put it simply and forcefully in a recent telephone conversation: “The idea is to engage the patient community, to have the patient voice heard at the FDA.”

Historically, the agency has been working with patients one-on-one, by phone and email, often when an extremely ill patient is seeking information on clinical trials or access to investigational products. The goal is to broaden the field of engagement. The agency has had patient representatives on its advisory committees since the late 1980s — an innovation that came about as part of the response to AIDS/HIV — and patient involvement in the FDA’s processes were further formalized in the late 1990s, as part of Clinton-era cancer initiatives. There are now about two hundred patient representatives involved in over 110 disease areas.

The FDA Safety & Innovation Act (enacted in mid-2012) mandates the involvement of patient representatives in roles beyond those of the advisory committees. Draft procedures for patient involvement are due to be made public in September of this year, according to Valentine. Unlike opportunities for patient involvement in other government agencies, the FDA recognizes patient representatives on advisory committees (and in the new roles) as consultants — just as scientific and clinical experts brought into the FDA process are recognized as consultants — and this means that patients involved in the FDA processes in an official capacity are paid for their time and expenses.

Aside from this new program, the website really just puts a patient-friendly face on an existing set of resources — clinical trials, investigational products, and more — but the improvement is quite welcome.

While the new website is a gateway to the FDA, Valentine assures us that “the Office of Health and Constituent Affairs is still here to help patients navigate the agency.”

The first FDA Patient Network live chat will be a town hall meeting with staff from the Office of Health and Constituent Affairs on May 21 at 3:00 p.m. EDT. Future chats will feature staff from throughout the agency.

Here’s hoping that the FDA will carry through on the promise of online openness.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 

A version of this post first appeared on e-patients.net, the blog of The Society for Participatory Medicine.

Rural health white paper released by UnitedHealth Group think tank

The UnitedHealth Center for Health Reform and Modernization released a white paper today on Modernizing Rural Health Care.  To quote from the UHG presser,

• [The paper] projects an increase of around 5 million newly insured rural residents by 2019 – even as the number of physicians in rural America lags
• Quality of care is rated lower in rural areas in 7 out of every 10 health care markets; both physicians and consumers in rural areas more likely to rate quality of care lower than those in urban and suburban markets
• Innovations in care delivery – particularly telemedicine and telehealth – can absorb future strain on rural health care systems

The paper inventories the current state of health care for the 50 million Americans living in a rural setting -- and it's not pretty.  The question, of course, is why does rural health compare unfavorably to urban health metrics, and what can be done to improve matters?

The answers proffered are not particularly surprising.  Access to primary care providers and specialists is limited in the rural setting, it's likely to get worse, and the workarounds we've tried to put in place -- everything from clinicians "riding circuit" to telemedicine -- need to be implemented more broadly and need to be supplemented by additional resources. 

The resources needed include nurse practitioners, for example, whose hands are tied by restrictive scope of practice rules in heavily rural Southern states, and guidelines that could make them more effective primary care providers in an era of physician shortages; conversions of existing rural health care facilities to more current, relevant, uses. 

The resources needed also include dollars -- lots of cold, hard, cash -- to support this workforce, these guidelines, these facilities, needed collaborations with urban providers, and to bootstrap telemedicine beyond its current use, primarily for imaging, to expanded uses that can fulfill the promise seen in studies of pilot projects: quicker diagnoses, avoided costs, better outcomes.  Changes in telemedicine rules are also needed, e.g., relaxation of local licensing and credentialing requirements, so that rural access to telemedicine is not unreasonably limited.

In sum, I see the bottom line as, well, the bottom line.  An unspecified amount of money -- in the form of price supports and funding for other system supports -- will be needed in order to realize the promise of successful pilot programs in rural health. 

If we can learn from history (so that we may not be doomed to repeat it), we must remember that price supports can have unintended consequences.  For example, the federales can point to a great success in the form of the Department of Agriculture's extension centers -- the ONC's RECs are modeled on them -- but the danger to keep in mind when thinking about that model is that a couple of generations later the productivity of family farms, which was at first changed for the better, accelerated out of control thanks to continued meddling by the feds.  Consolidation of properties into factory farms was encouraged, resulting in a monoculture which has done irreparable harm to the environment.  I am not suggesting that enhanced Medicaid funding under the ACA for rural health improvement will lead to ruin, just that we need to always remain cognizant of the effect that pushing on one side of the balloon may have on the other.

Furthermore, one of the key lessons of the experience to date seems to be that programs arghmust be tailored to local conditions and cultural expectations in order to work well.  Thus, while a handful of inspiring program examples are offered -- drawn from rural Wisconsin to the Navajo Nation -- developing a comprehensive set of solutions addressing the issues presented in this paper will not be easy. 

All in all, we may have an understanding of what needs to be accomplished, but it is less clear just how to do it, and how to pay for it.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Healthcare Associated Infections: What is the Message, and What Can We Do About Them?

 

The good people at GE and JESS3 have come up with an HAI infographic.  It's pretty, and it conveys the horrible information that many of us already know -- healthcare associated infections kill about 100,000 people a year, and add $35 billion a year to our collective health care bill (here in the US of A); 5% of hospital inpatients end up with an HAI.

So what do we expect the world to do with this infographic?  The FDA has rolled out new cigarette package warnings, including graphic photos, that are presumably intended to so sicken potential purchasers of cigarettes that they drop the pack of cigarettes and run screaming from the counter.  In more measured terms, the FDA says:

The introduction of these warnings is expected to have a significant public health impact by decreasing the number of smokers, resulting in lives saved, increased life expectancy, and lower medical costs.

But what is the expected public health impact of publishing this infographic?  I would like to see GE, and/or others, fund the public health campaigns that are needed to accompany the release of such information.  GE is already doing some of that, to be sure, but a staggeringly large problem like the one identified here needs more attention.  The federales are trying to move the needle by refusing to pay for the cost of providing health care services required due to HAIs.  The government and providers are likely to be spending a lot of time and resources in line-drawing and finger-pointing, fighting over the dollars at stake, without pulling back and addressing root causes of HAIs in a systematic manner.

And what sort of campaign do we need in this circumstance?  A consciousness-raising campaign, so that (1) the empowered patient can insist on provider transparency, and create additional market forces pulling or pushing providers away from the marketplace that has allowed the preventable HAI count to swell, and (2) engaged providers can work to prevent the preventable HAIs and communicate the value and quality of care that they can deliver to patients and potential patients.

One possible meeting ground for like-minded patients and providers on this issue is the Society for Participatory Medicine (yes, another shameless plug for the Society and its journal, blog and listserv -- full disclosure: I am chair of its public policy committee).  Join us! 

Participatory Medicine is a movement in which networked patients shift from being mere passengers to responsible drivers of their health, and in which providers encourage and value them as full partners.

Again, the infographic may introduce the problem to folks who may not be aware of it, but the real work lies in solving the problem, not just realizing that there is one.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

David Harlow quoted in AMA American Medical News story on geolocation services

As health care providers continue to wonder whether and how they should add social media to their mix of communications tactics, new tools -- and new uses for those tools -- continue to sprout up. 

I'm quoted in the current edition of American Medical News in a story that looks at the question of whether and how health care providers should use geolocation services (e.g., Foursquare, Gowalla) as additional channels through which they may communicate with patients, colleagues and referral sources -- or through which they may encourage patients and others to communicate among themselves.

I've touched on this issue in recent presentations on health care social media, and have noted that even "checking in" on line at an STD clinic -- an activity discounted by Mark Scrimshire in the article -- is something that people will do for a badge -- check out this fall's MTV/Foursquare Get Yourself Tested campaign.  (Taking it to the next level, targeted sharing of STD test results is the idea behind start-up Qpid.me.)

Health care providers can leverage the general public's interest in using geolocation services in a variety of ways.  In the the article, Chris Boyer notes that his health system works to ensure that check-in data (addresses and phone numbers drawn from other online services) for each service location is accurate, but doesn't necessarily encourage check-ins.

There are no HIPAA issues raised by patients "checking in" on line, since it's a voluntary act by the patient, and doesn't really involve the provider.  Providers might decide to encourage check-ins (but not repeat visits -- we want to keep people healthy, right?) as a way to drive patients to links to targeted health information, or even, perhaps, coupons for coffee or something (as long as we don't bump up agianst limits on financial incentives ... though I think that would not be an issue under most circumstances.

Physicians and other providers could be encouraged to use geolocation services in ways that could promote crowing about adoption of best practices (hat tip to Nick Dawson) or achieving success in meeting targets for quality measures -- Be the first on your medical staff to become the mayor of the MRSA-free zone!  Get a badge for formulary compliance!

The possibilities are endless, and there are no deal-breaker regulatory restraints -- folks just need to be cognizant of the guardrails.

How would you like to see geolocation services used in health care? 

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

GE Healthcare IT's SVP and General Manager of eHealth Earl Jones speaks with David Harlow about the connected health care ecosystem

GE Healthcare IT has been working in the years leading up to the HITECH Act on a number of initiatives to enable meaningful use of health care IT -- or as Senior VP and General Manager of eHealth Earl Jones puts it, building the "connected health care ecosystem."

In what may be seen as either a pragmatic move or a revolutionary one, GE is developing tools that allow for communication across health care IT systems -- not just connecting one GE Centricity installation with another -- but acting as a technology-agnostic bridge for information across health care IT systems and across health systems.  While Jones notes that we're in the early stages of linking isolated lily pads across the surface of a pond, GE is developing tools that not only facilitate interoperability, but also facilitate the dissemination of medical knowledghe and the use of clinical decision rules developed locally or by pacesetting health systems (e.g., Mayo, Intermountain -- see the discussion of Qualibria below).

The audio file of my interview with Earl Jones (about 35 minutes long) is available for download/podcast.  A full transcript is at the end of this post (and in the linked Earl Jones, SVP and GM, eHealth, GE Healthcare IT, HealthBlawg interview transcript).

While he is necessarily politic about the role of regulators in the development of health care IT, Jones is clearly excited about the breadth and depth of GE Healthcare IT's reach, the way in which its priorities dovetail with change management initiatives in US government, and the ways in which it can enable clinical care and population health improvements.  Please join us for a wide-ranging discussion of these issues.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HealthBlawg :: David Harlow’s Health Care Law Blog

Interview of Earl Jones, SVP and GM, eHealth, GE Healthcare IT

April 1, 2010

David Harlow: This is David Harlow at Health Blawg and I have with me today Earl Jones, who is the Senior Vice President and General Manager for eHealth at GE Healthcare IT. Hello Earl, how are you today?

Earl Jones: I am doing just great, thank you.

David Harlow: Well thank you for being with us Earl. I have to ask you, first question as we start off today is - I’d like to ask you to define eHealth. That is the definition of your bailiwick.

Earl Jones: Sure. So eHealth speaks to this concept of the connected health care ecosystem. So I think all of us as professionals in the health care industry, but also as patients in the health care industry deal with really frustrating issues associated with moving clinical information from provider to provider. The classic use cases that we talk about are: mom goes to the hospital with her kids would really love to have medical information from their primary care physician. That information isn’t available to the hospitalist at the time of care treatment. Trying to get information from the hospital back to your primary care physician, those are challenging. That ability to move clinical information around the health care community is -- causes problems at that care level, also causes some, or it precludes us from getting at some real opportunities to improve the health care system like making cross-enterprise workflows faster, easier, cheaper; allowing us to do new care models like managing chronic diseases better, like bringing things like clinical decision support and population health to bear.

So eHealth speaks to this concept of the things that we can do in the connected health care ecosystem. We define eHealth more structurally as, at its core, health information exchange, the ability to take health information exchange and to do things with it. So collaborative workflows and then trying to bring performance application like quality reporting and clinical decision support and make those things available across the enterprise. So that’s what we think about when we think about eHealth.

David Harlow: Okay, great. This division or business unit within GE Healthcare has been formalized within the past 6 to 12 months I believe, maybe slightly more recently.

Earl Jones: Yeah.

David Harlow: Is that a structural change is that a new focus for GE Healthcare or is it a new name for what you’ve been doing previously?

Earl Jones: So I think it might be helpful to put GE Healthcare IT into context. So GE Healthcare as you know we are a big global health care technology provider. GE Healthcare is about an $18 billion business and it does three things primarily. GE Healthcare does diagnostic technology, MRI, CT, PET ultrasound, really focused on core health care technology. GE Healthcare does life sciences, so protein synthesis for example, bio-markers, the whole area of life sciences. And then the third part of GE Healthcare is GE Healthcare IT. And so we’re a multi-billion dollar global healthcare IT provider. And GE Healthcare IT has traditionally done three things; imaging systems, that’s radiological information systems, picture archiving; software for hospitals; and then software for physician practices. This concept of eHealth -- we started it as a new product line last year. But it was really born out of work that we started about 5 years ago, long before health information exchange or eHealth were topical issues like they are today.

We started this issue with a handful of our customers a few years ago who just had this problem of, wow, I wish we could share clinical information within our community and we started working with them around terminology, around hosting services, around translation, de-duplication services, really putting that core infrastructure in place that allows clinical information sharing. So it’s something we’ve been doing for several years. But last year we elected to break this out into its own business unit for a couple of reasons; one is certainly with the stimulus that’s happening here nationally and there is a lot of stimulus and attention on eHealth infrastructure globally. We thought it would be a little easier to talk about ourselves and what we are doing for our customers with our technology.

The second is, and I think it’s an important issue – it’s important to keep in mind, if you really want to enable cross-community clinical information sharing you have to be able to do it in a technology-agnostic way, this can’t be about sharing information amongst GE systems from hospitals to doctors office to specialty facility. It’s got to be able to share – we’ve got to be able to share clinical information in the environment that our customers live in and that environment is heterogeneous software applications, a disconnected variety of terminologies, the continuum along adoption of standards varies dramatically, I mean that’s the technical and systems complexity that our customers live in. And so it’s important for us to break this out into its own product line, really send the message that this isn’t about GE Centricity connectivity; it’s about enabling clinical information sharing in the environment that our customers live in without having to rip or replace any software.

David Harlow: Well that sort information sharing really sounds like the holy grail of Health IT and I am wondering how successful you’ve been or where you see yourself on the trajectory of really implementing that kind of connectivity?

Earl Jones: We feel like this has a transformative potential, this whole movement of connected care has a transformative potential in healthcare. Now let me characterize this by an example; I spent a lot of my early career in supply chain, and I was there when the factory couldn’t talk to the warehouse and you literally would have to write down material pulls on a piece of paper and send a runner off to get material. And in the span of a relatively short amount of time, 15 years, we went from that to a globally connected supply chain. And every metric that you can think of in supply chain got better, profitability, performance, service level, velocity. New business models were created; it was transformative when we connected trading partners in supply chain. And I think that kind of analogy, kind of parallel is exactly -- we’re on the precipice or the beginning phases of seeing that happened in healthcare. And we’ve been working with customers that are doing some very interesting things. One of our customers is The Boston Medical Center and The Boston Medical Center -- it’s an inner-city hospital here in Boston – it’s connected with 13 unaffiliated clinics. So clinics that have a different governance structure from Boston Medical Center.

And they came together and they said wouldn’t it be great if we could share clinical information in our community? And they did that using our health information exchange technology, and they’re doing some really fun things with it, right? They are able to do things like health emergency room doctors make better care decisions. So it’s tough being an ER doc. An ER doc gets the patient, may have no medical history of the patient and often times they are dealing with some pretty acute issues. Now at The Boston Medical Center if a patient comes in, if they are part of the community and belong to one of the community clinics, if there is no medical record at the ER at the Boston Medical Center for the patient, the ER doc can look into the local clinics and via the health information exchange and get information about the patient. And these can be life-saving kinds of information, thing like allergies, medications that the patients are on. Being able to get that kind of clinical information to an ER doc is important.

They are also using the health information exchange to enable a better way of doing referrals management which in healthcare is an awkward and expensive process that often ends with a lot of patient and doctor frustration because it’s not well managed from an information perspective. They are doing population health, right? They’re able to, now, because of sharing clinical information in their community, they’re able to understand the overall impact of some of their patient outreach programs because they can actually see it in the data whether they are making a difference. So, here we are in Boston, small hospital, a relatively small community, doing some really important things in their community because they’re able to share clinical information. That’s kind of exciting.

David Harlow: It is -- and I guess the next step is to see whether this can be bridged beyond a local system where it’s a dozen or so community health centers that are affiliated with Boston Medical Center and take that beyond. So someone who is away from home, out of town, goes into an emergency room can those records be pulled up remotely or is that something that you see us heading toward?

Earl Jones: I think we are squarely in the early adoption phase of this whole eHealth program. I mean we’re in the first steps of the first mile of a marathon. But looking at parallels in other industries, if we stay committed, if we continue to focus on value, in the span of what could also be a relatively short amount of time, it’s not inconceivable that we’ll have the way to share the information nationally for the betterment of care providers and patients. So we’re not there yet, I mean you can think of where we’re heading as lily pads on a pond that we’re going to see a lot of community health exchanges like Boston Medical Center pop up and start filling the pond and the good news is that organizations like IHE have been thinking about how do we make these lily pads, how do we make these community health information exchanges, work together and so there are good protocols and methodologies for cross-community access of information that over time we’ll see get built out.

David Harlow: Are you optimistic about some of the Federal initiatives building on the ARRA and HITECH Act initiatives on local medical records systems, to build out the NHIN Connector or other sorts of interchange infrastructures, through Beacon Communities or other programs?

Earl Jones: I give ONC a lot of credit. This is a thorny problem, a lot of stakeholders, a lot of different ways to come at this, and what they have done is they said look here are some functional requirement of things that we want to try to get accomplished because they are going to make the health care system better. Here’s $42 billion to help get you going, and if you aren’t adopting the technology for the betterment of our national health care system, in a handful of years we’re are going to move from carrot to stick, it’s just conceptually, what they are trying to do from an overall change management perspective makes a ton of sense and it really by any measure what the ONC has done has really crystallized this concept of connected care in our industry.

NHIN is interesting, I think NHIN is evolving; I am not sure what NHIN will look like whether it will be servers moving data or it will be just a concept that we are building toward. I don’t know what it is going to look like in future I am not sure ONC does I think that’s something that’s evolving and I think that’s okay. This concept of Beacon Communities which you brought up I think is brilliant. You know in any large organization change management -- and by any definition trying to change US health care system is a large organization change management problem -- one of the best ways to drive momentum behind the change program is to create showcases. You know, let’s go create some examples of where people are out ahead of the curve in technology options, out ahead of the curve in thinking through new process and ways of using data and bringing communities together. In using those showcases sort of as beacons to bring the rest of the organization along and in context, I thought the Beacon Communities program is brilliant and you know let’s hope that monies that gets flown down to Beacon Communities when the final grants are announced, let’s hope that folks put that money to good use and really create some spectacular showcases that prove the case for why connected health care is so important.

David Harlow: Now we might say that the government gives with one hand and maybe takes away with the other. In concert with the grantmaking and incentive producing rules and regulations that have been coming out, there is also now a discussion about regulation of health care IT as a device by authority of the Food and Drug Administration. I guess some would say that you can’t really serve two masters, and that the Federal government should come up with some sort of integrated approach on eHealth and EHRs and other related systems and programs. The FDA is working with ONC on trying to develop a way to work together, I suppose. I am wondering if you could speak to through your experience with these organizations, these agencies, and where do you see this heading? Where would you expect this to end up? Or where would you like this to end up?

Earl Jones: The FDA often gets tough rap because their job is tough one. They really perform an important public service which is ensuring that things like health care are out there for the betterment of the citizens of the nation and aren’t doing negative things around helping improve people’s health and welfare, so you know they have a tough job, I have tremendous respect for professionals that work in FDA and you know I think they wake up every day really thinking about how they do their job as best as they can do it to protect the citizens in the US. As far as my experience has been they have been very, very reasonable in their approaches. I think they could take some very draconian regulatory positions if all they want to do is think about their job only as regulator. But I have always found them to be very open in thinking about how to work through a problem in a balanced way and as far as I can tell when it comes to health records they are doing that very thing. They haven’t just launched in, saying look, we’re going to go regulate it, they haven’t said that this is off the table either, because they recognize the importance of IT in the overall health care continuum.

So, from my observation is they are taking a very measured approach. All I can say however it comes out you know GE is no stranger to regulated environments we are ready for it; if it doesn’t get regulated, that’s fine to. The only thing that I think we would encourage is -- let’s not slow the progress down that ONC is driving; I think we really do have some great momentum, if it ends up regulated let’s come at it in a way that doesn’t slow the market down. I think that calls for good balance, good collaboration and my sense is that FDA has got that top of mind.

David Harlow: So I think that the FDA may be working together with ONC so that some of these regulations may end up folded into the meaningful use certification process. So to the extent that all can be harmonized, it’ll certainly be better than having to deal with two separate organizations.

You spoke earlier about respecting the patient-centered aspect of health care IT and I am wondering whether you see this sort of regulation as a challenge to that? And also whether -- how you would characterize some of the work that your organization has being doing, in meeting the needs of patients in a patient-centered sort of way.

Earl Jones: Yeah. It’s a great question. I think there is a lot of discussion around moving from a payor/provider-centric to let’s go put the patients in the middle because that’s really at the end of the day what’s this is all about – care, treatment, for the patient. And I think it’s a very healthy dialog. The whole concept of electronic health records, and again let me just be clear electronic medical record -- think of it as sitting on a computer in a doctor’s office, literally or virtually. Electronic health record is a sum aggregation of the health information of the patient that lives within a healthcare community. And this concept of electronic health record, one patient, one record available to the primary and specialty care providers that are treating a patient, that’s a very patient-centric concept which is absolutely what we’re trying to enable with eHealth. Things like privacy and security -- those things we take very seriously and are very integral parts of our health information exchange infrastructure. And -- so I think this whole focus of how do we empower patients more, with better information, better tools and do it in a safe, secure private way is exactly what we are trying to do with our solutions.

David Harlow: Great. Now one of the solutions or products that you’re rolling out is Qualibria, which was previewed or announced at the HIMSS conference a month or so ago. I am wondering if you could explain a little bit what that system is, what it’s built on, and how you see it rolling out?

Earl Jones: Sure. We are exceptionally excited about Qualibria. Qualibria is a clinical knowledge platform. So what does that mean? Let me characterize this by the problem that we were trying to solve with this technology. Dartmouth did a study and said if everybody in the nation was as good at care treatment as the Mayo clinic, they said $40 billion would have come off that number [cost of care] and if everybody was as good as Intermountain something like $119 billion would come off the number. I am probably misquoting the numbers. But the concept is it turns out Mayo and Intermountain are really good at what they do and if we could just harmonize and reduce the variation in care treatment across the country, we could take a substantial chunk of the cost out of the system by just providing better care.  There are couple of other alarming stats that go along with this; one is that the medical body of knowledge is doubling every 8 years, or more quickly. And I think we can go: Wow, when all this genomic stuff starts hitting, we start getting really targeted around that kind of care treatment based on genomic data you can see the medical body of knowledge exploding even at a more accelerated rate. Tie that in with the fact that it may take as much as 17 years for a best practice to propagate out throughout the medical community, you quickly get this vision of, wow, there’s a lot of variation in the quality of care delivered and as it turns out, we patients only get the best practice treatment -- for whatever the disease state or illness or injury that we’re dealing with -- we only get the best practice care treatment a little over half the time, like 55% of the time.

So the problem Qualibria was trying to solve was, wow, can IT do something to make that better? And it turns out it’s really hard. The things that Mayo and Intermountain are doing – they’re instantiated their own systems but they are pretty complicated sort of flow chart processes for treating something like acute respiratory disorder. I mean it can be as detailed as: at this time turn the respirator to this value, give the medication certain minutes after this care treatment.

Trying to take that and do it in a system like Intermountain’s hard. Trying to translate that across systems, turns out you had to rethink the architecture. And that’s what we did with Qualibria. So with this partnership with Intermountain and Mayo we launched into a total rethink of a technology architecture which includes a pretty advanced clinical element model and something like several tens of thousands of rules that are then built on top of the clinical element model that allow you to take complex terminologies, draw insights and attributes from that and use that clinical element model to create decision support tools. And Qualibria is our first product that’s going to roll out from the partnership with Intermountain and it’s designed to do that very thing, which is take disparate information, aggregate it, be able to put single patient, multi-patient views with clear alerts and processes and tracking that can immediately become useful -- I don’t have to rip anything and replace it -- drop it in and immediately become useful in a hospital clinical setting in driving better coordinated care. So it’s very exciting.

David Harlow: You sound excited; sounds like a very exciting project and product. So do you see this rolling out beyond Intermountain and Mayo in the near future?

Earl Jones: Yeah absolutely. I think our product plan is to – so it’s up and running now -- and to roll it out to a couple more controlled sites the balance of this year, before a more broad national rollout in 2011 and will quickly be followed by international rollouts as well. So it’s something that we put a lot of research and development money into, we’ve got great partners that are helping us and I think it’s important to point out that we love Mayo, we love Intermountain -- I mean their bona fides are tremendous. But there are a number of healthcare institutions that are doing some really wonderful things in advancing the medical body of knowledge on specific care protocol treatments. And this technology can allow them to better and more quickly roll out the things that they learn as well. You can build your rules right into the tool. So we’ll have care bundles that are mapped after what Intermountain and Mayo do; it’s also going to be a wonderful environment to quickly take things that hospital systems are doing in an excellent fashion themselves and instantiating that in a tool that can be rolled out across their enterprise.

David Harlow: Now with this new kind of tool, do you have a concern about new kinds of liabilities, legal liabilities, as you are essentially rolling out as you said bundles of decisions support rules -- does that not come along with additional liabilities, whether it’s the content or the application of the rules or even perhaps a different kind of liability interms of encountering corrupted data or other sorts of problems rather than the decisionsupport rules themselves.

Earl Jones: Well I am not the best person to answer that question. Certainly we take all these things tremendously seriously and it’s been very well thought through. None of this replaces the need to have experienced care professionals orchestrating the care delivery, right? This isn’t -- lets get rid of docs and nurses. This is about how do we help docs and nurses deal with the tremendous complexity and a tremendous body of knowledge and time variant change of body of knowledge. It’s about giving them some tools that can help them do their jobs better. So I think that’s a very important distinction that -- I think there is a statement that says something to the effect that the complexity of modern health care surpasses the human mind sort of gets your mind around it. It’s too big for anybody so we think that what we are trying to do is not replace docs and nurses -- quite the opposite – it’s to give them some important tools to help them do their jobs better.

David Harlow: So are these tools part of what the company has been referring to as healthymagination and a large investment and innovation and health care?

Earl Jones: That’s certainly part of healthymagination so let’s talk about healthy. And first I’m going to talk about something different -- I am going to talk about ecomagination. So we launched this program about five years ago called ecomagination and at the time one of the real pressing global issues is the environment; it still is. It’s a huge, huge problem, and Jeff Immelt, to his great credit, stood back and said, you know, as the General Electric Company we can be doing more to help this important issue of environmental sustainability. He said let’s do it like an operating company, like GE ought to do it, which is let’s set ourselves some clear goals, clear metrics and really rally behind it not just as a fad initiative but as something that becomes part of our culture and DNA and we called it ecomagination. We said that we are going to invest more in environmentally-friendly technologies, we are going to do our job to try to inform the public on issues related to the environment, and then we are going to try to walk the talk and reduce our own greenhouse gas emissions as an enterprise and that was launched a handful of years ago and it was just a smashing success -- great for our employees, great for our customers, and really it was a revitalization of our culture around environmental sustainability.

A couple of years ago Jeff sort of took a step back and said health care is going to be -- it is, and will continue to be -- a pressing global problem of tremendous importance and magnitude and not only are we a big health care technology company but GE pays a tremendous amount of money, several billions of dollars in health care costs each year. He said we can be doing more as the General Electric Company to lead in the evolution of health care. So in a parallel construct we launched this initiative called healthymagination. Yet again, as a good operating company, what are we trying to do? It’s really focused around bringing innovative technologies -- this doesn’t mean high technologies it means innovative technologies. Some may be high technology some may be low technology but innovative technologies to help improve quality of care delivered, reduce the cost of care delivered and improve access, and we are going to put about six billion dollars of investment into technologies globally aimed at these three metrics. We’re doing our job to inform the public about issues related to health care. We launched the largest advertising campaign in the General Electric Company’s history, I believe, earlier in the year concurrent with the Olympics with some really lovely -- some times funny, sometimes poignant -- commercials around health care, I think they were very well received. And so healthymagination is more than an initiative -- it’s a major focus for the company, again trying to get at culture, DNA, around thinking about health care differently and making sure that we as the General Electric Company are doing our part trying to help the world improve on cost, quality, and access to health care.

David Harlow: OK, well thank you. So any last words on what you are doing now and how you see your division moving forward under the HITECH Act and now under the new health reform law?

Earl Jones: Well certainly we’re very happy about the HITECH Act -- that’s been great for the industry. I don’t know there is a whole lot of – well, some money has been flowing down, so it’s been great, but more than anything else it really has gotten people galvanized and motivated and gained some momentum around changing the landscape of health care IT, which is great. But, by the way, this is happening on a global basis, so sometimes we like to think about the world as being the 50 states here, but there are some folks in China, in Singapore, in India, in the Middle East, in Saudi Arabia, in Europe, in Brazil, I mean folks are really doing some innovative things with health care IT globally and so eHealth is absolutely playing in that arena. We are very focused on delivering value for our customers here domestically, but frankly just very focused and very passionate about the opportunities to help health systems and countries on a global basis as well. With reform, with health care, HITECH Act, with all that, the challenge that we have, and I think other people may have it as well, is not to get carried away – we’ve got to stay good at what we do, which is sort of sticking to our knitting, if you will, which is working with hospitals, working with IDNs, working with health information organizations, but working with folks around delivering real, concrete, measurable value. And I think as long as we do that and stay focused on solving the problems and pain and enabling new care delivery models, enabling new transparency and performance reporting -- as long as we stay focused on what we do well, I think we feel very good about the future. We love all the reform, we love the HITECH Act, but I don’t want to get carried away and focus on chasing that money. I think we’re just going to stay focused on trying to solve hard problems for our customers.

David Harlow: Sounds like a plan. Thank you very much. I have been speaking to Earl Jones Senior Vice president and General Manager for eHealth at GE Healthcare IT and this again is David Harlow on HealthBlawg, thank you once more.

John Glaser, CIO of Partners Health Care, speaks with David Harlow about health IT and meaningful use in a $7.9 billion health system

What does a large health system CIO worry about if his system is already fully up to speed in the day-to-day use of EHRs?  Using them in ways that improve communication of information across a diverse group of clinicians, and that enable the integration of additional interesting and useful data as time goes on -- such as the integration of genetic testing data into the diagnostic and treatment logic built into the EHR.

John Glaser explains how Partners uses its EHR system to leverage knowledge for the benefit of patients, and describes some of the ways in which decision support systems are being used today and may be used in the future.  

Tools in place at Partners now:

[T]here is for example a monthly report put out on dozens and dozens of quality measures and they are coded red, yellow, green depending where we are relative to the national benchmarks and that . . . allows us to focus on areas that do need some attention.  In addition to that you can use the systems like CPOE or the EHR to introduce logic at the time of care, so to make sure that an order is a safe order or that an overdue health maintenance activity has been noted and followup is occurring.

...

[L]argely at this point focused on cancer . . . we do have decision support that says before you order this chemotherapeutic agent you should run this genetic test because that will tell you whether the agent will or will not be successful.  We do have a piece of software called the patient genome explorer which sits right beside the results viewer for chemistry results, and this allows you to look up genetic test results and understand the ramifications for the patient you are treating.

Glaser acknowledges the difficulties that may be faced by smaller provider organizations in gearing up to meet the meaningful use criteria related to EHR implementation, but notes that for him, there is no separate ROI calculation for implementation of these tools, saying

I mean, what’s the ROI of email? Beats me but, nonetheless, few of us could get through a day without it.  At other times the ROI is quite tangible because you could say golly, we are cutting real costs here or making real revenue.  At times the outcome is tangible - it may not always be expressible in terms of dollars.  You can, but that’s not the point. . . .  So I think we will see a return broadly speaking . . . .  I think at the end of the day it is one of those things which you say listen, this is a given.  It is hard to imagine that we would sit here today and say if ten years from now we ran our health care system on paper that would be okay or a good thing.

The Partners team has the luxury of being able to spend significant time on R&D, and Glaser says that

we do have some people who are looking at different techniques to be applied to putting a layer of logic on top of complex and idiosyncratic data coming in, and teasing out that sort of data. So, for example, if you know that there are, let’s say, 200 notes [in a patient's EHR, entered by a variety of clinicians] and that the patient is being seen by a cardiologist, you just have the system be able to identify that subset of notes that appear to have a bearing on the consultation in question and being able to categorize those notes for the doctor, so that he or she can say jeez, of the 200, there are five that are related to prior cardiac events, there are four that are related to what appear to be cardiac procedures . . . to help to filter through and surface that subset of note, or other data, which appears to be the most salient.  So we are learning.  We are trying a bunch of different techniques to figure out how to do that.

And a final note on meaningful use: The transcription service I use (which is based in India) rendered "interoperability" as "entrapped ability" in the first draft of the transcript -- an unwitting bit of wry commentary on the need to unlock the potential of EHRs through the kind of broader thinking shared in today's interview.  I think you'll find it to be an interesting read or listen. 

The audio file of my interview with John Glaser (about 25 minutes long) is available for download/podcast.  A full transcript is at the end of this post (and in the linked John Glaser, CIO, Partners Health Care, HealthBlawg interview transcript).

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HealthBlawg :: David Harlow’s Health Care Law Blog
Interview of John Glaser, CIO of Partners Health Care

March 3, 2010

David Harlow:  This is David Harlow at HealthBlawg, and I have with me today John Glaser, the CIO at Partners Health Care in Boston.  Hello John, thank you for joining us.

John Glaser:  It’s a pleasure, David.

David Harlow:  So Partners Health Care - for those of you who are not familiar with it - is an organization that includes ten hospitals, 7000 physicians, 45000 employees.  Have I got that right, John, more or less?

John Glaser:  Yes, you do.

David Harlow:  And John has been the CIO at Partners for quite some time.  He’s also been acting as an advisor to the ONC on implementation of the HITECH Act since last spring.  We’ll try to steer clear of government-related issues today and focus on issues at Partners.  So John, moving beyond the numbers, how would you describe Partners Health Care and what it means to be CIO of Partners?

John Glaser:  Well, Partners Health Care has got a couple of attributes.  One is it’s large, so we’ve got another number to put in there, it’s about 7.9 billion in revenue and in addition to its hospitals and extensive array of outpatient clinics, physician practices and 90 key facilities, it’s a very large, very complex organization.  It’s also quite academic given its two founders [Massachusetts General Hospital and Brigham and Women’s Hospital, both of which are major teaching affiliates of Harvard Medical School].  So it has tremendous resources, tremendous talent, some world class organizations, and using those assets it can be a challenge at times to line everybody up and have the organization move in a concerted direction. I guess that’s true of all large organizations, although we certainly feel that at Partners. And while that can be difficult at times, the fact that there is such talent, and there is such a commitment to the mission of care, research and education makes it worthwhile and enables us to accomplish - from time to time - some very remarkable things.

David Harlow:  Would you say that things have gotten easier as the association has lasted longer, or more complex as it’s grown larger? You’ve been with the organization quite some time now and I was wondering how things have changed over the years.

John Glaser:  Well I have been for quite some time. I’ve been the CIO since 1995 and so that’s a little over 15 years.  And prior to that, CIO at the Brigham for another seven years, so 22 plus years in the family as a whole.

So I think it’s very clear that as the organization has matured and has begun to understand how to work together, that it is more effective at working together, bringing together very disparate organizations, large AMC’s, small community hospitals, for example, bringing together people who may or may not have a track record of working together.  So it is better at moving as an integrated system than it has been in years past.

On the other hand, the challenges it has to address have become more significant so there are greater cost pressures today than there were ten years ago and there are greater quality pressures than there were ten years ago.

The pace of medical innovation and events are more significant. As our community of clinicians and others have become more experienced with the technology, they also become more demanding and more sophisticated.  So the demands and the expectations are higher and have been paralleled by a growing ability to work together as a collective.

David Harlow:  So going back to a couple of things that you said specifically, I’m wondering if you could tell us, how does the health information technology function within Partners help to enable the organization to deal with some of these issues - whether it’s adherence to quality measures; whether it’s dealing with payment issues - and, how does your function, your part of the organization’s function integrate with the clinical function?

John Glaser:  Well, there are a number of ways in which we try – and, at times, succeed - in helping Partners address these challenges.  At times we take processes and make them more efficient and save money in addition to having those processes work faster, be less error-prone, etc.

By providing data that comes out of the EHR, the organization’s in a much better position to look at variations in care practices and identify those practices that are more efficient than others, that are of better quality than others.  I actually have the data to assess quality and to then deal with that variation in whatever manner it chooses to do so.  So the fact that you have clinical data, and data that also brings along the cost component of that clinical data, allows us to look at where we need to do some work, where we don’t.

So there is for example a monthly report put out on dozens and dozens of quality measures and they are coded red, yellow, green depending where we are relative to the national benchmarks and that again allows us to focus on areas that do need some attention.  In addition to that you can use the systems like CPOE or the EHR to introduce logic at the time of care, so to make sure that an order is a safe order or that an overdue health maintenance activity has been noted and followup is occurring.

So through the transactions systems one has the ability to carry out a lot of the guidance and recommended care that comes out of the data activities.  So there is a series of analysis capabilities and transaction capabilities that help address this complicated mixture of cost, quality and safety.  But also in addition to that is the ability to adapt.  So for example it’s fairly clear in the next several years - 3 to 5 for example - genetic testing will be increasingly a lager component of health care because of our greater understanding of your genetic makeup and how it guides treatment decisions, or what disease you really have.

And so the ability of systems to adapt and to capitalize on advances in medical care, to capitalize on advances in care models such as the medical home or accountable care organizations, and also capitalize on the gains that new technology can bring - that we are trying to make sure that our infrastructure and applications are able to move as the collective environment moves.

David Harlow:  Now I understand a few years back you established together, Partners established together with Harvard Medical School a center for genetics and genomics and is this what you are talking about, is this informing some of the care management, is there genetic testing data that’s included in patient profiles that can be used to guide clinical services?

John Glaser:  Yeah, we formed several years ago what is now called the Partners Center for Personalized Genetic Medicine, and it has two major roles.  One is to facilitate research into the genomic basis of disease or treatment variability.  So for example if you are clinically depressed and given an SSRI, it works well a third of the time, medium well a third of the time and not at all a third of the time, and so helping investigators determine whether there’s a genetic underpinning to that.

So we’ve learned a lot and this will help accelerate research into how genes contribute to our disease and our treatment success for example.  In addition to that, that is also not only because of the advances themselves but the knowledge of how do you store genetic test results and what does genetic decision support look like, how do you present genetic test results to the clinician.  It’s begun to make its way into the clinical systems, largely at this point focused on cancer, but we do have decision support that says before you order this chemotherapeutic agent you should run this genetic test because that will tell you whether the agent will or will not be successful.  We do have a piece of software called the patient genome explorer which sits right beside the results viewer for chemistry results, and this allows you to look up genetic test results and understand the ramifications for the patient you are treating.

David Harlow: Is there an overlay now with the GINA legislation on top of HIPAA in terms of privacy requirements and protection requirements, encryption, others, relating to genetic information that’s on the system or does HIPAA deal with that sufficiently?

John Glaser:  Well, there are clear genetic privacy ramifications for all of this and it gets complicated.  I will give you two examples.  If a genetic test were to say that you or I were at great risk of a debilitating form of dementia, one would say, well, I ought to keep that private, because of – for lots of different reasons.

On the other hand, a genetic test result that says you will be a slow metabolizer of sulfa drugs, you might say -- jeez, I’m less worried about loss of job or loss of insurance based on that. But I do want my doctor to know because I do want to make sure they don’t inadvertently overdose me on a particular drug.  So genetic test results actually span the gamut of those which are highly sensitive to those which I think most people regard as no more sensitive than a blood potassium reading.

And given that, nonetheless, what we have decided to do is to treat any genetic test result as being in the same category as the most sensitive data and so this is HIV data, this is mental health data - we treat that and provide both the policy procedure the consenting processes for example but also the IT controls over that type of data that we would - I think perhaps society may evolve to the point where it categorizes genetic data into different forms or buckets of sensitivity.  But until that’s the case, we will treat it as the most sensitive.

David Harlow:  So you’re not looking to get patient consent to disclose certain types of genetic information like for example the way you would…

John Glaser:  Yeah just as you would on any sort of highly sensitive set of data.

David Harlow:  Okay.  One area of interest at Partners is the electronic health record and the use of electronic health records over time, which, I understand, is a home grown system.  Is that right?

John Glaser:  Yes -  the bulk of our, we have approximately 4200 physician users of our outpatient EHR, 85% use the homegrown version and 15% use a mix of GE and a couple of other systems that have been in place for quite a while.

David Harlow:  And what would you recommend, having had the experience with both?  What words of wisdom would you have for other providers who are looking at implementing EHR systems in this era of HITECH incentives?

John Glaser:  Well I think these systems, whether you build them yourself or you buy them from the market - and most people buy them from the market, and most people should buy them from the market - these are a challenge to get in place.  They are very invasive to the workflow and so a physician, or a nurse practitioner or any other health care professional who now is documenting on them, writing orders on them, reviewing results, - it’s very invasive.  It’s not something that is kind of off to the side.

And as a result there is a great deal of demand for systems that have a lot of strong features, functions, but also are very usable and quick.  It requires that workflow be understood, changed if necessary and that includes where do you place printers and things like that. It requires a good deal of training and some strong support, and I think practices who undergo this should be prepared for several months - and it seems to vary at least in our practices, sometimes it’s as long as six months, sometimes it’s short as two months - where there is a form of disruption and people just getting their feet wet and getting oriented to this.  So there are a lot of demands on the systems, there are a lot of demands on the implementation process and the workflow change process and there are a lot of demands on support, and obviously there are a lot of demands on the practice who goes through this.  Nonetheless once you get through that we have never had any clinician of any form say I wish I could go back to paper.

They clearly see that the care is better, that there have been some efficiencies gained, there’s been some challenges.  Sometimes it takes longer to do certain tasks.  But nonetheless it is a journey that is - both from the care perspective and the cost of care overall but also the ability of the providers to say I’m practicing good medicine, must be able to say that.  So I think it is a hard journey but it is a worthwhile journey that the federal government incentives recognize the importance of us collectively moving in that direction.

David Harlow:  Part of the issue is the interoperability, the opportunity for free exhange of data from one provider’s electronic health record to another, to be able to follow a patient across care settings.  Given the size and the scope of the Partners network, I’m wondering how important the development of RHIOs and health information exchanges are to Partners? Are patients who are seen within the Partners’ network receiving all of their care within the network?

John Glaser:  No and I think that some networks are more closed than others; the VA, Kaiser, are more closed than others. For example, almost 50% of our referrals – remembering we’re academic at our core - come from physicians outside of Partners. So we have extensive movement of people in and out of Partners, some stay within the Partners community but a lot don’t.

So I think this notion of exchanging data is critical, and it runs a sort of a gamut, it runs a gamut of giving the referring physician access to the core institutional systems, to the gamut of the movement of a structured transaction - maybe it’s an operative note, maybe it’s a set of chemistry results - from one system to the other.  At times we have clinical affiliations which are very strong and we wind up with shared scheduling systems, shared email systems and much more extensive integration and interoperability.

So I think the basic rubric of putting out standards and encouraging the exchange is a very important set of activities.  It creates parallel issues, it creates issues of making sure that the privacy and the security steps necessary are put in place, because we now have different privacy and security challenges when this occurs.  It also places a challenge on the providers who now may be going into their EHR and seeing lots and lots of data from lots and lots of other providers and saying holy smokes, I have a brief period of time with this patient, but I have 200 notes and 180 of them are not mine.  How do I wade through these and determine which ones are the most important? So a knowledge management function, and a decision support function, and a set of guidance using all of the above, might help the physician zero in on the most clinically relevant - becomes a challenge.  So there is, there is great gain to be had. It does bring some parallel challenges that we still need to address.

David Harlow:  Have you seen some movement in the direction of being able to wade through those kinds of notes, the kind of volume of notes there might be from outside providers, any sort of knowledge management systems that you are using or that is on the market today?

John Glaser:  Well, I don’t know about on the market.  We are, as an IS group, unusually academic in our approach - about 15% of our staff are funded by federal grants or through industry partnerships to explore leading-edge topics in healthcare IT and they run the gamut from what is known as telemedicine, to genetic medicine, to knowledge management – things like that.

But we do have some people who are looking at different techniques to be applied to putting a layer of logic on top of complex and idiosyncratic data coming in, and teasing out that sort of data. So, for example, if you know that there are, let’s say, 200 notes and that the patient is being seen by a cardiologist, you just have the system be able to identify that subset of notes that appear to have a bearing on the consultation in question and being able to categorize those notes for the doctor, so that he or she can say jeez, of the 200, there are five that are related to prior cardiac events, there are four that are related to what appear to be cardiac procedures.  So anyway to help to filter through and surface that subset of note, or other data, which appears to be the most salient.  So we are learning.  We are trying a bunch of different techniques to figure out how to do that.

David Harlow:  On a related note, some of the tools and products that have been on display at HIMMS this week or announced at HIMMS this week down in Atlanta – I’m wondering whether there are categories or particular types of tools coming out of that conference and from the exhibitors there that are of particular interest to you, something that catches your interest?

John Glaser:  Well, I was at HIMSS for only a day and I was only briefly on the exhibit floor so I didn’t get a chance to see what was going on.  I think in general obviously the major topic is the federal stimulus funds and how to address those.  So I think tools that invariably help providers to meet those meaningful use requirements or the standards and particularly help the smaller physician practice, the smaller hospital, which have very low adoption rates and have in general, not entirely but in general, not been as well served by the market as the larger organizations as technologies that are directed there are of great interest.  Anyway I didn’t have a chance to personally see a whole lot of the exhibit floor.

David Harlow:  Fair enough. What would you identify now as areas of opportunities as well as areas of challenge in adopting not only EHRs but also other health information technology tools across the health care spectrum?  Maybe speaking from your experience within Partners but also as you mentioned looking at some of the smaller providers which is where I think collectively we’re hoping there will be greater adoption.

John Glaser:  Well I think broadly, and across the country, we still have the challenge of getting higher adoption rates and now meaningful use of those technologies so those of you folks listening to this know the rates as well as I – but they’re low.  So that challenge which has been with us for a while, it’s still with us, and perhaps we’ll have a series of factors that will cause us to pursue it more aggressively and I think in particular, as has been mentioned before, it’s the smaller provider organizations which need the most innovative approaches to the delivery of these systems in helping those patients, and remembering that two-thirds of all of outpatient visits occur in physician practices of three or fewer docs. That’s where the bulk of care occurs in the US. So there is - that challenge is going to be with us for quite some time - several years.  And all that implies - the difficult work of implementation and some of the comments mentioned earlier.  In addition to that it is also clear that there are some opportunities emerging or at least will be different as result of broad adoption of interoperable electronic health records. One is itself the management of interoperability at scale, protection of privacy, the assurance of standards, helping docs deal with large volumes of information. And so there will be a series of things we’ll have to do and understand this is when you have interoperability at scale, what gain really occurs but also what challenges are present or revealed that we still need to develop tactics and tools to deal with.

The other is that there is a clearly going to happen or beginning to happen now, large accumulations of data about patients which can be used for comparative effectiveness research, clinical research, post-market surveillance of medications and devices, public health surveillance, etc.  And I think we have a lot to learn about how to manage that data, not only the protection of privacy but also how to distill patterns out of data which is often conflicting, noisy or incomplete.

The third area - we still have a lot of ground to cover - is how best to engage patients; we use the technology to engage patients - personal health records, personally-controlled health records, a lot of targeted applications where you can measure your blood sugar or your blood oxygen saturation, or whatever it might happen to be - people with chronic disease; we have a lot to learn there.

So lots of promise there but still relatively small levels of adoption and very limited understanding of how much of a contribution this will make to the management, let’s say, of a chronic disease, or the gradual improvement of health.  So there are a couple of big areas.

I guess one other big area is - if we have large bases of knowledge or decision support across wide ranges of systems - is managing this knowledge base.  A knowledge base of rules or order sets or templates, it is now quite sizable, which changes from time to time.  And I think one of the factors of our growing knowledge of the relationship between the genome and our health is whatever volume of decision support rules you think there are now – it’s going to go off the charts as that becomes increasingly incorporated into medical practice, so how best to manage that knowledge base and to ensure that it’s effective remains a daunting challenge.

So, as we address the core one, getting these systems in place and used well, and broadly looking at a series of challenges coming up that will result from the broad use of interoperable electronic health records.

David Harlow:  Do you see a direct correlation between the advances in the systems and the return on investment, if you will, or is this just part of the infrastructure that has to be in place in the future? Is this just like you need to have a telephone, you need to have this…

John Glaser:  Well I think it’s a combination of things. One is technology at the end of the day is a tool and, per se, guarantees no ROI and you see that in some of the studies they’ve done or sometimes great gains in patient safety have occurred, sometimes they haven’t, and sometimes the organization runs more efficiently and sometimes it doesn’t.

So we have very variable outcomes and partly because it’s not the tool that delivers the outcome, it’s the way that it is implemented and how effective it is.  So we will continue to see that because again it is at the mercy of the skill of change management and leadership and a wide variety of other things so, given that, we also recognize that that the nature of the return is really diverse, at times it is very intangible - I mean, what’s the ROI of email? Beats me but, nonetheless, few of us could get through a day without it.  At other times the ROI is quite tangible because you could say golly, we are cutting real costs here or making real revenue.  At times the outcome is tangible - it may not always be expressible in terms of dollars.  You can, but that’s not the point.  So if you are, if you deliver safer care, you can certainly measure the dollars there but those aren’t really the measures that people are focused on - or improved service.

So I think we will see a return broadly speaking - realizing how tangible or intangible, how dollarizable or not dollarizable it is, to the sort of settings in which it’s delivered.  I think at the end of the day it is one of those things which you say listen, this is a given.  It is hard to imagine that we would sit here today and say if ten years from now we ran our health care system on paper that would be okay or a good thing.

I think there are very few people who would stand up and try to carry that argument forward - at a face validity level, and at an empirical level, it just doesn’t make sense.  So I think the basic idea that if we really want to make extraordinary gains in the care in this country you have to have this foundation in place.  The foundation doesn’t guarantee it but it’s hard to imagine that you would accomplish it without it.

David Harlow:  Well, thank you very much.

John Glaser:  My pleasure.  I hope this is interesting and informative, and I appreciate the time.

David Harlow:  It certainly is.  I’ve been speaking with John Glaser, Chief Information Officer at Partners Health Care in Boston on implementation of health information technology and the improvement of health care. Thanks again, John.

John Glaser:  All right. Thank you, David.

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• Being John Glaser 11/10/09 (histalk2.com)

An ounce of prevention

Today's Boston Globe reports on a feature of the Massachusetts universal health care law that may be replicated at the national level: MassHealth -- the Massachusetts Medicaid program -- has been covering the costs for smoking cessation counseling and medications for eligible enrollees.

Using the data available, researchers were able to associate the roll-out of these services with a significant drop in smoking rates -- a drop not seen among the small percentage of Bay Staters who remain uninsured.

Not only that, but there are cost savings involved.  Fewer health care services are required by nonsmokers -- notably, less asthma and heart attack related services.

Thanks to aggressive promotion of the services through a variety of channels, 40% of eligible smokers enrolled, as opposed to the 5-10% that the program anticipated.

The success of this program had previously been announced by the Commonwealth in June.

Bottom line from the Globe:

Although the study being released today does not assess whether the stop-smoking campaign reduced health care costs overall, the findings led some advocates to call on the state to make all health plans - public and private - provide cessation programs with low co-pays and deductibles.

As health reform is further debated at the national level, we need to focus on the investments that may be made in the nation's health that will yield monetary as well as quality returns, and this initiative is certainly one that is worthy of closer examination.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

H1N1 Response Center - Microsoft launches interactive tool

Microsoft has just launched its H1N1 Response Center online, and I had the chance to speak this morning with David Cerino, General Manager of Microsoft Health Solutions Group (the man from HealthVault) and Arthur Kellermann, MD, Professor of Emergency Medicine and Associate Dean at Emory School of Medicine, about this new creation.

On the surface, it's a very simple H1N1 Q&A to take if you think you might have the flu.  It leads you through some questions and within a few screens tells you to go see your doctor or reassures you and suggests that you rest, push fluids, etc.  Since estimates of likely H1N1 infections in the US this season range from 20% to 40% of the population (i.e., 60-120 million people) any triage tool like this should be welcomed by health care providers and public health officials around the country.  In fact, they were involved in putting it together as a result of brainstorming sessions at a conference hosted by the Institute of Medicine on influenza-like illness in early September. 

Working with Microsoft, this tool was put together in about a month, and the algorithm can be tweaked easily over time as new information about the disease and the pandemic come to light.  (The current algorithm is adult-only.  The under-12 set will be picked up within a couple weeks; the American Academy of Pediatrics is working on it.) 

So far, so good: a questionnaire that you can review at home (i.e., without overwhelming waiting rooms and exposing yourself to sick people if you don't really need to see a medical professional) that gives you recommendations, links to resources, etc., related to your individual responses.

The next step: when you're done, the system prompts you to save your responses in your Health Vault PHR, or to set one up first if you don't have one yet.  You can then authorize your doc -- if he or she is on Health Vault -- to see your responses.  Sick people should get medical attention; the "worried well" should stay out of the way.

Coming soon: at the end of the questionnaire, you can have the option to upload data and consult with a doc via TelaDoc or American Well.  (This functionality should be there within a couple months.)

After that: the architecture can be put to use for other sorts of screenings.  Cerino says Microsoft would welcome hearing from other expert partners who want to help build tools for other diseases.

But here's the real power of this tool: It has the potential to provide "epidemic intelligence in real time," according to Kellermann, citing a recent Science editorial coauthored by IOM Director Harvey Fineberg, entitled Epidemic Science in Real Time.  By collecting a limited data set (including symptoms reported as well as zip code, age and gender), Microsoft would be able to map progress of any epidemic or public health event -- not just H1N1, but also a foodborne illness outbreak, a potential bioterror incident, etc., etc., replacing the shoe leather approach, says Kellermann, represented by the hole in sole of the shoe proudly displayed in the logo (above) of the CDC's Epidemic Intelligence Service.  If people opt in to share de-identified data, this tool has the potential to put Google Flu Trends to shame.

Look for more Microsoft partner links at the end of tools like this one; if you want to partner with Microsoft and have an idea for an online interactive questionnaire powered by a peer-reviewed algorithm that can appropriately direct people to your service, please get in touch and let's talk.

Kudos to David Cerino and his team for blending a contribution to the public health and the broadening of the Health Vault brand simultaneously -- and look for plenty of links to this new site on Bing, MSN, MSNBC and other Microsoft web properties.

So: What other tools would you like to see tied into this architecture?

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Whither meaningful use of the certified, interoperable EHR?

Paul Roemer asks:

Have you ever been a part of a successful launch of a national IT system that: 

• required a hundred thousand or so implementations of a parochial system?
• has been designed by 400 vendors?
• had 400 applications based on their own standards?
• has had to transport different versions of health records in and out of hundreds of different regional health information networks?
• needed to be interoperable?
• could have resulted in someone's death if it failed?

Me neither.

The challenges are many, yet many health care systems already are, or soon will be, moving to implement pieces of this national system.  Are they motivated by the HITECH Act promise of up to $44,000 per physician for meaningful use of a certified EHR?  Perhaps, but that won't cover the cost.  The real value is in the ability to manage a patient's care effectively, efficiently and seamlessly across practice sites and, beyond that, to learn from population-level data. 

The federales already know this -- check out the recent All Things Considered piece on the Medicare claims database.  The aggregators of de-identified data putting it to secondary uses already know this, though their work may be made more complicated by the new HIPAA and Son of HIPPA rules out from HHS and FTC.  Some health systems know this, and are prepared to match the federales' incentive payments to docs who get on the bus (adding some Stark, fraud and abuse and tax issues to the already-heavy load of considerations).

Health care provider systems are ready to get with the program, but may need some guidance in negotiating the regulatory and operational minefields as they move to implement EHR systems. 

If you're part of a system looking for some ground-floor planning and strategic thinking on this thorny set of issues, please get in touch with Paul or me.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Dr. Ben Kruskal, Director of Infection Control at Harvard Vanguard Medical Associates: Conversation with David Harlow about H1N1

The kids are back in school and it's time to pick up the H1N1 conversation with Ben Kruskal, MD, PhD, Director of Infection Control at Harvard Vanguard Medical Associates.  In today's installment, we look ahead to the fall and winter, and discuss the planning that will see us through the season.  Dr. Kruskal touches on H1N1 crowding out seasonal flu in the southern hemisphere during its winter season, and on the likelihood that H1N1 vaccines will only require a single dose, and not two, as had been anticipated.

Our conversation runs about 15 minutes and is available for download/podcast.

Update 9/20/09: The transcript of my conversation with Dr. Ben Kruskal about H1N1 is available at the link and below.

Our earlier conversations are available here and here.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 

Interview of Ben Kruskal, MD, PhD

Director of Infection Control of Harvard Vanguard Medical Associates

September 17, 2009

David Harlow:  This is David Harlow on HealthBlawg, and I’m speaking today with Dr.  Ben Kruskal, Director of Infection Control of Harvard Vanguard Medical Associates.  Hello Ben, how are you?  

Ben Kruskal:  I’m very well, David.  How are you?  

David Harlow:  Very well, thank you.  So, Ben, we last spoke in the spring as people were just trying to get a handle on swine flu, as the infection was spreading, and as various groups were trying to get ahead of swine flue.  So here we are 4, 5 months later and I’m interested to hear: From your perspective, have things gone as you might have expected 4, 5 months ago?

Ben Kruskal:  I would say they have.  We continued to see some H1N1 disease gradually winding down from the spring through the summer, things were quite quiet through the summer and are still relatively quiet, although we’re just beginning to get the intimation of maybe things ticking up again.

David Harlow:  OK.  I was looking at some Massachusetts Department of Public Health figures and it looked like there was a bit of a spike in late May/early June, does that track with anything that you saw?  

Ben Kruskal:  That’s exactly right.  What we saw was seasonal flu winding down through April and then at the end of April and beginning of May, a big spike well above the normal levels for that time, with a gradual trail coming down through May, June and trailing of back to sort of true in between season levels in the middle of July or so.  

David Harlow:  Okay, so as we look ahead to the following school year, here we are end of summer, college kids are back at school, school kids are back at school, have you seen any uptick in cases what with folks back into school and back in closed quarters with other young folks?  

Ben Kruskal:  We’re not seeing a whole lot of cases here yet but there are certainly reports from all over the country of some outbreaks, localized particularly in the college and the university world.  

David Harlow:  Do you attribute that to a dumb luck or has there something else been going on locally that may be helping in mitigating this spread?  

Ben Kruskal:  I don’t know that there is anything we can easily attribute it to. I know that there has been some earlier activity in the southeast which may have something to do with an earlier start to the school year for school age kids, they start a week or two at least before we do, so that may explain some of it.  

David Harlow:  Right, so we may see that on a rolling basis, just as school gets underway.  

Ben Kruskal:  Exactly.  

David Harlow:  So we’re looking forward to seeing a vaccine in the near future and I’m wondering whether you can tell us anything about the vaccine, and about whether there has been any change in characteristics of the virus overtime.  And also – again, back to the vaccine - there has been varying information about whether people will need one dose or two for the H1N1 vaccine.  

Ben Kruskal:  Well, let me speak first to the issue of the virus changing.  Buy and large, it seems to be fairly stable in its behavior through the flu season in the southern hemisphere. Most of the reports were that it was very similar to what we had seen here. There are a few locales where there has been a higher proportion of severe disease, just as it was in Mexico in the very beginning of the outbreak, and we really don’t understand why that is the case.  

David Harlow:  Have any theories been floated or any ideas about why some people are hit harder by this?  

Ben Kruskal:  There are a few theories out there.  One is that the areas that are harder hit may have populations with particular genetic susceptibility to the virus.  Another possibility is that in certain locales there are other microbial pathogens, other co-infections that could potentiate the H1N1 and cause it to become more severe.  Yet another theory is it relates to lower immune defense because of malnutrition.  I don’t think that theory flies quite so well as the others because it really doesn’t correlate terribly well.  The severity of disease doesn’t correlate terribly well with economic indicators.  

David Harlow:  So we’re looking forward now to the fall and winter and looking at H1N1 layered on top of the seasonal flu; would you expect there to be a more severe flu season because of the added ingredient to the H1N1?   Ben Kruskal:  Well that is certainly a big question mark.  The experience that we have to guide us from the southern hemisphere seems to be that by and large the typical flu seasonal flu strains were simply displaced by the novel H1N1.  And so rather than seeing the 2 or 3 circulating strains that we normally see in a typical flu season in the southern hemisphere, the vast majority of flu that they saw was the novel H1N1.  

David Harlow:  Interesting, so it’s sort of crowded out others?  

Ben Kruskal:  Right and that’s been a feature of previous pandemics as well, so it’s not entirely surprising.  So what we anticipate, most likely, is that we will have an H1N1 outbreak - it will last as long as it lasts.  It will quite likely occur earlier than typical flu season and hopefully after that’s over, it will be over and we won’t have any more flu for another year.  

David Harlow:  Right, but in the meantime, there has been a lot of contingency planning done both by health care providers, schools, employers even looking forward to what they can do to mitigate interruptions in operations in case there is greater incidence of this flu.  Are there any particular plans that you can point to that seem to be well thought out and executed on the health care front?  Thinking particularly about the issue of vaccinating health care workers, I remember reading in the past few weeks about some health care providers who have said that they don’t want to be inoculated and I’m wondering whether that is something that should be left to the individual provider?  

Ben Kruskal:  Well, you have to probably start with the trends in seasonal flu vaccination for health care workers.  Flu is a relatively unusual virus in that it’s serious enough to cause disease that’s quite a problem for many patients but it’s not serious enough that everybody who gets it won’t come to work.  So if you have dedicated health care workers who get sick and still get into work, so they don’t strand their coworkers and their patients, they are infecting their patients.  And so as a result there has been a strong move over the past 5 years or so to increase health care worker vaccination against seasonal flu and actually in many health care organizations that’s made a requirement of employment and that’s a trend that has been accelerating rapidly with the H1N1 outbreak.  For example, here in Massachusetts, the Commissioner of Public Health issued a public health order mandating that all health care organizations offer seasonal flu vaccination and pandemic flu vaccination when relevant to all of their staff and that staff who don’t want that vaccine have to actively decline.  

David Harlow:  That stops short of mandating it, so someone could still decline the inoculation and come to work.   Ben Kruskal:  That is true and there are certainly some health care organizations that have been experimenting with making it a firm condition of employment, allowing only medical exemptions.  

David Harlow:  Other than the Department of Public Health Commissioner’s order there has been a lot of activity at the Department of Public Health and I’m wondering if you could comment on some of the other actions taken there and whether those have been moving things forward in your estimation.  

Ben Kruskal:  I think so; I think Massachusetts is ahead of many states in terms of pandemic planning.  The Department of Public Health has been working on this for at least 8 or 9 years and as a result I think we have plans that are considerably more mature than in many other areas of the country.  That being said, you still want to be fully prepared but the Department I think has been coping very, very well and really is serving something of a model for other states.  

David Harlow:  Could you give us an example of one of the parameters along which the Department has done some good advanced planning or perhaps something from your experience at Harvard Vanguard?  

Ben Kruskal:  Well, I think the Department has done very well establishing communications channels both to healthcare providers and to the general public.  They set up the 211-information line.  They have made epidemiologists available to answer questions during the outbreak; they really staffed their communication center quite heavily so that people were available.  They were holding frequent conference calls with various constituencies to keep us up-to-date.  They worked very, very hard at communicating and I think they did a very successful job of it.   

David Harlow:  As you’re mentioning these various items I’m remembering that Dr.  Al DiMaria, the state epidemiologist, also put up a YouTube video on how to wash hands.  

Ben Kruskal:  Absolutely.  

David Harlow:  So they are really firing on all cylinders there.   

Ben Kruskal:  That’s right.  

David Harlow:  Are there other areas of concern that you see ahead of us?  We were talking about health care workers refusing inoculations, are there other potential areas of concern that we need to be thinking about?  

Ben Kruskal:  I think we need to be really focusing everyone’s attention - both health care’s attention and the public’s attention - on basic infection control measures.  And washing hands because, juvenile as it may seem, really is a major contributor to decreasing transmission of many respiratory illnesses.  And there have been several studies in the last few years that have really demonstrated a clear impact of improved hand hygiene on transmission, for example within a household.   

David Harlow:  Okay, and that’s something that’s easy to do and have a real impact.  

Ben Kruskal:  Exactly.  You don’t need a college degree.  

David Harlow:  Anything else that you would like to highlight as we continue this experience?  

Ben Kruskal:  You raised some questions earlier about the vaccine, which we really haven’t gotten to.  The vaccine in the early trials that have been reported performed much better than expected.  Given that it’s a relatively new strain that most young people have not had any prior exposure to this strain or related strains and that therefore there is little preexisting immunity, it was expected that we would need two doses of vaccine, one to sort of immunologically prime us and a second to give us a full boosting to get really good levels of antibody.  And surprisingly in all of the major vaccine trials that have been reported in the last few weeks, a single dose has been sufficient to generate very good levels of protection - better than many seasonal vaccines.  And so we’re feeling very hopeful that we’ll be able to get a lot more people vaccinated with the supply that we have.  

David Harlow:  And the supplies are coming in or when are they doing?  

Ben Kruskal:  They are nominally due in around the middle of October. Secretary of Health and Human Services Sebelius has said that they may be able to mobilize some doses even a week or two before that.  We expect that we will start with small shipments and gradually swelling shipments and then get a steady supply over a period of many weeks.  

David Harlow:  And do you see looming difficulty in getting folks in to have both the seasonal and H1N1 inoculation?  

Ben Kruskal:  My experience with seasonal flu has been that the vaccination rate in any given year depends very heavily on media attention.  And one or two well publicized cases or especially deaths can really spur vaccination quite a lot.  So I think it’s going to depend an awful lot on what the public perception is and what the media’s shaping of that public perception is.   

David Harlow:  Well, we’ve certainly been hearing a lot about H1N1 and I suppose people will be getting their seasonal flu vaccines as well as a result.

Ben Kruskal:  Right, it certainly has generated a larger than usual interest in seasonal flu vaccine so far this year.  

David Harlow:  Okay, well thank you very much.  I’ve been speaking with Dr.  Ben Kruskal, Director of Infection Control of Harvard Vanguard Medical Associates here in the Boston, Massachusetts area.  Thank you again.  

Ben Kruskal:  It’s a pleasure David.