HealthBlawg

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

Blawg Review Bucket List Tour Hits Beantown

"Ed." -- the anonymous editor of Blawg Review -- is on the road again.

Criss-crossing the continent, Ed. has been popping up here and there.  Follow his peregrinations via @blawgreview on twitter and at Blawg Review. 

Jay Shepherd (@jayshep), Chris Mirabile (@cmirabile) and I responded to Ed.'s last-minute tweetup call to "get gruntled" last night (a wry reference to Jay's blog) at a Beacon Hill watering hole.  (Ironically, or perhaps by design, we did not meet at the more famous watering hole nearby, "where everybody knows your name.")  Waitstaff in what I can only describe as post-modern attire, and a bachelorette party further back in the bar, did not distract us from engaging in a close examination of the state of the blawgosphere, and the nature of being anonymous, with Ed.  (He introduced himself: "Hi, I'm Ed."  Really.)  Check out the photographic evidence -- that's Jay and me bellying up to the bar with Ed.

Despite Ed.'s invitation to get "way gruntled," the libations, the oddly-attired denizens of the watering hole, and a host of other factors, we managed to part ways at evening's end each under his own power, and without my having to add any transgressions to the bucket list du jour: misdeeds to repent for as we approach Yom Kippur, the Day of Atonement, which begins at sundown tonight.

May you all be sealed in the Book of Life.  Ed., I really don't know how that works for the anonymous among us.  Good luck.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HITECH Act security breach rules now effective; federales give a six-month pass. Now's the time to kick compliance efforts into high gear

Two key Son of HIPAA rules mandated by the HITECH Act are now effective.  Both the FTC and HHS have finalized their security breach notification requirements and have assured the regulated community that they have six months to get their collective houses in order.

Please take the time to peruse both the HHS Son of HIPAA security breach notification rule and the FTC Son of HIPAA security breach notification rule.  I discussed the impact of the breach notification rules and their enforcement when they were issued as "guidance" and draft regs in April at HealthCamp Boston and will be posting more information about them in the near future.

A few points to consider for now:

• The HHS breach notification rule layers encryption standards -- how to render health information "unusable, unreadable or indecipherable" -- for data at rest, data in use and data in motion, on top of the HIPAA privacy and securty rules.
• Encryption is not required, but a security breach with respect to non-encrypted data triggers public notice requirements (i.e., alert the media) in addition to data subject notice requirements.
  
• The FTC rules widen the net, imposing HIPAA-"covered-entity"-like obligations on business associates including, e.g., PHR vendors and other non-covered-entity repositories of health information. 
• As an aside, greater regulation of other business associates under HIPAA will be effective in February; business associates will have to implement policies and procedures similar to those now required only of covered entities.
• Enforcement will be ratcheted up after six months.  Greater sanctions are available for regulators to impose, and the FTC is a tougher enforcer than HHS has been on the HIPAA front to date.

With all this in mind, now is the time to examine policies and procedures, update them to comply with new rules -- Son of HIPAA rules and related/overlapping FTC Red Flag Rules (effective November 1) and state data security rules -- train staff to follow the policies and procedures consistently, and communicate commitment to these standards to your various consituencies: patients, other health care providers, business partners, etc. 

The Harlow Group LLC stands ready to assist covered entities and PHR providers in assessing the regulatory landscape, conducting an audit of current policies and procedures, and moving from a gap analysis to developing a fully compliant program and staying ahead of the curve going forward.  Please be in touch to learn more about our approach.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

David Harlow quoted on retail clinics' future direction in Supermarket News

The future of retail clinics was the subject of a recent article in Supermarket News.  In speaking with managing editor Christina Veiders, I noted that there is a real need to diversify the services offered by retail clinics -- in whatever the setting -- and partner with established health care brands (e.g., local health systems), since their growth and volume have not kept pace with early projections.  This creates a new patient-marketing channel for health systems, too, and some have been quite successful at it.

For more on retail clinics, please see the presentation I gave at the Retail Health Clinic Summit this past spring.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Health Reform: The Impossible Dream?

Over the weekend after Obama's health reform speech to a joint session of Congress, only about one-third of Americans surveyed said they understood the President's plan.  Of those who actually heard his speech, more than half said they understood it, but they got tripped up on questions about the details, according to a poll conducted by Siegel+Gale via Wego Health.  The poll results show in great detail how little most people understand about this issue, despite the fact that the President -- along with everyone else in Washington, and most people I deal with on a daily basis -- has been spending an awful lot of time talking about it.  (Hat tip to Jane Sarasohn-Kahn at Health Populi).  The detailed survey results may help Obama's team fine-tune the message to the public at large.  My guess is that many, many folks are equally ill-informed about most other things in life -- the survey only asked about health reform ....

Even if people understood the message clearly, the bigger question is whether they would support the proposals being bandied about. 

(As an aside, It's worth noting that as of this writing there is no piece of legislation that is "the president's plan" and the Senate Finance Committeee's "Chairman's Mark" (until last week considered by many to be the last best hope for a vehicle for health care reform) was released in form apparently designed to appeal to Republican members of the committee, who nonetheless spurned it; over 500 amendments have been offered (see September 19, 2009), and they will be considered in the very near term.  The process has bogged down -- not irretrievably, one would hope, but certainly at the expense of clarity, swift action and Congressional and Presidential attention to other pressing matters.)

The short answer is:  Well, it depends.  The longer answer: fine-tuning the message would really help.

A couple of points to expand on these cryptic answers:  Since most people in the U.S. have some form of health coverage and are largely satisfied with it, we face what is known as "the endowment effect."  In brief, if you own something, you tend to overvalue it.

To quote James Surowiecki, writing in the August 31 New Yorker:

What this suggests about health care is that, if people have insurance, most will value it highly, no matter how flawed the current system. And, in fact, more than seventy per cent of Americans say they’re satisfied with their current coverage. More strikingly, talk of changing the system may actually accentuate the endowment effect. Last year, a Rasmussen poll found that only twenty-nine percent of likely voters rated the U.S. health-care system good or excellent. Yet when Americans were asked the very same question last month, forty-eight per cent rated it that highly. The American health-care system didn’t suddenly improve over the past eleven months. People just feel it’s working better because they’re being asked to contemplate changing it.

Second, there is the "status quo bias;" most people are inclined to leave well enough alone.  People believe we're talking about a budget-neutral, zero-sum health reform game, and since the President has promised to extend coverage to the uninsured, most insured folks believe that will be at some cost to them.  Again, Surowiecki:

Still, just because you can’t change human nature doesn’t mean you can’t change health care. The key may be to work with, rather than against, people’s desire for security. That’s surely one reason that Obama has consistently promised people that if they like the health insurance they currently have they can keep it. This promise will make whatever reform we get more inefficient and less comprehensive, but it also assuages people’s anxieties. It might even be possible to use the endowment effect and the status-quo bias in the argument for change. After all, although people tend to feel that they own their health insurance, their entitlement is distinctly tenuous. Because it’s hard for individuals to get affordable health insurance, and most people are insured through work, keeping your insurance means keeping your job. But in today’s economy there’s obviously no guarantee that you can do that. On top of that, even if you have insurance there’s a small but meaningful chance that when you actually get sick you’ll find out that your insurance doesn’t cover what you thought it did (in the case of what’s called “rescission”). In other words, the endowment that insured people want to hold on to is much shakier than it appears. Changing the system so that individuals can get affordable health care, while banning bad behavior on the part of insurance companies, will actually make it more likely, not less, that people will get to preserve their current level of coverage. The message, in other words, should be: if we want to protect the status quo, we need to reform it.

Fine theoretical underpinnings for the notion that health reform can be seen as both anathema to, and a sine qua non of, the status quo ... but that brings us no closer to the goal of delivering a clear message to the general public.

As I've said before, the President's initial approach to this whole thing ("I've told you what's important to me.  Send me a bill that I can sign.") made much more sense to me.  Despite being 100% right on the money in most of his commentary on the GOP's non-reality-based critiques of reform plans in play, he's now mired chest-deep in the details and in the political tug-of-war.  That's a mistake, in my opinion.  I'd like to see him pull back to the half-dozen or so basic health reform principles that he articulated early on.  Yes, I know it's more complicated than that, but in this highly-charged atmosphere, trying to explain all of the details apparently leads inexorably to inanities about death panels and the like, so we're far better off focusing on the broad outlines in public messaging. 

What do you think?

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Paul Grundy, MD, Patient-Centered Medical Home champion, speaks with David Harlow about the model and the challenges and opportunities ahead

Dr. Paul Grundy is on a mission -- a mission to promote the patient-centered medical home model that he has been instrumental in developing and rolling out, in his dual role as Director of Healthcare, Technology and Strategic initiatives for IBM Global Wellbeing Services and Health Benefits, and President of the Patient-Centered Primary Care Collaborative.  I had the opportunity to speak with him earlier this week, at the end of a day he spent in Washington, D.C., hard at work on this continuing mission.

The audio file of my interview with Paul Grundy (about 30 minutes long) is available for download/podcast.  A full transcript is at the end of this post (and in the linked Paul Grundy interview transcript).

I use the word mission because Paul frames the need for dissemination of the medical home model in terms of a transformational change in the nature of the covenant between doctor and patient -- not simply a reformation.  In his view, reformation without transformation creates as many problems as it solves: e.g., the primary care shortage exacerbated by increased insurance of the population at large in places like Massachusetts.

The Patient-Centered Medical Home model -- described more fully in materials from the Patient-Centered Primary Care Collaborative, and TransforMED, an affiliate of the American Academy of Family Physicians -- relies on a shift in physician compensation from a fee-for-service focus to a patient management focus; from an episodic focus to comprehensive, relationship-based care.  It's been implemented in over 100 pilots around the country.  Denmark learned about the model here in the U.S. decades ago and has implemented it fully across the country's health care system, shuttering most of the acute care hospitals in the country in the process.  Pilots in the U.S. include Geisinger's, which Grundy says has been remarkably successful, yielding an ROI of over 250%, including a 12% reduction in ER utilization, a 20% reduction in hospitalization, and a 48% reduction in rehospitalization.

Technology is an important part of these efforts and savings.  Even given the potential high cost of technological solutions and Health 2.0 tools, the costs pale in comparison to the $1 million-a-bed cost of hospital construction, let alone hospital staffing and other operating costs.

The key to catching up with places like Denmark and Spain, and systems like Geisinger, Intermountain and the VA, says Grundy, is the recognition and implementation of medical home-compatible payment systems by CMS, since it controls half of the country's health care spend, and providers march to CMS's tune.  Without that buy-in, it has been difficult to promote the model beyond integrated delivery systems, large group practices, and pilot-project-funded solo and small practices.

CMS announced Medicare funding for medical home program demonstrations in the states the day after Paul was in Washington earlier this week -- coincidence? I think not! -- and the concept is built into legislation percolating its way through Congress.

The model is a critical component of future improvements to our health care system; Paul Grundy and the patient-centered medical home both deserve our close attention.    

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HealthBlawg :: David Harlow’s Health Care Law Blog

Interview of Dr. Paul Grundy

Director of Healthcare, Technology and Strategic initiatives for IBM Global Wellbeing Services and Health Benefits

President of the Patient-Centered Primary Care Collaborative

September 15, 2009

David Harlow:  Hello, this is David Harlow on HealthBlawg, and with me today is Dr. Paul Grundy, who is the Director of Healthcare, Technology and Strategic initiatives for IBM Global Wellbeing Services and Health Benefits.  He is also President of the Patient-Centered Primary Care Collaborative, which is a group of large employers and primary care physician associations.  Dr. Grundy has years of experience in government and in the healthcare industry and I am happy to welcome him today to HealthBlawg.  Thank you, Dr. Grundy, for being with us.

Paul Grundy:  Thank you for inviting me; it's a pleasure to be with you.

David Harlow:  Well, I would ask if you could start off with a brief introduction on your experience with the patient-centered medical home initiative at IBM.  What is it exactly?  When you use that term what do you mean?  How long has this been a project of IBM’s and what kind of impact is it having both in terms of health status and cost savings?

Paul Grundy:  So the concept of a change of the covenant between the buyer of healthcare and the provider of healthcare is at least some years old in reference to the concept of better primary care - more integrated, more comprehensive primary care.  We as buyers of care really reached a conclusion that if we were going to really shift the curve or bend the curve as they call it now and we are going to begin to add the kind of value in the doctor-patient relationship that our employees were asking us to do, that it would take a transformation across the ecosystem, it would really take a change of covenant between the buyer and the provider of care, i.e., aligning payment at the macro level in exchange for micro-level transformation of practices to deliver better care.  

So our employees -- or just in general, the patients -- what they really want, they want convenience, they want access, they want comprehensive care, they want relationship-based care.  What they get now instead of that is they get episodes of care and what we buy is an episode of care, so: I can buy the kind of care that allows me to get pretty good amputation for my diabetic, but I can’t buy the kind of comprehensive integrated care that prevents my diabetics from needing an amputation -- is sort of the line I have been using for the last four years, and it's still true.  So we thought about that long and hard at IBM and certainly many other companies as well and some places have in essence created onsite facilities to do this, but since we have 60 percent of our employees that are scattered in every zip code and we really wanted to be equitable for all of our employees whether they happen to live next to a large IBM site or not.  We really decided to take a different tack and that was to begin to have a conversation with the folks who should provide comprehensive care, i.e., the primary care providers, which do that in most societies, and see if there was a way we could create a movement towards and ability for us to buy that kind of care across the spectrum.

So I guess about three years ago now we had 47 large employers that met with all of the primary care organizations and out of that meeting was born the joint principles of the patient-centered medical home, when the buyers said to the providers you need to agree on a set of principles around the concept of more robust, more comprehensive, more integrated care.  So that’s sort of the birth of the idea and the partnership between and buyers and the employers.  It's now grown much larger, with well over 600 organizations that are part of it including hospitals, all the national health care plans, many of the large consumer groups, the employer associations and I think there is a total of 19 medical specialty groups that have endorsed the concept, etc.  So it's grown to a rather large organization that’s really fundamentally trying to drive change towards more comprehensive primary care.

We also are a global employer, as many large companies are, and we noted that in many societies, those who have really integrated comprehensive robust primary care as the basis of their health care delivery system seem to be happier, and obviously the healthcare costs are twice as much in our society as they are in any other society -- you know that’s been quoted many times, but it's true.

David Harlow:  Right.  You mentioned the growth of the participation in the collaborative but from where I sit my perspective is that actual implementation of patient-centered medical homes has not been quite so wide spread and there is certainly a distance to go. I am wondering: From where you sit, how do you see this idea translating to the population at large? Or on what time frame?  Are the demonstrations that are included in some of the health care bills wending their way through Congress an appropriate right next step from your perspective, or do we need to take bigger leaps at this point?

Paul Grundy:  Well, the original concept when we first met after about a year of sort of sorting out our thoughts and directions in the partnership between the buyers and the providers, we asked the national health care plans into the room, because companies buy their health care through the 5 or 6 national health care plans, and some local ones as well, and we sort of thought probably the best way forward would be to really design some pilots around the concept, to kind of kick the tires to prove it out in various communities around the country, and so that led to a number of pilots beginning to evolve in the commercial marketplace.  Some legislation was passed for it to occur in CMS although they haven’t kicked off yet, but there are many pilots that are multi-stakeholder pilots with many health care plans that are rolling out.  I think at last count there were a little over 100 that I counted rolling out around the country, of which a dozen or 20 or so are really pretty far along and pretty robust in terms of the scope and the size of the pilots.
But the concept was to build into these pilots pretty rigorous analysis, to look at them academically, to kick the tires with them, to see how the results would look and then, from what we learned, to move forward.  Some of results are out on some of the early pilots at the first year and into the second year, and what we’re seeing consistently across the dozen or so that are out is that indeed better upstream care -- i.e., better care coordination, better primary care, better prevention, better access into the primary care provider’s office -- results in significant decline in the utilization of emergency rooms and hospital beds.

David Harlow:  Yes, I saw some press recently about Group Health of Puget Sound --

Paul Grundy:  That’s correct, that’s one of the early pilots, they now have data for two years; they have published for the first year.

David Harlow:  Yeah and so they and a number of other sites have been experimenting with this.

Paul Grundy:  That’s correct.

David Harlow:  Do you see differences across different pilot locations in the model being used, is there significant variation in the models being rolled out and tinkered with?

Paul Grundy:  Well there is variation in what’s looked at, there is variation in how it's rolled out.  I think what’s a pretty constant is just simply looking at applying better care coordination, on more robust primary care in an ambulatory setting, resulting in less need for hospital beds and emergency room utilization.  What’s been looked at has been different.  For example, in North Dakota they looked at the disease diabetes with a much more coordinated approach to the care management of diabetics, and they resulted in about a $500 a year savings for each of the patients which they shared with the practices.  That resulted in moving from a pilot to an actual roll-out across the state as we speak, which is what’s happening with many of these pilots.  The same in Geisinger.  Geisinger did better care co-ordination, better upstream care looking at a range of chronic diseases for elderly people, and what they discovered was a 48 percent reduction in re-hospitalization, a 20 percent reduction in hospitalization, a 12 percent reduction in ER utilization, an ROI of 251 percent, significant savings and again what they have - the lesson that they’ve learned from that is that, they are going to now move beyond the pilots stage and roll it out across their system.

The same with Intermountain.  Intermountain did it in a number of locations, saw the same kind of results. Those are integrated systems, and what we’ve seen in individual practices across the country -- and there’s probably been over a hundred that I’ve visited – Javier is an example: he is a pediatrician down in Florida, single physician, 41 percent Medicaid and again better care co-ordination, better empowerment, better education of the patients, better access to the primary care team resulted in going from an average of about one asthmatic admitted to the hospital a week to none in 14 months, and that, when you carry that beyond United States and look globally at places that are really doing this, who are 10 or 15 years ahead of us, is exactly the pattern we saw.

I mean in Denmark, for example, it is a rare event now to hospitalize patients for chronic diseases because that’s managed with better care co-ordination, better primary care, better care integration in a medical-home-type environment including, as migration occurs out, actually links to Wi-Fi equipment monitoring at the home, that sort of thing.

David Harlow:  I was just going to ask about how this model interacts with some other sorts of initiatives, new developments.  People talk about Health 2.0, for example, and you mentioned the Wi-Fi monitoring, and interactive connections.  Do those sorts of tools help to enable the demonstrations to work more efficiently and effectively or are they too expensive in some cases?

Paul Grundy:  No they are not.  In many cases most of those kinds of things are in fact much less expensive than you know, than hospital rooms, right? I mean, a hospital is about the most expensive place you can treat some of these diseases -- and by the way it's dangerous, it is not a place you want to go --

David Harlow:  There’s sick people in hospitals --

Paul Grundy:  Yeah, you have sick people in hospitals and people get sick in hospitals, it's an unsafe place, so what I think is happening, frankly, and I think it is a 2.0 kind of issue, we really had a juncture in time when the docs will have the kinds of tools -- and we’re already beginning to see them roll out -- that really empowers them from an outpatient sort of vantage point, with the control center really at their desk that has real information provided to them so, so some of this care, can and is done in it continuously and he has done virtually in which, in which you begin to have the kind of data flow that will empower the physicians minds the way X-rays empower their vision.I mean it's that kind of transformation and in some places it's further along than others, some places in United States it's further along than others and if you look globally there are places where again, like the Danish model -- they have gone from 155 hospitals down to 25 -- it's just, again, a rare event to have the kinds of diseases that can be monitored remotely, and can be monitored with a more integrated approach to care, to have to put them in a hospital where they are in danger.

I mean it's a phenomenal change and that’s exactly what the example of North Dakota was or what the example in Colorado was or in North Carolina.  In North Carolina, the State of North Carolina and Community Care North Carolina began to focus on better care coordination integration and resulted in, I think it was, a 44 percent reduction in the number of patients that were hospitalized for asthma, the same story that we talked about, and these aren’t integrated systems by any stretch of the imagination; these are folks that are eligible for Medicaid.  And the same in Colorado: very similar results within the Medicaid population with, again, better upstream care resulting in lower downstream cost.

David Harlow:  Are there any particular sets of incentives that you can generalize about that are proven to be most effective in yielding desired results?

Paul Grundy:  I think aligning payment around what it is you want to buy, right? I mean, we currently align payment around buying stuff; if a bill is submitted for doing stuff we pay for it.  What we find is that when you begin to align incentives around paying for care coordination, care integration -- for example in the United States most docs don’t have a clue who their patients are even and they don’t have a sense of responsibility for making sure that all of them have their colonoscopies done or their breast exams done or their immunizations done because here there is no sense of: I am responsible for that.

So you need to align that. So one of the alignments that other societies have done, and other integrated systems have done or the VA in United States has done is that they basically incent the patients and the docs and by aligning them in a location where both agree that that’s their home, that’s where there medical records are and somebody is responsible, they have got a target on their back to make sure they don’t die of breast cancer, because they are getting their breast screens, right?  I was visiting a clinic in Spain and I saw a - I went in to the doc’s work room and they were three names on the board and I said to one of the docs there, who are those names and she said well, those are three women in the community that after sending them an e-mail, after mailing them, after phoning them, they still haven’t got their breast exam, so we are sending a car out today to make sure that it wasn’t for our failure to make sure that they have got their screening exams, that they die of breast cancer.

That kind of community-based responsibility in aligning payment around that I think is key for a system to really work; I know we have the most mal-aligned system in the world --

David Harlow:  Yes, it clearly needs a lot of work --

Paul Grundy:  That’s why we are twice as expensive as anybody in the world. One part of the reason, it's kind of like the Olympics a few years ago, where we got the very best players in the world and we have a really good well trained physicians here.  We have really excellent hospitals, medical schools etc., and we put them on the court, the basketball players, and we got whipped – right? – by somebody, I can’t remember who it was, but mainly the fact was we didn’t play together as a team, we couldn’t throw the ball.  I mean, that’s what happens every day in our health care delivery system, we have nobody, nobody, coordinating care.  I mean somebody can have five specialists and you know one’s doing the exact opposite of what the other is doing and nobody is talking to each other, right?; it’s really dangerous.

David Harlow:  Right. So you’ve alluded to some of your experiences and what you have seen in other places around the world and I know you had a lot of other experiences around the world in earlier parts of your career and I am wondering which of these examples that you’ve seen or other experiences from your past do you particularly draw on and look at in developing this model further.

Paul Grundy:  Well, this is not even around the world, it's here as well.  I mean, one of the major systems here in United States that's really driven a lot of inefficiency out of the systems - the  Veterans’ Administration - they moved from a basically hospital-based system to an outpatient, primary care based system with clinics, 700 or so locations around the county, really with the focus on comprehensive integrated care and just drove tremendous efficiency and resulted in the highest patient satisfaction of any of our health care delivery systems in the United States.

A phenomenal change given my experience in training in their hospitals earlier in my career and if you look at, and if you look at other models of care here like Geisinger and Kaiser, some of the integrated systems, they really do well - the statistics show that if you are in a integrated system where somebody just pays enough attention to make sure that you take your aspirin, that your blood pressure is controlled and you take your Lipitor, or your lipid lowering agents that you know you have one third less likelihood of having a myocardial infarction than somebody age- adjusted in a system where nobody is coordinating your care.  It's a phenomenal difference.  I mean we have twice as many heart surgeons and heart surgeries in this country and I think you know part of the reason why we need to is that we fail to provide robust primary care and prevention.  

If you want to look globally at systems that are really taking this model I would have to say first that in my looking and studying and reading about this, it's really an American model that sort of went global.  It's kind of the like the Japanese model that came back to America and when they asked where it came from they said it’s the Wharton school of business, right?  The Danes came here under a Harkness fellowship and the Commonwealth Fund, studied what was going on at Kaiser, read the pediatric literature about medical home kind of went back to Denmark and designed a system and they really focused on that and you know they are one of the few countries in the world --

David Harlow:  They actually did it?

Paul Grundy:  They actually did it: one of the few countries in the world that actually has a curve of cost trends downward, I mean downward - not go-broke upward like our system is - downward and again it's not very hard, it's not very difficult, it was putting money into the front end of this system developing a robust system of prevention and primary care, putting the technology and the tools to really do more effective management at the level of the doctor-patient relationship in the primary care delivery system.  Spain is gone from being 19th in the world to fourth with the same transformation; in the meantime, according to the study in Health Affairs that I’ve read we’ve gone to 19th of 19 developed economies, dead last.

David Harlow:  Yeah so it’s troubling. So do you see an opportunity and a role for government-led health reform along these lines? What you have been describing to me is really private-payor-driven and integrated-delivery-system-driven developments in the direction of the patient-centered medical home. Is the job done? Is the job close to being done? Do we need the government to step in?  How can it help?

Paul Grundy:  Well to be frank and blunt, absolutely honestly, that’s the kinds of dialogue we’ve had at the level of the White House in the recent roundtable where we were discussing this and in fact I’m in Washington today visiting some of the folks on the Hill about this. Why?  Because how health care is delivered in our country is so dependent on how CMS buys health care, I mean that’s 50 percent of the spend --

David Harlow:  Sure, as the biggest buyer, yeah --

Paul Grundy:  Yeah, so when we try to buy health care and we don’t buy it in a model of health care that’s around how CMS buys it, it makes it very difficult for us, the non-government buyer.  We can buy it in integrated systems but that only accounts for about 6 percent of the places where we can buy, right?  Much of the country, even if I tried I couldn’t buy the kind of care that’s available at Geisinger, I just can’t buy it --

David Harlow:  Right, let’s have the systems in place --

Paul Grundy:  So we have to help virtualize what those guys do, look at what they do and virtualize it -- that’s Health 2.0, that’s, taking a primary care doc and helping him have the kinds of tools that would allow a simple registry -- the ability to track diseases -- the ability to be compensated for tracking diseases, the ability for payment reform to occur, where they actually get paid for having an e-mail, an asynchronous conversation with my patients to do follow up, they are only paid now for face-to-face encounters and the reason why they are paid that way is because that’s how Medicare buys, right?  That’s, that’s my dilemma, that’s all of our dilemma.

David Harlow:  Right, and there are certainly demonstrations looking at bits and pieces of this, and there is hope …. For example, in my home state, Massachusetts, we’re looking at a global payment transition over the next five years.

Paul Grundy:  Yeah, Massachusetts is doing some very exciting things and I think there is quite a bit of interest in the medical home there.  I was just recently meeting with some of the leadership on this in the state and there is a lot of excitement on the one hand, and the other hand they are closing primary care training programs at Harvard.  It’s very interesting, but what our system values, what they pay a lot of money for, is procedures and not for the kinds of relationship-based care, the kind of healing arts, that prevent procedures from being necessary.

David Harlow:  Right, and as you say, we really need to reform that at a more global level --

Paul Grundy:  Yeah, that’s going to take a national effort and that’s going to take a real emphasis on priorities but other countries have done it, and in having done that they are very successful.  I mean the VA has done it, right?

David Harlow:  Yes, yeah that’s really transformed the VA --.

Paul Grundy:  I mean they are continuing to look at improving it as we speak but I mean the amount of progress they’ve made is phenomenal.

David Harlow:  Yes, so you mentioned the White House roundtable.  I wanted to ask about that did you find that to be a productive encounter?  Did you feel that folks were listening? And in your current visit, do you feel that there is an opportunity to make an impact?

Paul Grundy:  Absolutely.  I think there is a great deal of interest -- the video’s out there on C-Span or you can YouTube White House roundtable and find it -- but what they really did was present seven or eight of these early pilots and some of the results and then had a conversation around it and I think that the White House came away with the realization that there was a whole lot more happening on the ground than they even were aware of -- and they were aware of a lot – and, by the way, on the political spectrum there is interest in this, this whole transformation which is different than reformation on both sides of the aisle, I mean Grassley has been very supportive of it in recent meetings that we have with him in Iowa, Hatch in Utah has been extremely supportive of it.

There are medical home pilots that are going on at the Medicaid level in just about every state and so regardless of whether they are red or blue states this whole drive for transformation is really got a lot of steam.

David Harlow:  So what’s your prognosis, Paul?  Do you think that in five years from now, do you think this will be more fully diffused through the country?  Do you think we need national legislation in order to implement this --

Paul Grundy:  Well I think we first of all we are getting national legislation, because there is language in both the Senate and House around this.  I think certainly the White House sees the importance of more robust primary care and prevention, which is really what we are talking about, with the technology underneath to drive it, and I think in five years we will have a much clearer picture of the value of this in non-integrated systems.  I think in five years we will have a very clear picture of it in integrated systems, where already we are getting to see the evidence of that, you know and I think we’ll be in a place perhaps of some desperation -- given the Massachusetts experience of reformation without transformation -- i.e., more folks that need primary care without access to it, because the infrastructure is not in place to deliver it effectively.

David Harlow:  Well, thank you very much, Paul. I wonder, before we wrap up, if there is anything else that you like to share with us today about the state of the art, or your vision for the future of the patient-centered medical home.

Paul Grundy:  I think you covered it very well.  I have a sense of real optimism.  I am a glass- half-full kind of guy and I have a sense of real optimism that we are really beginning to see some transformation at the ground level and that physicians and the patients in practices where this has happened are happier patients, happier physicians and more effective care turns out to be actually cheaper care or more valuable care.

David Harlow:  Right -- and hopefully nobody can argue with that.  Well you've heard it here, folks:  Dr. Paul Grundy, glass-half-full kind of guy, speaking with us today. He is the President of the Patient-Centered Primary Care Collaborative and Director of Healthcare for IBM Global Wellbeing and Health Benefits.  Paul, I appreciate you taking the time to speak with us today, thank you very much.

Paul Grundy:  Thank you very much, it's only a pleasure.

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.

David Harlow twitterviewed by Lance Godard of 22 Tweets

I had my second twitterview experience yesterday, reproduced below courtesy of Lance Godard.  (You can read the first in Spanish at Diario Medico -- English translation available too.)  Please check out Lance Godard's growing archive of twitterviews with lawyers who tweet at 22 Tweets, or follow them live at #22twts.  For those unfamiliar with twitter, the bad spelling and butchered syntax in the interview below are a by-product of the 140-character-per-tweet limit.  For more health care law and policy and butchered syntax, follow @healthblawg on twitter.

Today we’re tweeting with health care lawyer, consultant and cancer survivor @Healthblawg

1. @Healthblawg, thank you for joining us today on Twitter. Tell us: who is @Healthblawg?
   I’m David Harlow, Boston-based health care lawyer, consultant, blogger, tweep & escaped New Yorker
   -

2. Tell us about your law practice.
   As a lawyer, I help #healthcare clients navigate the maze of business & regulatory issues unique to the industry…
   this includes structuring relationships and running interference w regulators …
   as a #healthcare consultant, I help clients define goals and develop structures and systems to achieve them…
   I also work with folks implementing #healthcare #socialmedia strategies See http://bit.ly/uxjg1 and http://bit.ly/4cLNub
   -
3. Wow - sounds like you’re the guy to know! What type of clients do you represent?
   #healthcare providers, vendors and payors - ranging from small MD practices to imaging centers to academic medical centers
   -
4. What is the single most important legal issue affecting those clients?
   Reimbursement & regulation drive the business of healthcare; we tie ourselves in knots trying to maximize $ & compliance …
   These days, everything is done with one eye on the (unknowable) future shape of federal #healthreform
   -
5. What do you tell every new client before you start working for them?
   I put my publc & privt sector exper, & my virtual netwrk (vs my fmr downtwn firm) to work for you, effectively & efficiently
   -
6. Tell us about one of the more significant client representations you’ve had.
   Diag imaging and cancer trmt provider dealing w st CON laws and fed antikickback & self-referral laws thru many transactions ...
   Had a healthy dose of business and regulatory issues in every bite
   -
7. Sounds very complex; hope it turned out well. Why do your clients hire you?
   Not my boyish good looks … Expertise, experience, efficiency, effectiveness
   -
8. What’s the most active area of your practice right now? Is that typical?
   Diagnostic imaging & anything touched by HIPAA and what I call Son of HIPAA (from ARRA) from perspec of providers & others ...
   There’s always some new reg du jour that generates a lot of heat
   -
9. Makes sense. You touched on this earlier, but what do the proposed Health Care reforms mean to your clients?
   Saving $ for society means taking it away from healthcare providers They must learn to be more efficient and effective …
   Innovations like patient-centered medical home http://bit.ly/HUHaj and value-based purchasing http://bit.ly/urdru are key
   -
10. Clearly there are significant changes to come. Has the econ crisis affected your clients’ ability to do business today?
    Sure: access to capital issues delay construction projects, uninsured folks defer elective care
    -
11. How do you market your practice?
    On line and in person: blog, tweets, LinkedIn, Fcbk (cf http://bit.ly/smlaw); also good old fashioned speaking, schmoozing
    -
12. Tell us about your blog, Health Blawg (http://bit.ly/ixjIo). Who do you write it for? Why should they read it?
    It’s for folks in the healthcare thick of things; I try not to repeat news but to analyze developments, put them in context


13. Why did you decide to become active on Twitter? Are you achieving those objectives?
    1. Connect w folks w related professional interests & see what develops 2. Channel for blog - Seems to work for me
    -
14. What specific impact on referrals and/or client engagements have you realized from your Web 2.0 activities?
    Broader reach locally and nationally; clients, referral sources & collaborators find me &/or validate their choice online…
    for example, my 3 newest clients & my current biggest client all found me via web 2.0 activities
    -
15. That’s great! How much time do you spend each day developing / enhancing your brand?
    Probably averages out to 1/2 to 1 hour a day or so, through blogging, tweeting, speaking, press interviews, etc.
    -
16. Let’s switch gears. What is the most significant issue currently facing the legal profession?
    Top issue for profession: Communicating value of services to clients; alt billing and implosion of BigLaw are symptoms
    -
17. What will the legal landscape look like in 10 years?
    More fragmentd & more consoldated, w commodity work & bet-the-farm work split up even more than today; decline of BigLaw…
    Big oppty for small firms to move in to the great middle
    -
18. What would you do if you weren’t a lawyer?
    Things I almost did: get a PhD in history & literature; become a professional photographer or photography curator
    -
19. How do you want to be remembered?
    Smart, funny guy w perfect work-life balance, & legal & healthcare chops
    -
20. What do you do when you’re not working?
    Family: off-grid last wk camping. Biking, incl the PMC http://bit.ly/PMC2009. Photography http://bit.ly/12CmbJ Love jazz too
    -
21. Congrats on raising $4667! What advice do you have for lawyers currently under-/ unemployed due to the economic crisis?
    Thanks … Be flexible. Go out on a limb. Do something you love in your free time. Network, network, network.
    -
22. And our last question for you: What advice do you have for people going to law school today?
    Your future clients are businesses & running a law practice is a business; you need to understand business, not just the law

That’s great advice. Thank you very much for answering our questions today

Thanks Lance - My pleasure

David Harlow
The Harlow Group LLC
Health Care Law and Consulting