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24 posts categorized "Medical Ethics"

December 03, 2012

Gimme My Damn Data - The ICD Edition

The latest news story to examine the issue of patient access to implantable cardiac defibrillator data (a variation on the theme of “gimme my damn data”) is an in-depth, Page One Wall Street Journal story featuring Society for Participatory Medicine members Amanda Hubbard and Hugo Campos. They have garnered attention in the past – one example is another piece on Hugo on the NPR Shots blog about six months back. The question posed by these individuals is simple — May I have access to the data collected and/or generated by the medical device implanted in my body? — but the responses to the question have been anything but. It is important to note that not every patient in Amanda’s or Hugo’s shoes would want the data in as detailed a format as they are seeking to obtain, and we should not impose the values of a data-hungry Quantified Self devotee on every similarly-situated patient. Different strokes for different folks.

The point is that if a patient wants access to this data he or she should be able to get it. What can a patient do with this data? For one thing: correlate activities with effects (one example given by Hugo is his correlation of having a drink of scotch with the onset of an arrhythmia — correlated through manual recordkeeping — which led him to give up scotch) and thereby have the ability to manage one’s condition more proactively.

We can get copies of our medical records from health care professionals and facilities within 30 days under HIPAA — and within a just a few days if our providers are meaningful users of certified electronic health records (it ought to be quicker than that … some day). In some states now, and in all states sometime soon (we hope), we can get copies of our lab results as soon as they are available to our clinicians.

Data from implantable medical devices is not covered by HIPAA until it is sent to the patient’s physician (on a periodic basis and usually in edited form — other data is typically retained by the device manufacturer) and entered into the patient’s medical record. It is, rather, governed by FDA rules, and the recent attention to this issue has prompted an FDA spokesperson to say that it would review a plan to give data directly to patients, but that data should be directed to physicians who can interpret it for patients. This is where the action will be in the future: the FDA could develop a framework to allow sharing of this data directly with patients. (The data is collected wirelessly in patients’ homes from the implantable devices.)

Not surprisingly, earlier this year, a Medtronic exec referred to the data in question here as “the currency of the future.” There is clearly a market for the secondary use of patient data — on a de-identified, or anonymized basis — for a variety of purposes, and this is the “big data” we are all hearing about so much lately. (The HIPAA enforcers at HHS recently released guidance on the de-identification of patient data for secondary use — i.e., use for research purposes.) There is value to be extracted from big data, and the question is: Who owns the value? Who owns the data? Suffering as I do from the professional disability of being a lawyer, I am reminded of Moore v. Regents of the University of California, the 1990 California Supreme Court case that found that Mr. Moore, a cancer patient who sought to share in the profits for the commercial cell line developed from cancer cells in a tumor removed from his body, had no property rights in his discarded body parts. Moore could perhaps be read to support the device manufacturers’ perspective that there is no value in the data coming from the implantable device until it is processed by the manufacturer.

Another perspective would be that each patient has a property right in the data generated by his or her body or implants. There have been a couple of discussions on e-patients.net and elsewhere about the notion of a “green button” or a “rainbow button” that would serve as a mechanism for patients to decide how to share their own data (in those cases, the discussion was focused on EHR data, but the principles ought to be the same here). If I want to share my EHR or device data with all, so that it may be aggregated with other patient data and used in research and the development of evidence-based medicine protocols, then I should be able to do so.  If I want to donate that data gratis, or if I want to see a small license payment collected by an intermediary (a la the Copyright Clearance Center), if I want to permit it to be used with full identifiers, or as a de-identified record, I should be able to do that.

The quest of patients with implanted devices to gain rights to data should not have to be so quixotic. The information in question is subject to a different regulatory scheme than EHR data, but that is an accident of history, technology and politics.  There is no fundamental distinction between a series of MRI images, or a blood test result, and a set of data downloaded from an implantable medical device.

It is possible that we have turned a corner on this issue. It is far from resolved, but the FDA is addressing it — or at least acknowledging it — publicly.

How close are we to resolving this issue? What obstacles do you see ahead? What other sorts of data have remained inaccessible to patients? Where is the next battlefield?

This post first appeared on e-patients.net, the blog of the Society for Participatory Medicine. I chair the Society's public policy committee.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

November 21, 2012

Engage With Grace

As patients, as family members, as friends, as health care providers, we have all faced end-of-life issues at one time or another, and we will face them again. And again. 

Having been through this process twice in the past year, I can only repeat that it is important to have The Talk, to help ensure that your family members' and friends' wishes about end-of-life care are clear, are documented and, as a result, are followed. If it helps to get the conversation going, use the Five Questions in the slide at the end of this post. 

Download your copies of the Massachusetts health care proxy form or other states' proxy or living will forms -- and add specific instructions about nutrition, hydration, and anything else that is important to you so that everything is crystal clear.  Having the conversation is a starting point; we all need to follow through and make sure that our loved ones' wishes are documented, placed in medical records, discussed with physicians and other caregivers, and honored.

And with that I turn it over to @engagewithgrace for #blogrally12 (the latest edition from a group of us kickstarted by Alexandra Drane, Matthew Holt and Paul Levy.) If you blog, consider copying the rest of this post, and putting it up now through the end of Thanksgiving weekend. 

- O -

One of our favorite things we ever heard Steve Jobs say is… ‘If you live each day as if it was your last, someday you'll most certainly be right.’

We love it for three reasons:

1) It reminds all of us that living with intention is one of the most important things we can do.
2) It reminds all of us that one day will be our last.
3) It’s a great example of how Steve Jobs just made most things (even things about death – even things he was quoting) sound better.

Most of us do pretty well with the living with intention part – but the dying thing? Not so much.

And maybe that doesn’t bother us so much as individuals because heck, we’re not going to die anyway!! That’s one of those things that happens to other people….

Then one day it does – happen to someone else. But it’s someone that we love. And everything about our perspective on end of life changes.

If you haven’t personally had the experience of seeing or helping a loved one navigate the incredible complexities of terminal illness, then just ask someone who has. Chances are nearly 3 out of 4 of those stories will be bad ones – involving actions and decisions that were at odds with that person’s values. And the worst part about it? Most of this mess is unintentional – no one is deliberately trying to make anyone else suffer – it’s just that few of us are taking the time to figure out our own preferences for what we’d like when our time is near, making sure those preferences are known, and appointing someone to advocate on our behalf.

Goodness, you might be wondering, just what are we getting at and why are we keeping you from stretching out on the couch preparing your belly for onslaught?

Thanksgiving is a time for gathering, for communing, and for thinking hard together with friends and family about the things that matter. Here’s the crazy thing - in the wake of one of the most intense political seasons in recent history, one of the safest topics to debate around the table this year might just be that one last taboo: end of life planning. And you know what? It’s also one of the most important.

Here’s one debate nobody wants to have – deciding on behalf of a loved one how to handle tough decisions at the end of their life. And there is no greater gift you can give your loved ones than saving them from that agony. So let’s take that off the table right now, this weekend. Know what you want at the end of your life; know the preferences of your loved ones. Print out this one slide with just these five questions on it.

Have the conversation with your family. Now. Not a year from now, not when you or a loved one are diagnosed with something, not at the bedside of a mother or a father or a sibling or a life-long partner…but NOW. Have it this Thanksgiving when you are gathered together as a family, with your loved ones. Why? Because now is when it matters. This is the conversation to have when you don’t need to have it. And, believe it or not, when it’s a hypothetical conversation – you might even find it fascinating. We find sharing almost everything else about ourselves fascinating – why not this, too? And then, one day, when the real stuff happens? You’ll be ready.

Doing end of life better is important for all of us. And the good news is that for all the squeamishness we think people have around this issue, the tide is changing, and more and more people are realizing that as a country dedicated to living with great intention – we need to apply that same sense of purpose and honor to how we die.

One day, Rosa Parks refused to move her seat on a bus in Montgomery County, Alabama. Others had before. Why was this day different? Because her story tapped into a million other stories that together sparked a revolution that changed the course of history.

Each of us has a story – it has a beginning, a middle, and an end. We work so hard to design a beautiful life – spend the time to design a beautiful end, too. Know the answers to just these five questions for yourself, and for your loved ones. Commit to advocating for each other. Then pass it on. Let’s start a revolution.

Engage with Grace.

Engage With Grace

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

January 04, 2012

Me too! It's not fair! The tragedy of the commons in the health care marketplace

There are at least two conversations going on in the health care marketplace today, each focused on one of two key questions. One is: How can we achieve the Triple Aim? The other is: Why do they get to do that?  (It's not fair! I want more!)  

Until we stop asking the second question, we can't answer the first question. Why? Because all too often the answer to the second question is the equivalent of: It's OK, Timmy, I'll buy you TWO lollipops; pick whichever ones you want.  

It's the tragedy of the commons, transposed to the health care marketplace.

Recent cases in point:

  • Avastin
  • Tufts Medical Center - Blue Cross Blue Shield of Massachusetts grudge match
  • Mammography and PSA guidelines

1.    Avastin.  Late last year, the FDA yanked its breast cancer treatment approval for Avastin, based on a finding that it does not meet the "safe and effective" standard. CMS says it will still pay for the drug anyway, as will many commercial payors, based on physician judgment.

2.    Tufts Medical Center - Blue Cross Blue Shield of Massachusetts. The contract negotiation (out in public view) focused, in part, on Tufts' complaint that BCBSMA pays way more for health care services provided by another network, Partners Health Care, and that it should be compensated on the same scale.  (Others have noticed this disparity too, and have found that higher payments were not accompanied by higher quality -- see reports by Massachusetts state agencies.)  In the context of the present discussion, we may wish to consider whether Partners should be paid less, rather than whether Tufts Medical Center should be paid more.  This episode, according to some, will pave the way for more regulations.

3.    Mammography and PSA guidelines.  Evidence-based medicine says fewer tests are needed, yet consumer demand based on anecdotal evidence, or unwillingness to shift gears becasue of expaectations based on prior recommendations, remains in place, and some payors elect to continue to pay for testing in siutuations that the evidence says testing is not warranted. 

(These are just a few examples "ripped from the headlines" to make a point -- please don't attack my conclusions if you disagree with the specifics of these examples offered, and I invite you to offer additional examples.)

The health care marketplace is, not to put too fine a point on it, imperfect. Often, patients demand goods or services based on direct-to-consumer advertising or peer recommendations without an evicence-based clinical need, physicians are happy to order the drug or the test because they have little or no economic incentive to refuse (and perceive an economic incentive to comply -- avoidance of a potential malpractice case over a missed diagnosis, for example), and patients have little or no exposure to the actual cost of the drug or test at issue.  Things are changing, to be sure: the patient co-pay for the demanded drug may be a little higher or the patient may have a high-deductible health plan, the physician may have a slight disincentive to ordering the more expensive drug or test, but thus far these economic incentives have not been significant enough to shift behavior in a significant manner, and the commons -- the money available for all public and private sector spending, on everything -- has been laid waste: diverted, a few dollars at a time, into the gaping maw of the health care beast.  The result is not improved health status -- just increased health care spending, and decreased spending on everything else.  

Unfettered patient choice coupled with payor-provider risk sharing seems to some to be a recipe for disaster (see: myriad predictions of ACO-induced doom and gloom). CMS is staking out a claim in this new territory, and the folks at the Center for Innovation are being quite frank about it: We have a big chunk of change at our disposal right now to help change the health care marketplace, but in the future we will all have to do more with less.  

At least one national physician group has finally come around to this way of thinking: Per NPR, The American College of Physicians greeted the new year by issuing the latest edition of its ethics manual, which includes the following passage:

In making recommendations to patients, designing practice guidelines and formularies, and making decisions on medical benefits review boards, physicians' considered judgments should reflect the best available evidence in the biomedical literature, including data on the cost-effectiveness of different clinical approaches.

ACP President Virginia Hood told NPR:

We also have to realize that if we don't think about how resources are used in an overall sense then there won't be enough health care dollars for our individual patients. So while concentrating on our individual patients and what they need we also to think on this bigger level both for their benefit and for the well-being of the community at large.

It seems to me that there is a way forward, but it will have to involve a delicate mix of market and regulatory models.  Adding ethics into the mix may be the way to pull us out of the purely economic tragedy of the commons.  

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

November 24, 2010

Engage With Grace

As patients, as family members, as friends, as health care providers, we have all faced end-of-life issues at one time or another, and we will face them again.  And again. 

This weekend, the "Engage With Grace" message is being broadcast virally, through a "blog rally," at a time when many people are with family and friends over the long weekend.  The point is: we all need to have the potentially uncomfortable conversation with people close to us about what kind of treatment we would want, and they would want, if incapable of making or communicating health care decisions.  CNN ran a story on Engage With Grace yesterday.

End-of-life decision-making has long been an issue of great personal and professional interest to me, and I am proud to have played a role in having out-of-hospital DNR orders recognized in Massachusetts by EMS providers, as an example. 

Download your copies of the Massachusetts health care proxy form or other states' proxy or living will forms -- and add specific instructions about nutrition, hydration, and anything else that is important to you so that everything is crystal clear.  My mom kept a stack of living will forms in the dining room when I was growing up, and was not shy about raising the issue with dinner guests and offering to witness their directives.  Having the conversation is a starting point; we all need to follow through and make sure that our loved ones' wishes are documented, placed in medical records, discussed with physicians and other caregivers, and honored. 

When I have the opportunity to speak to groups of lawyers or health care providers, I often ask for a show of hands: how many of you have health care proxies?  The percentage seems to have increased over time, but it is still not where it needs to be.  If groups that should be above average in this respect are not all raising their hands, then we clearly have a lot to do in terms of educating the general public about the need to have the sometimes difficult conversation with friends and family members.  That's what the Engage With Grace project is all about.  And with that, I turn over this post to Engage With Grace:

*    *    * 

Things we are grateful for this year

For three years running now, many of us bloggers have participated in what we’ve called a “blog rally” to promote Engage With Grace – a movement aimed at making sure all of us understand, communicate, and have honored our end-of-life wishes.

The rally is timed to coincide with a weekend when most of us are with the very people with whom we should be having these unbelievably important conversations – our closest friends and family.

At the heart of Engage With Grace are five questions designed to get the conversation about end-of-life started. We’ve included them at the end of this post. They’re not easy questions, but they are important -- and believe it or not, most people find they actually enjoy discussing their answers with loved ones. The key is having the conversation before it’s too late.

This past year has done so much to support our mission to get more and more people talking about their end-of-life wishes. We’ve heard stories with happy endings … and stories with endings that could’ve (and should’ve) been better. We’ve stared down political opposition. We’ve supported each other’s efforts. And we’ve helped make this a topic of national importance.

So in the spirit of the upcoming Thanksgiving weekend, we’d like to highlight some things for which we’re grateful.

Thank you to Atul Gawande for writing such a fiercely intelligent and compelling piece on “letting go”– it is a work of art, and a must read.

Thank you to whomever perpetuated the myth of “death panels” for putting a fine point on all the things we don’t stand for, and in the process, shining a light on the right we all have to live our lives with intent – right through to the end.

Thank you to TEDMED for letting us share our story and our vision.

And of course, thank you to everyone who has taken this topic so seriously, and to all who have done so much to spread the word, including sharing The One Slide.

theoneslide

We share our thanks with you, and we ask that you share this slide with your family, friends, and followers. Know the answers for yourself, know the answers for your loved ones, and appoint an advocate who can make sure those wishes get honored – it’s something we think you’ll be thankful for when it matters most.

Here’s to a holiday filled with joy – and as we engage in conversation with the ones we love, we engage with grace.

To learn more please go to www.engagewithgrace.org. This post was written by Alexandra Drane and the Engage With Grace team.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

 

 

March 13, 2009

Massachusetts Code of Conduct finalized for Pharma, device manufacturers, health care providers

The code of conduct adopted in Massachusetts is the most restrictive set of rules in the nation, crows the Department of Public Health, and mutters the industry.  The final MA pharma and medical device conflict of interest rule is posted on the DPH website, together with related comments, memos and presentations.  In brief, the rule "sets out what is and is not permissible for pharmaceutical and medical device manufacturers with respect to providing meals, sponsoring continuing medical education and other conferences, and otherwise providing payments or other items of economic benefit to Massachusetts health care practitioners."

Some fear the new regulations will lead to a drop in medical conferences held in Massachusetts, further battering the local economy.

Some wonder whether they would have helped nip in the bud past medical research fraud (probably not).

So what do they do?  They implement part of the Massachusetts health reform law, part 2, so much of the commentary ought to have been (and was) directed at the legislature a while back, before it took action, and not at DPH, which is essentially just implementing the legislation.  The rules build on PhRMA and AdvaMed codes of conduct, but do go a wee bit further.  In DPH legalese:

Chapter 111N and 105 CMR 970.000 regulate pharmaceutical and medical device manufacturer conduct in three ways, requiring pharmaceutical and medical device manufacturers to:  (1) adopt and comply with a state-authored code of conduct, (2) provide compliance information to the Department, and (3) disclose sales and marketing related payments to covered recipients. Sections 970.006-970.008 of the Department’s proposed regulations set out what is and is not permissible for pharmaceutical and medical device manufacturers with respect to providing meals, sponsoring continuing medical education and other conferences, and otherwise providing payments or other items of economic benefit to Massachusetts health care practitioners.  Additionally, the Department’s proposed regulation outlines the statutory compliance directives in Section 970.005 and interprets the contours of the disclosure requirements for pharmaceutical and medical device manufacturers in Section 970.009.  Finally, the Department’s proposed regulation reiterates the penalties outlined in Chapter 111N and provides procedures for enforcing the code of conduct, compliance and disclosure requirements of 105 CMR 970.000.  The Department’s proposed regulations seek to address potential undue influence in interactions between pharmaceutical or medical device manufacturing companies and health care practitioners, and increase transparency with respect to such relationships without compromising Massachusetts health care consumers’ access to clinical trials and new discoveries and treatments arising from legitimate and beneficial industry interactions with health care practitioners.

See the final reg hotlink above for the full memo, FAQs, the full text of the regs, a presentation outlining the regs and comparing them with other states' regs, etc.

There's a lot to digest here.  Bottom line: Massachusetts may be in the vanguard on this front, but the industry and the rest of the nation will be following right along, as the pendulum swings to the pro-regulatory mindset.  There is less and less stomach in Washington and on Main Street for anything that even smells of financial impropriety, and the national imperative to get health care costs in check will likely fuel further action on this front. 

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

November 26, 2008

Engage With Grace

As patients, as family members, as friends, as health care providers, we have all faced end-of-life issues at one time or another, and we will face them again.  And again. 

This weekend, the "Engage With Grace" message is being broadcast virally, through a "blog rally," at a time when many people are with family and friends over the long weekend.  (Thanks to Paul Levy and Charlie Baker for getting the issue out of the blogosphere and onto page one of the Boston Globe today, too.)  The point is: we all need to have the potentially uncomfortable conversation with people close to us about what kind of treatment we would want, and they would want, if incapable of making or communicating health care decisions.  (If you really want to monopolize Thanksgiving dinner conversation, you could also start the family health history conversation being promoted by the Surgeon General.)

End-of-life decisionmaking has long been an issue of great personal and professional interest to me, and I am proud to have played a role in having out-of-hospital DNR orders recognized in Massachusetts by EMS providers, as an example. 

Download your copies of the Massachusetts health care proxy form or other states' proxy or living will forms -- and add specific instructions about nutrition, hydration, and anything else that is important to you so that everything is crystal clear.  My mom kept a stack of living will forms in the dining room when I was growing up, and was not shy about raising the issue with dinner guests and offering to witness their directives.  Having the conversation is a starting point; we all need to follow through and make sure that our loved ones' wishes are documented, placed in medical records, discussed with physicians and other caregivers, and honored. 

When I have the opportunity to speak to groups of lawyers or health care providers, I often ask for a show of hands: how many of you have health care proxies?  The percentage seems to have increased over time, but it is still not where it needs to be.  If groups that should be above average in this respect are not all raising their hands, then we clearly have a lot to do in terms of educating the general public about the need to have the sometimes difficult conversation with friends and family members.  That's what the Engage With Grace project is all about.  And with that, I turn over this post to Engage With Grace:

*    *    * 

We make choices throughout our lives - where we want to live, what types of activities will fill our days, with whom we spend our time. These choices are often a balance between our desires and our means, but at the end of the day, they are decisions made with intent. But when it comes to how we want to be treated at the end our lives, often we don't express our intent or tell our loved ones about it.

This has real consequences. 73% of Americans would prefer to die at home, but up to 50% die in hospital. More than 80% of Californians say their loved ones "know exactly" or have a "good idea" of what their wishes would be if they were in a persistent coma, but only 50% say they've talked to them about their preferences.  But our end of life experiences are about a lot more than statistics. They're about all of us.

So the first thing we need to do is start talking. Engage With Grace: The One Slide Project was designed with one simple goal: to help get the conversation about end of life experience started. The idea is simple: Create a tool to help get people talking. One Slide, with just five questions on it. Five questions designed to help get us talking with each other, with our loved ones, about our preferences.

And we're asking people to share this One Slide - wherever and whenever they can.at a presentation, at dinner, at their book club. Just One Slide, just five questions. Lets start a global discussion that, until now, most of us haven't had.Here is what we are asking you: Download The One Slide and share it at any opportunity - with colleagues, family, friends. Think of the slide as currency and donate just two minutes whenever you can. Commit to being able to answer these five questions about end of life experience for yourself, and for your loved ones. Then commit to helping others do the same. Get this conversation started.

Let's start a viral movement driven by the change we as individuals can effect...and the incredibly positive impact we could have collectively. Help ensure that all of us - and the people we care for - can end our lives in the same purposeful way we live them. Just One Slide, just one goal. Think of the enormous difference we can make together.

(To learn more please go to www.engagewithgrace.org. This post was written by Alexandra Drane and the Engage With Grace team)

*    *    *

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

November 02, 2008

Don Berwick, CEO of the Institute for Healthcare Improvement, speaks with David Harlow about the 5 Million Lives Campaign and more

Don Berwick, CEO of the Institute for Healthcare Improvement, spoke with HealthBlawg last week, as IHI comes close to wrapping up its 5 Million Lives Campaign.

The audio file of my interview with Don Berwick (about 20 minutes long) is available for download/podcast. A full transcript is at the end of this post (and in the linked transcript.

IHI sponsors an impressive array of collaborative health care improvement programs, offering programmatic support and creating a network of like-minded institutions and leaders who provide feedback to each other on improvements to their local systems.  The 5 Million Lives Campaign is the latest in a long line of successful campaigns.

I asked Berwick about the plethora of health care indicators used in P4P and pay-for-reporting plans, and he suggested that the 1,000 measures in use today could be whittled down to far fewer, that the "cacophony" could be eliminated, with better results for patients.  The 5 Million Lives Campaign, for example, is built on twelve "planks," ranging from reduction in infections and med errors to board engagement -- the latter, a critical measure not often cited in connection with patient care process and outcome measurement.  He also noted that NQF will be making an announcement in the near future identifying six key predictive measures.

IHI uses these indicators to "pull" health care providers into improved quality, according to Berwick; payors use them to "push" providers along.

Berwick estimates that 30% of costs in the U.S. health care system are "pure waste" -- excess administrative costs and medical expenses, where variation is based on habit, not evidence.  The current economic climate brings greater urgency to the need to bring these costs under control.  

While cautioning that information technology "isn't magic," Berwick emphasized that he has been calling for widespread implementation of EHRs for 30 years, so long as the EHR roll-out doesn't simply transfer paper processes to the computer but, rather, serves as an opportunity to redesign patient care and administrative processes.

Another opportunity for improvement lies in improving coordination of care across traditional boundaries -- e.g., primary care to acute care to chronic care.  Berwick used the "M" word to describe the mechanism most likely to help in this arena: managed care: "not the evil managed care, not the mutant managed care, but the good managed care," that could really help patients, e.g., through a chronic illness.

In discussing future policy directions post-election, Berwick stressed that the U.S.needs to join the rest of the industrialized world and recognize health care as a right.  It seems clear that if that were to happen, many other changes in the health care system would need to be made as well -- finance, delivery system, health care provider training and supply -- all topics worth further examination another day.   

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


Interview of Donald Berwick, CEO of the Institute for Healthcare Improvement
October 28, 2008

David Harlow:  This is David Harlow of HealthBlawg, and I have with me today Don Berwick, CEO of the Institute for Healthcare Improvement.  Good morning, Dr. Berwick.

Don Berwick:  Good morning.

David Harlow:  Thank you for joining us today.  I wonder, for starters -- though I’m sure many folks are familiar with your organization -- if you could give us a snapshot description of what your organization does and its mission.

Don Berwick:  Sure.  The Institute for Healthcare Improvement, IHI, is a non-profit organization started in 1991 by a group of colleagues around the United States.  Our mission is to help accelerate the improvement of healthcare system all over the world.  We have projects mostly in the US and Canada but also in Europe, the Pacific and South Africa now and several developing countries.  So our basic work is research and development first.  We try to identify or create prototypes that really perform current designs in healthcare for better safety and effectiveness and patient-centeredness and lower cost.  We then try to test those prototypes with colleague organizations around the country or around the world, hospitals or clinics or practices that are willing to try new designs and see if they work and debug them.  And then we have lots of activities to spread the innovations we can find that are helpful.  We do this through large meetings.  We have our big national conference coming up in December which will have about 6,000 people there and 15,000 on satellite.  We have a website.  It’s open to everyone, ihi.org.  And in the past four years, we sponsored major national campaigns, the 100,000 Lives Campaign and the 5 Million Lives Campaign, which are intended to get literally thousands of hospitals to adopt a focused set of changes that make patients safer and reduce unnecessary harm and mortality.

David Harlow:  Yes.  And I understand that through the 5 Million Lives Campaign that something on the order of 80% of US hospital beds are now in institutions that have signed on, if you will, to this campaign.

Don Berwick:  And the response has been amazing.  We proposed twelve changes in care processeses and governance in hospitals to make patients safer.  And I think the last number was 4,030 hospitals have signed up in the United States alone, and there’s spinoff campaigns being run by colleagues and friends in eight or nine other countries.  So the response has been pretty dramatic.  I’m sure but not all of the places are actually seriously changing process but many of them are, and we have been seeing phenomenal results in some.

David Harlow:  Well government payors, CMS, and private payors as well have been tracking particular care processes or care outcomes – I’d actually been interested to hear your perspective on that -- and have been using as the basis for pay-for-performance programs.  Now my understanding is that the programs that you’re describing are not necessarily tied to any payors but rather to care improvement in a more general sense.  Is that a fair statement?

Don Berwick:  Yeah.  IHI is one player in the changing landscape in healthcare that has both elements of push and elements of pull.  The pull is what IHI deals with; we’re working with hospitals and clinics and clinicians and leaders all over the world and appealing, I think, to their intentions to do well.  They want to be proud of their work and they’re interested in how to make changes and they’re being helped by transparency by turning the lights on and much better able to measure patients’ injuries or mortality or patient satisfaction for example to where we’ve ever been before.  So there’s a side here that reflects ambition, aspirations, kind of a spirit in the work force.  And I think that’s what IHI basically works with…but it’s no surprise.  There’s push also from the society at large, the payors like the government payors and private payors, the public at large represented through consumer groups, Consumers’ Union, AARP and so on, and the employers who are paying the bills upstream for their employees.  Those outsiders to healthcare want healthcare to be quite accountable.  And once it becomes evident that certain kinds of complications or extra cost or overuse or risks are reducible or in some cases can be eliminated, there’s no surprise that the environment, the payor community, the patients have wondered or are really asking and I guess, in some cases demanding that the changes be made.  There’s push and pull.

David Harlow:  I understand that yesterday IHI ran a national learning network event and I imagine a number of ideas along these lines were showcased.  I wonder if you could speak to a couple of them and maybe observations on where some of the successes are and what you see as some current trends.

Don Berwick:  Sure.  The National Network Day which was yesterday is one of the big national events we’ve been running in the campaign period of now four years of campaigning.  I should say first that the campaign that IHI is supported by philanthropy so that, for example the Blue Cross Blue Shield Association and Blue Cross Blue Shield plans around the United States have donated considerable amounts to IHI and to local entities that help spread changes.  Cardinal Health has helped.  Other foundations have helped.  So everything in the campaign is free.  There’s no cost to hospitals that want to get access to it.  So the campaign team has been funding different vehicles to give access to anyone that wants information on how to make changes and especially reports from places that have done so.

So yesterday was a day of sharing in which after some introductory remarks by among others, Richard Umbdenstock, the president of the American Hospital Association.  We ran, all day long, virtual workshops on the phone and internet and web in which hospitals can report in on things they are proud of doing or lessons they’ve been learning.  We had hospitals that have gone a year or two or in one case four years without a single ventilator pneumonia.  We have the central line bundle which causes reduction of bacteremia in patients with central lines -- they don’t get septic -- which we developed a number of years ago.  It has been expanded in the keystone project in Michigan.  And they did a workshop on prevention of bacteremia.  We have hospitals that are just making tremendous gains even in some cases hospitals that have reduced mortality rates measurably, dramatically in some cases.  So they’re sharing how they did it and then curious teams and hospital leaders who wanted to understand how others have done it can get that information.  We have about 200 mentor hospitals in the campaign.  These are the hospitals that we track major results reduction or pressure sores or improvement of heart attack care or reduction of infection and they sort of donate their knowledge back into the pool of knowledge.  And they also were available on this National Network Day.

We had through the day, I’m told, over 2,400 phone lines were open at one point or another to get these information.  At the peak we had something like 460 or 470 phone lines open with ten or twenty people at each phone line.  That’s thousands of people getting information from each other.

David Harlow:  That’s terrific.  And it’s very encouraging just to see the level of engagement in this sort of activity.  You mentioned earlier twelve changes in care processes that were to be undertaken and I’m wondering how you would compare these processes or how these processes are selected because I’m comparing that to the many -- in some cases, dozens and dozens of processes or indicators that are collected and reported on to various payors including government payors.  I guess the question is as hospitals are involved in dealing of a number of different payors and required to report on many different indicators, has your work shown that there is a small pool of  indicators that would really work as proxies for all these others in terms of institutional level of quality of care.

Don Berwick:  Well, David, first you’re absolutely right about the cacophony of indicators and measures.  Hospitals today have, I think, quite literally over 1,000 variables they have to report on somewhere about their own performance.  It really makes them crazy and it doesn’t allow for the kind of focus that we really need nationally.  And we don’t yet have a national agenda of prioritized improvements, what are the most important ones to make.  I think soon some will emerge with the National Quality Forum which is this public-private partnership group that’s going to articulate some goals.

In fact there is a press conference November 17th by NQF that’s going to lay out six goals for American care which I’m pretty excited about.  But the IHI’s campaign planks, we call them, the twelve planks, were picked because we had great evidence from the scientific literature, our own prior work, or the work of others, that these changes could be made by hospitals that they would result in reductions in harm and in some cases mortality and were not expensive to do.  So they’re a selected group.  They do overlap quite consciously with a lot of the indicators you’re referring to.  We have a matrix -- you can see it on our website -- that shows how if you’re on board the twelve campaign planks at the moment you’re really hitting a lot of other requirements from the Joint Commission and CMS and payors and so on.  So there’s some crosswalk.  There are also logical ones.  There are ones where everyone knows we can really make progress. A number of them bear on infection:  like reduction of surgical site infections, reduction of central line infections, reduction of ventilator pneumonias, reduction of methicillin-resistant staph infections.  There’s one on pressure sores, an avoidable complication that we know can be reduced dramatically within hospitals.  We’re focused on cardiac care, which is an enormous area for hospital work: both acute heart attack care, making that very reliable, and the same for congestive heart failure which is the most common reason for admission in Medicare.

There are are a number focused on drug errors, medication reconciliation when patients move from one place to another that’s one.  And another is a specific focus on high-alert medication -- that’s insulin, sedatives, narcotics, and anticoagulants -- which explain over half the serious injuries that patients get from medication errors in hospitals.

The twelfth plank is unusual and that’s not about a condition, it’s about governance.  We call it Boards on Board and that reflects the need, really the imperative, that hospital governance and executive leaders take, in this case, patient safety firmly under their stewardship.  This improvement in safety that we can achieve is not achieved without leadership from the boardroom and the executive suite.  So plank twelve, Boards on Board, it coaches hospital boards on how to take cognizance and really be helpful to the improvement of patient safety.  It’s kind of a rational set.  It doesn’t do everything.  There are other areas that we will be getting into.  In fact IHI, after this December meeting, December National Forum, we’re going to be articulating a set of entirely expanded set of goals and aims that are even more related to what’s happening in the environment right now.

David Harlow:  Great!  Are those would tie in with some of the other standards or goals that are being articulated by NQF and others?

Don Berwick:  Yeah.  We’re going to try to make sense of the cacophony so it won’t be just repeating a bunch of, a long, long list of standards but trying to come up with this real serious leverage.  And by the way, incorporating cost reduction -- because among the improvements you can achieve with really conscientious process management is reduce cost while helping increase the experience, improve the experience of patients and the staff so you’re going to see a number of initiatives on our part that are strongly focus on wise reduction and cost because we badly need those as well.

In the end, that’s where we’re headed for our hospitals -- because this campaign is focus on hospitals right now -- hospitals that function at a completely new level of reliability and patient-centeredness and lower cost.  And that’s what we’re going to try to accumulate and plan for over the coming months.

David Harlow:  Do you have a view on expanding some of this work to non-hospital settings as much of healthcare is moving -- ?

Don Berwick:  Oh yes for sure.  IHI has perhaps, well now close to half our work in the non-hospital settings.  Next March, just as we have our National Forum in the December, we have, I think, our tenth annual meeting called On Improving Office Practices and that focuses on ambulatory care, care across the continuum.  We currently have a grant from the Commonwealth Fund to work at the level of states on reduction of unnecessary hospitalization through improvement of care for chronic illness across the continuum.  We have a wonderful project with the Indian Health Service now which is focused on chronic disease care in the Indian Health Service which is almost completely an outpatient issue, not an inpatient issue.  We also have a major research and demonstration project now underway called the Triple Aim project which deals with population-based care, dealing even beyond care into issues of prevention of illness and the total per capita cost of healthcare in a population.  As of now, we have over forty organizations, most in the US but not all, working on innovations and new designs to improve care at the population level.  So we’re doing a lot more than just hospital care, but a lot of hazards lie in hospitals and so we’re going to keep the spotlight there as well.

David Harlow:  Yes.  You’ve mentioned cost control and cost management.  Do you see a focus on that increasing in the minds of hospital administrators given the current economic crunch or is this a long-standing issue that’s just being worked on now?

Don Berwick:  Access cost has been a problem in the US healthcare for three decades at least so it’s a chronic problem of high severity.  We’re at a great disadvantage economically as a country because of what we pour in to healthcare -- close to 17% of the GDP.  And since IHI is a global organization we work with and see systems in Europe and elsewhere that function at half our cost per capita and get results every bit as good as ours and, if you read the Commonwealth Fund’s research, in most cases a lot better.

We’re at the bottom of some lists that you’d expect that we’d be on top of given our expenditures so it’s chronic.  I think the latest financial crisis only adds fuel to that fire and I think converts a chronic crisis into something pretty close to an economic emergency.  And I’m sure hospitals are making major adjustments now as all organizations have to in our country and worldwide.

From IHI’s point of view, this is about waste.  It’s not about cutting back on things people need.  It has to do with getting very smart about what it is that we do that doesn’t help anybody and getting that out of the system.  My own estimate through the years has been that at least 30% of American healthcare costs are in that pot.  They don’t help anyone.  They’re just pure waste.  They’re administrative cost and excess care that can’t help, unscientific care, variation based on habit, not fact.  And conscientious professional leadership, conscientious organizational stewardship, and good public policy ought to be able to identify that overuse, that waste, and remove it from the system thus saving a lot of money without harming a single patient and advancing the health of communities.

David Harlow:  Do you see some of the new information technology tools as being particularly useful or more helpful in trying to move organizations into an evidence-based medicine mind set?  You and others have been talking for years about certain lean management principles, but as you’ve said there’s still a tremendous amount of excess cost in the system.  Do you see an opportunity with expansion of information technology in this area?

Don Berwick:  Yeah.  I’m of two minds on information technology and on the one hand, it’s kind of falling off a log to say we need it.  I mean, for Pete’s sake, we’re still not even in 20th century, let alone 21st century information technology in most of healthcare and it’s time to go there.  Our care would be more reliable.  The flow would be smoother.  Patients would be remembered.  Chronic disease care would be integrated.  Finance could be better managed if we have better information.  And so we definitely need to modernize healthcare information technologies and the underlying infrastructures and rule base for that.  There’s no question that would be helpful.  It’s time to have an electronic medical record and I was part of the Institute of Medicine committee thirty years ago that said that.

On the other hand, I don’t think we should expect information technology to be magic.  It isn’t magic.  In fact, the big mistake would be that we could introduce information technology and not change processes and then we’d just be automating the current inefficiencies and defects and it would be easy to that.  We have to do two things which are modernize information and change care and the combination would be extraordinarily powerful.  Is it necessary to modernize information in order to change care?  I don’t know.  At some level, no.  I think it’s possible for a local unit or clinic or hospital to do quite a bit with whatever information they happen to have, but it certainly would be helpful that we can get synergy between information management and improvement.

In some organizations we’re seeing that.  There are recent breakthrough, for example Kaiser Permanente which has invested literally billions of dollars on modernizing its information platform but they are also beginning to harvest from that important new forms of redesign, such as making home the hub for care.  That’s one of their slogans and it really is real.  And they’re going to exploit opportunities for better care with better information and I think could give us a good head ups on what’s possible.  They are not alone and so we need to be tracking these very progressive redesign projects.

David Harlow:  Sounds great.  So in sort of wrapping up, I’m wondering if there’s any other areas or any other advice that you might offer to healthcare organizations as we face both the economic crisis and a new administration in Washington, and also what you might have to say to a new administration in Washington, areas of emphasis that you would like to see from a federal policy perspective.

Don Berwick:  Well, let me start with policy and then I’ll talk about organizations.  At the  policy level, in our country, the most important leadership we need governmentally to me is back in the domain of ethics and human rights.  I mean, healthcare is in almost every other country in the world -- and certainly in every other developed country -- clearly a human right.  And they don’t negotiate on that point.  They then figure out how to make it so and struggle through the difficulties of doing that.  We haven’t done that in this country and I’m looking for congressional, presidential leadership that finally crosses that bridge and says it’s just not right to be a wealthy, first world country, and have anyone be denied healthcare that they need.  A big important form of that and also related to policy is to close the gap between rich and poor and black and white in our country.  The worst [sic] predictor of your health status today in America is the color of your skin and we need to end that as a fact.  It has to be changed, and so I think that is also a matter of public commitment and federal policy and governmental leadership.

At the more technical level, we need government leadership to modernize information technology, that’s clear.  We also need to reconfigure the role of government, especially as payor, to help us integrate care across boundaries.  We’re very fragmented in the way we pay for care even from the federal government level and we need better chronic disease care, especially, in this country.  And that’s going to involve new forms of integrated payment that return us to if I dare say the best kind of managed care not the evil managed care, not the mutant managed care, but the good managed care, that really means I’m helped in my journey through my chronic illness.  I think we need to focus on wise cost reduction and we need federal policy that supports that.  And we need to research on that so we understand what costs can be reduced without harming people.  We need much more voice for patients.  CMS and others have been very good in helping patients speak up through proper data and surveys and reporting requirements.  And I think we need even more of that.

On the organizational side, I would guess the two most important lessons I’ve been learning are first, it does take leadership.  Until executives, heads of boards, the lay executives, clinical executives, nursing leaders, physician leaders, own improvement of care as their job, it’s very hard for the workforce to get organized to make care better and we really need executives alert and at the helm to make care better.  It’s got to become part of the job, and every way we can do that will help.  The other good side of that lesson is, I think, executives who do that are going to find a workforce -- doctors, nurses, pharmacists, receptionists, therapists, and middle managers -- they’re going to find a work force ready to really help.  I mean IHI’s 5 Million Lives Campaign is uncovering this enormous amount of goodwill on the workforce to make care better.  It’s there.  And executives and boards that realize it and go for it are going to find it available and I think that’s a piece of good news that I want them to hear.

David Harlow:  That is a piece of good news.  And I thank you for joining us today.  I’ve been speaking with Don Berwick.  This is David Harlow on HealthBlawg.  And Dr. Berwick, thank you again for joining us.  I appreciate it and enjoyed our time speaking together.

Don Berwick:  Thank you, David.  It’s been my pleasure.

March 13, 2008

Medblogging and privacy issues hit the mainstream media

. . . Well, at least NPR's Morning Edition.  Is that MSM?  This morning's piece on medblogging ethics included interviews with a couple of medbloggers, who blog at Kevin MD and Wachter's World.  (Kevin hit the MSM daily double today: see USA Today.)

Our paths sometimes cross at Grand Rounds, the weekly medblog carnival.

Check out past HealthBlawg posts on medblogging ethics in general and Flea in particular, as well as Eric Turkewitz's interview of Flea.   

-- David Harlow

February 03, 2008

Medical apologies radio show

There was a terrific edition of Radio Boston on medical apologies on WBUR, NPR's Boston affiliate, last week.  Have a listen and take a look at the additional on-line materials.  Take a look at a past HealthBlawg post on medical apologies too.

-- David Harlow

January 24, 2008

Flea revisited

Eric Turkewitz interviewed Flea last week at New York Personal Injury Law Blog.  Don't miss the comments, or the link to another interview with Flea as well.  See my further thoughts on the subject here.

Hat tip to Bob Coffield.

-- David Harlow