A plane crash every day

Every day that has passed as they search for the wreckage of the Malaysia Airline plane, another plane has crashed in America.  Well, better put, the equivalent number of people have died every day from preventable harm in America's hospitals.

Which story gets our attention?  Which is the greater public health hazard?

Remember Captain Sullenberger's words as he remarked on the scattered application of systemic approaches to safety in the health care industry: "We have islands of excellence in a sea of systemic failures. We need to teach all practitioners the science of safety."

"I wish we were less patient. We are choosing every day we go to work how many lives should be lost in this country."

Inspiring

I missed this story a couple of years ago about a boy from Sierra Leone, although it was just recently reposted.  If you haven't seen it, I think you'll be inspired when you watch the video.

Hypertension guidelines on WIHI

Madge Kaplan writes:

The next WIHI broadcast — How High? How Low? Shared Decision Making Amidst Shifting (Hypertension) Guidelines — will take place on Thursday, March 13, from 2 to 3 PM ET, and I hope you'll tune in. This is a special collaboration with the Journal of the American Medical Association that we're calling JAMA on WIHI: An Online Audio Forum on Quality.

Our guests will include:

• Craig W. Robbins, MD, MPH, Medical Director, Center for Clinical Information Services, Kaiser Permanente Care Management Institute
• Don Goldmann, MD, Chief Medical and Scientific Officer, Institute for Healthcare Improvement
• Peter Basch, MD, FACP, Medical Director, Ambulatory EHR and Health IT Policy, Medstar Health
• Eric Peterson, MD, MPH, Director, Duke Clinical Research Institute; Professor of Medicine, Division of Cardiology, Duke University Medical Center

Hypertension is a hot issue, especially in the US, where an expert committee recently recommended that the available evidence does not support initiating treatment (largely medication) for people 60 years or older until their blood pressure climbs to 150 over 90. The decades-long consensus had been to initiate treatment at 140 over 90, which is still the recommendation for adults younger than 60. The reasons for this change are possibly as complicated as the guideline process itself, but one of the chief concerns of the majority on the Eighth Joint National Committee (“JNC 8”) is the risk associated with aggressive treatment of hypertension in older adults.

So, can we talk about this? We certainly hope so, and we invite you to bring your real-world experience making sense of changing guidelines with your patients managing high blood pressure (and other conditions) to a special WIHI produced in collaboration with JAMA: March 13, 2014: How Low? How High? Shared Decision Making Amidst Shifting (Hypertension) Guidelines. 

Some experts take exception to the committee’s findings and the process itself. Our guests are going to take all that into consideration, but, with your help, we’ll focus primarily on the best ways to approach changing and often-debated guidelines when working with patients to achieve optimal health. (The new guidelines for determining who should be put on statins to lower cholesterol are another case in point.)

We want this discussion to be constructive and forward looking. And for that, we need your interest and participation. Thank you in advance for enrolling in the March 13 WIHI!

I hope you'll join us! You can enroll for the free broadcast here.

In the streets? No, in the gutter.

I have reached a new level of disgust with regard to the international political activities of Hadassah Women's Zionist Organization of American.  Recall that HWZOA has overseen the systematic failure of Hadassah Medical Organization.  But rather than acknowledging any flaws in its own governance and oversight of this crown jewel of Israel's health care system, it seeks to impose blame on the government of Israel.  While there are clearly policy changes that are needed to help the role of non-profit hospitals like Hadassah, it is totally inappropriate for the American Jewish community to expend political capital in this self-serving manner.  I hope that Israeli politicians see this tactic for what it is.

Here's the latest missive from the head of HWZOA:

Now is the time to stand in solidarity with Hadassah Medical Organization (HMO). My previous emails and our dedicated HMO UPDATE webpage have kept you informed about the recovery effort at HMO. But now is the time for you to take action. Negotiations with the Government of Israel continue, but to date have not resulted in the changes we need to keep Hadassah's hospitals thriving and serving the people of Israel. 

On Tuesday, March 18, a large tent will be erected outside the Knesset in Jerusalem. Hundreds of supporters—including physicians, nurses, former patients, and concerned citizens—will make their voices heard. I will be leading a contingent of HMO Board members, HWZOA past presidents, Hadassah Office in Israel and representatives from Hadassah International, Youth Aliyah and Young Judaea. We will present a petition in support of HMO with more than 20,000 signatures to the Government of Israel, and invite Members of the Knesset to visit the tent and meet with us. On the same day, we are calling for a show of solidarity at the Israeli Consulate in New York City.

There are three important ways to show your love of Hadassah and your support of Israel’s finest medical organization, even if you are not in the New York area.

1.     Sign the petition today.
It must be signed by Wednesday, March 12.
2.      Join our virtual rally! ! Take a “selfie” (photo of yourself) holding a sign in support of Hadassah's hospitals, and post it on Hadassah’s Facebook page. And get together with members of your chapter and take a group “selfie” for Facebook.
Suggested signs:

o    I stand with Hadassah's hospitals

o    Support Hadassah's hospitals

o    I want fair treatment for Hadassah's hospitals

o    I’m with Hadassah's hospitals 

3.    Tweet your support to #ImWithHadassahHospitals. Encourage your family and friends to do the same.

Time to undo the readmission penalty damage to safety net hospitals

Over two years ago, I summarized a research paper from Karen E. Joynt and Ashish K. Jha at Brigham and Women's Hospital that suggested that a one-size-fits-all readmission rate penalty policy would have the unintended consequence of harming safety net hospitals.  They said:

Conclusions—Given that many poor-performing hospitals also have fewer resources, they may suffer disproportionately from financial penalties for high readmission rates.  As we seek to improve care for patients with heart failure, we should ensure that penalties for poor performance do not worsen disparities in quality of care.  (Circ Cardiovasc Qual Outcomes. 2011;4:53-59.)

To the best of my knowledge, these concerns were never addressed by the federal government, or by state governments applying similar standards through Medicaid.

Now comes this thoughtful argument by Richard Fuller at 3M Clinical and Economic Research in an article entitled: "Payment policy bias against high Disproportionate Share Hospitals (DSH)."An excerpt:

The bias against high Disproportionate Share Hospitals (DSH) apparent in the CMS payment policy is particularly concerning. This comes at a time when Medicare DSH payments are being directly adjusted as part of ongoing reforms and Medicaid DSH payments are being cut nationally in accordance with the Affordable Care Act. This heightened sensitivity brings urgency to the discussion of how to correct for the perceived SES [socioeconomic status] bias, specifically whether measures reflecting SES should be included in the current risk-adjustment formula. If additional measures reflecting SES are to be considered, it will be important to separate the effects that may be attributed to generally lower performance in low income areas from those attributable to the complexities of treating a challenging population. In other words, can the risk adjustment method help us distinguish whether hospitals that care for poorer patients perform worse because they don’t do a good job, or because their patients are more difficult to care for?

His summary:

Risk adjustment for provider rates that account for SES should include additional clinical and demographic factors that can be shown to improve predictive performance. In addition, those additional factors should be incorporated into a model that is based on continuous variables rather than a categorical model based on peer groups.

Will it be a whitewash?

In five days, the president of the University of Illinois is due to receive the report from the Vice President for Research that will evaluate the circumstances surrounding the use of the University's name and reputation in support of a private medical equipment supplier.  Recall that the VP was charged to "conduct a methodical assessment of policies, guidelines, procedures and practices, and where corrective changes are required we will take the appropriate action."

As I have noted:

Karisa King and Jodi Cohen at the Chicago Tribune have published an excellent story about how some doctors and admininstrators decided to use the name and reputation of the University of Illinois in support of a medical device company.  With access to internal emails, it becomes clear that an explicit decision was made to do so by very high-ranking officials:

Benedetti, the head of surgery, sought advice and permission from Jerry Bauman, interim vice president for health affairs, and Dr. Dimitri Azar, dean of the College of Medicine, according to an Oct. 23 email obtained under the Freedom of Information Act.

"On one side it would be a lot of free publicity for our program, on the other side we could be criticized to be included in an industry generated campaign," Benedetti wrote. The two responded separately that the visibility would be good for the program.

It will be revealing to see how the report deals with the question of how these people recklessly gave themselves an exemption from the specific language of the Campus Administrative Manual:

In general, the University cannot permit its image to be used in any commercial announcement, in a commercial or artistic production, including the World Wide Web or in any other context where endorsement of a product, organization, person, or cause is explicitly or implicitly conveyed.

There are two possibilities.  The one offered to date by the University's spokesperson is that participating in the ad was "a good faith effort" to promote expertise that has "demonstrably beneficial outcomes for patients," but the execution was perhaps not well thought-out.

With such a conclusion, the University would be admitting that its policies are a nullity.  As long as someone felt that the business interests of the hospital would be well-served, the rules could be abrogated.

The second possibility is that these three high administrative officials are found to have knowingly violated the University's rules but get a mild slap on the wrist or less.  In such a case, the University would likewise be admitting that its policies are a nullity: As long as you are high up enough in the organization, the rules need not be followed.

Well, there is a third possibility, that the University sends a message--through appropriate punishment--that the ethical rules under which it operates are real.  As I noted back in January:

Regular readers know that I tend to operate in a no-blame mode, i.e., be hard on the problem and soft on the people.  But when someone has violated the public trust in an institution to support the commercial goals of a private company, they have shown such poor judgment that consideration must be given to terminating their employment.

And how much more so now that we know that this equipment manufacturer has provided cash support and has other close relations with UIC faculty.

I'm guessing we won't see much in this report that indicates a serious look at the recent violations.  The University has invested too much in its robotic surgery program to take an action that might suggest that any aspect of that program is untoward, influenced by the equipment manufacturer, or unsupported by clinical evidence.  Likewise, the University has made it clear that the highest ranking official who rules on matters of potential conflicts of interest can have deep and close financial relationships with firms whose interests overlap UIC's.

So, what's it to be?  Whitewash #1 or whitewash #2 or a clean break from past practices?  The resolution will eventually reflect on the Board of Trustees, some members of which are especially known for their public service reputation.  Will they stand by and watch as the reputation of their University is again dragged through the mud?

Let's spend time calling instead of coding

Way back in 2008, my friend and colleague John Halamka wrote this post about the transition from ICD-9 to ICD-10 codes, the codes that are used to record clinical activity for the purpose of reimbursement by Medicare and other insurers. John is the unquestioned national expert in health care IT systems. At the time, he was "enthusiastic about the adoption of new standards that enhance semantic interoperability. The use of modern vocabulary standards such as ICD-10 improve administrative efficiency, enhance the ability of decision support systems to enforce guidelines, and enable a more granular reimbursement process." But, he also pointed out the logistical and training problems inherent in this kind of transformation:

The overall cost of implementing this change is technological and operational. For example, there must be modifications to existing training curriculum as well as claim submission and payment policies to ensure no adverse impact to the revenue cycle. I anticipate a real challenge to train, recruit, and retain ICD-10 savvy coders.

Well, that may have been one of the biggest understatements in health care for the decade.  As I have traveled the country, few issues have raised more concern than this one. 

By 2011, John Halamka was warning us:

If Congress was doing its job of regulatory oversight, they would sponsor hearings to learn what payers and providers are actually spending on ICD-10 conversion. Costs for consulting services alone run into the millions. This does not count the application software conversion, training and education, and other "in-house" costs. At our medical center, we would be paying $380,000 according to HHS estimates. Instead, the marginal cost of ICD-10 will be in excess of $5m. For multi-hospital systems, the costs may exceed $100m.

A Congressional review of transition costs would turn the regulatory impact assessment on its head. Costs could easily become double the estimated benefit savings.

With ICD-10, the government is perpetuating a reimbursement system that is far too complex. We spend more than any other country on healthcare administrative overhead. The Medicare Claims Processing Manual, for example, is over 4,000 pages in length. The reimbursement system needs simplification to bring the cost of this function in line with other industries.

In 2013, he noted:

We learned from healthcare.gov that end to end testing with a full user load and complete data set is important to validate the robustness of an application. ICD-10 go live for every provider and most payers (other than Workman's Comp) is 11 months away. Does CMS have time for a full end to end test of all functionality with its trading partners? I am concerned that not enough time is available. Will most payers and providers be ready to process transactions on October 1, 2014? Maybe. Will new documentation systems, clinical documentation improvement applications, and computer assisted coding to ensure auditable linkage between the clinical record and the highly granular ICD-10 billing data be in place? Doubtful. Will RAC audits discover that not enough time was available for training, education, testing, innovation, and workflow redesign? Certainly. The risk of a premature ICD-10 go live will be the disruption of the entire healthcare revenue cycle in the US. The consequences of a delay in enforcing ICD-10 use are minimal.

There have been lots of similar requests to the government to slow this down, but the CMS administrator is holding firm to the latest deadlines:

Providers, payers and claims clearinghouses can look for no relief from the looming, Oct. 1 compliance deadline for the nationwide conversion to the ICD-10 family of diagnostic and procedural codes, the head of the CMS said Thursday.  

Tavenner's comments triggered a quick, and apprehension-filled, response from the American Medical Association.

“The AMA is deeply concerned that Medicare does not have a back-up plan if last minute testing demonstrates anticipated problems with this massive coding transition,” said AMA President Dr. Ardis Dee Hoven.

Many doctors are still awaiting software updates from vendors and risk not having sufficient time to test those updates when they finally do arrive, Dee Hoven pointed out. “Testing is needed to discover problems and resolve them prior to the go live date. The slightest glitch in the ICD-10 rollout could potentially cause a billion dollar back-log of medical claims that jeopardizes physician practices and disrupts patients' access to care,” she said.

So, the training goes on.  Barnes Jewish Hospital in St. Louis, for example, has prepared thousands of "tip" cards like the ones above to help people remember some of the details required under the new coding environment.

Meanwhile, this has become a big business.  Here in Boston, one IT firm is even advertising on public radio (!) that is it available to help health care facilities manage the transition.  (I guess that just shows how many health-care-related NPR listeners live here!)

I guess this is all necessary, but I'm not sure I really understand why.  For example, if the trend in the US really is towards global, or capitated, payments, why do we need record-keeping of such detailed clinical activities?  Also, this new required level of detail creates immense compliance risks for doctors and hospitals and enforcement needs for regulators. It seems to me that the chance of inadvertently coding something wrong has just increased by two or three orders of magnitude.

 The CDC summarizes:

• There are nearly 19 times as many procedure codes in ICD-10-PCS than in ICD-9-CM volume 3
• There are nearly 5 times as many diagnosis codes in ICD-10-CM than in ICD-9-CM
• ICD-10 has alphanumeric categories instead of numeric ones
• The order of some chapters have changed, some titles have been renamed, and conditions have been grouped differently

Given the government's recent focus on enhanced billing compliance, we can expect many more investigations and financial penalties.

I'd prefer that providers be allowed to spend more time calling their patients and talking to them about their conditions rather than coding their illnesses.

Meanwhile, there is some humor in the situation:

Three wrongs don't make a right, even for Deans

An important comment was submitted on my post below, in which I argued that the service of the University of Illinois Dean of Medicine on the Board of Directors of a medical device and pharmaceutical company was unwise.  Recall that I said:

I seek to present facts and context that, in my mind, again raise the issue of governance and propriety:  How can this person exercise a proper duty of care and loyalty to both institutions, not only in terms of time commitment, but also in terms of the overlapping scientific research and clinical interests of the two organizations?  I raise this issue not to accuse anyone of misbehavior, or engaging in conflicts of interest that result in personal gain, but as a matter of public trust.

The comment was as follows:

The governance rules that allow external leadership positions are not unique to UIC or to the city of Chicago. As examples, the Dean of Weill Cornell Medical College in New York is on the Board of Directors of Bristol-Myers Squibb Pharmaceutical Corporation, and the Dean for the University of North Carolina School of Medicine is on the Board of Directors of Eli Lilly. This is an issue that extends beyond the city limits of Chicago – a city that I call home and I love.

I checked it out.  Laurie Glimcher, the Dean at Weill Cornell, is indeed on the Board of Directors of the Bristol-Myers Squibb Pharmaceutical Corporation. She is an expert in rheumatology, immunology, skeletal biology and translational medicine.  You can understand why BMS would welcome her to their board, as they have a large presence in the immunology field.  She is also on the Board of the Waters Corporation, a laboratory equipment company.

Questions akin to those I have raised about UIC have been raised about Dean Glimcher's dual roles:  This article, for example, was published in 2012 in the Cornell Daily Sun:

In addition to receiving an academic salary from Cornell, WCMC Dean Laurie Glimcher receives six-figure salaries annually from pharmaceutical giant Bristol-Myers Squibb and the Waters Corporation, a laboratory equipment company, according to the companies’ filings with the U.S. Securities and Exchange Commission. There are no allegations that Glimcher has used her position at Weill to do anything illegal or to steer the school to purchase those companies’ products.

But leading research ethicists say such close financial ties to big business can prove harmful in less obviously wrong ways. Having a medical college’s top official personally and financially invested in the profits of the medical industry can stifle academic integrity and stain medical research with a subtle, if perhaps unconscious, corporate bias, they said.

“If medical faculty know they’re basically reporting to Bristol Myers Squibb, does that make them change what they do? Be more afraid to criticize certain priorities?” said Roy Poses, president of the non-profit Foundation for Integrity and Responsibility. “There’s a lot of evidence to [cause] concern [that it does] alter their behavior.”

Poses, who is also a professor of medicine at Brown University, pointed to board directors’ legal obligation to help the companies they work for.

“If you’re sworn to uphold these shareholders and you are good buddies with the management, are their interests always completely aligned with [those of] students and faculty [and] patients of the medical school?” Poses said.

William L. Roper is dean of the School of Medicine and vice chancellor for Medical Affairs at the University of North Carolina at Chapel Hill (UNC) and CEO of the UNC Health Care System.  He is an expert in pediatrics and social medicine.  He is not on the board of Eli Lilly.  But he is on the Board of Directors of DaVita, Inc., which provides a complete range of dialysis treatments and support services for patients.  DaVita reports: "Dr. Roper brings substantial expertise in the medical field, an in-depth understanding of the regulatory aspects of our business as well as clinical, financial and operational experience."  Dr. Roper is also on the Board of Directors of Express Scripts Holding Company, which provides pharmacy benefit management services and clinics healthcare account administration services.

As in the case of the UIC Dean, there is no evidence of any attempt to hide Glimcher's or Roper's relationships.  As you would expect, they are fully disclosed in both university and company documents.

So what's the problem?  It's the same one I mentioned at the start:  How can this person exercise a proper duty of care and loyalty to both institutions, not only in terms of time commitment, but also in terms of the overlapping scientific research and clinical interests of the two organizations?

In a era of diminished public confidence in our health care institutions and in the pharma companies, why introduce additional relationships that have the potential to erode public trust?  There are plenty of ex-Deans with scientific expertise to be tapped by public companies.  And for these three Deans, there will be plenty of commercial board opportunities when they step down some day.

Jubilee Project presents The Mixtapes

The Jubilee Project continues to provide us all with heartwarming videos.  Check out this one.  Or watch it here:

 

Addressing Patient Wait Times with Systems Thinking

MIT SDM Systems Thinking Webinar Series

Addressing Patient Wait Times with Systems Thinking

Ali Kamil, SDM '12, MIT SDM and Harvard Kennedy School of Government Graduate Student 

Dmitriy Lyan, SDM '11, Senior Product Manager, Amazon Web Services

Date: March 10, 2014
Time: Noon – 1 p.m. EDT
Free and open to all

Register

About the Presentation

This webinar will present findings from a 12-month study that explores the use of systems thinking to address the prolonged and highly variable patient wait times. The research was conducted at the LV Prasad Eye Institute (LVPEI) in Hyderabad, India, which has provided care for more than 15 million people—over 50 percent of whom were served free of charge.

The presentation will:

• Outline the challenges faced by the LVPEI's outpatient department (OPD) clinics, which serve 65 to 120 patients per day, with patient wait times ranging from 45 minutes to 6 hours;
• Review time and motion studies of 430 patients at four LVEI OPDs;
• Describe how researchers used qualitative and quantitative data to capture the operational structure of LVPEI OPD clinics and simulate daily patient flow;
• Share contributions from key stakeholders;
• Reveal the analysis used to quantify the impact of service demand, patient scheduling, and resource allocation factors on patient wait times and service quality; and
• Summarize outcomes, including identifying the key policy levers that determine LVPEI's effectiveness.

A question and answer session will follow the presentation.

Maybe they thought it was 267,153 kangaroos

Federico Girosi, Associate Professor in Population Health at the School of Medicine, University of Western Sydney, posted the following story on Facebook:

We just submitted a paper to BMC Public Health. This was their reply:

"Thank you for your recent submission of the manuscript "People with multiple unhealthy lifestyles are less likely to consult primary healthcare. Evidence from 267,153 Australians". We have now looked over your manuscript and we feel that it is out of scope for the journal. However, we do feel that the manuscript may be suited for another of our journals, BMC Veterinary Research."

How not to do fund-raising

I suppose it's not fair to pile on two years later, but I was taken aback when I recently came across this solicitation video produced by Parkland Memorial Hospital as it was engaged in a major capital campaign.  It stands as an example of poor taste in fund-raising, with regard to both the imagery and words chosen. When we consider that the hospital obviously spent a lot of money on this production as it was going through major turmoil, in terms of its quality of patient care, we really have to question the priorities of those then in charge.

Here's the video:

A parent advises us to listen

My regular readers know how impressed I am with the folks at Children's Mercy Hospital in Kansas City.  They are fully engaged in process improvement efforts and are always committed to doing better and better.

Part of the program is a series of podcasts hosted Dr. Jason Newland (Medical Director, Patient Safety and System Reliability) designed to help keep the staff up to date on latest developments and ideas.  Here's the latest one, in which Terrence Gallagher, a parent and member of the Children’s Mercy Family Advisory Board, talks with Jason about his family's experience in the hospital.  It comes complete with background noise from his child!

Please listen, in particular, to Terrence's observations starting at about minute 7:50.  The topic is about the importance of listening--staff listening to parents, but also listening to one another.

When a cancer center is not one

I don't know who the author of this blog is, but s/he has a thoughtful view of the "business plans" that seem to characterize a lot of cancer centers being set up by hospitals across the country.  It's called, "Your cancer center is just a box."  Here's the excerpt:

I had the opportunity to discuss the idea for a new cancer center with a healthcare system. The team consisted of the CFO and COO, a couple of the medical directors, several VP’s from service lines, and the marketing team.

Everyone had their list of all the inputs that they feel needs to be a part of the new cancer center. The technology, the specialists, the types of treatments. They even had a preliminary design that they had worked through with an expert architecture firm.

My honest opinion is that I have NOT seen anything in this presentation that shows you understand how families, businesses, patients, and consumers of cancer services want to use your “stuff.”

The room went silent. I could tell I hit a nerve. I told them that what they have is very manageable, but it isn’t anything special. It’s a box. It has a bunch of things in it. Yet it is still a box. I don’t do boxes.

The beauty comes when you know why people walk through your front door. . . . It comes in having an intimacy in understanding how they think, feel, react, and what they expect from your services. It comes in anticipating their needs before it even comes up and delivering the content in a manner that is easy, simple, and available.

If that is what you want, then I suggest you scrap what you think you know, and begin with the people that matter the most, those that live in your community.

Robotic surgery: The Sequel?

The first time was such a hit, why not do it again?  I refer, of course, to the marketing ploy used by Intuitive Surgical, Inc. when it introduced robotic surgery in the prostatectomy scene.  Go with direct-to-consumer advertising to give the impression that the results from robotic surgery are better than from manual laparoscopic surgery.  Make sure the early-adopter surgeons are on board and publicly proclaiming their great results.  When it comes to men and the functioning of their penises, you can predict the result.  Who can argue with that kind of success?  The stock market rewarded the company handsomely.

But now the market for prostate surgery is saturated, so it's time to move to another type of surgery that raises anxiety, this one for women.  Hysterectomies are the target.  Again, let's use the heartfelt comments of patients to support the cause, while being soft on scientifically valid clinical studies.

Further, give the impression that there is extensive use of the machine for hysterectomies by saying, "100% of the top 50 cancer hospitals in the United States use the da Vinci Surgical system."  While true, this statement omits what I surmise to be the actual case, that the vast majority of those machines are used for prostate surgery, not for hysterectomies.

Here, though, the professionals have spoken, and the words are not good for the company.  Look at these comments by James T. Breeden, president of ACOG:

Many women today are hearing about the claimed advantages of robotic surgery for hysterectomy, thanks to widespread marketing and advertising. Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.

At a time when there is a demand for more fiscal responsibility and transparency in health care, the use of expensive medical technology should be questioned when less-costly alternatives provide equal or better patient outcomes. 

At a price of more than $1.7 million per robot, $125,000 in annual maintenance costs, and up to $2,000 per surgery for the cost of single-use instruments, robotic surgery is the most expensive approach. . . . A study of over 264,000 hysterectomy patients in 441 hospitals also found that robotics added an average of $2,000 per procedure without any demonstrable benefit.  

Aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that they are the best choice. Our patients deserve and need factual information about all of their treatment options, including costs, so that they can make truly informed health care decisions. Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated.

Who will prevail in the court of public opinion, the company or the professionals?  In light of the dearth of coverage of this issue by the medical press, I would ordinarily put my money on Intuitive. On the other hand, some Wall Street analysts now seem less sanguine. Suraj Kalia at Northland Capital Markets noted yesterday:

Intuitive now has to engage in lengthier discussions on price negotiations, both on capital sales & instruments. This is a shift over the last 6 - 9 months. Capital sales continue to be tough, and it is unclear to us what turns this tide around.

It seems some hospitals are asking for discounts (10% and more) on instruments and a global risk sharing program. Part of this discussion is compounded by an unused capacity of about 30% or so in U.S. hospitals. 

More importantly, it seems hospitals are asking Intuitive Surgical to be a "partner" in their robotic surgery practices, rather than engage in aggressive marketing & pricing. Some hospitals, as was explained to us, have asked Intuitive to help in "rationalizing" procedures in order to "optimize" outcomes. Optimizing outcomes would have the benefit of making robotic surgery look cost-effective and clinically better, albeit at the expense of "weeding" out extra procedures giving the industry a bad rap.

Lowering prices in order to meet quotas results in margins being squeezed. Don't lower prices and you have a situation where hospitals perforce have to cut back on procedures or capital sales in order to justify economic viability.

Huddling in New York City

It's National Patient Safety Week, and I was honored to be invited to Metropolitan Hospital Center in New York City to give a talk on clinical process improvement.  Before that, I had a chance to visit parts of the hospital to see some of their initiatives. 

Led by Chief of Service Gregory Almond, the Emergency Department has been looking at many of their processes.  One of the simplest and most effective steps was a decision to conduct huddles, not just once per day, but every two hours.  These might last only two or three minutes, but everyone is involved, including the security folks as well as clinicians.  Problems are identified, assignments are given, and follow-ups occur regularly.  The whole process is documented on a white board in real time, providing a visual cue to everyone on the floor as they walk by.

You see some of the protagonists above, including Irene Quinones, Patient Safety Associate; Jean-Paul Menoscal, Associate Chief of Service for Emergency Medicine; and Samrina Kahlon, the hospital's Patient Safety Officer.  (I'm pleased to report, too, that Samrina is an alumna of the 2012 Telluride Patient Safety Camp!  It's great to see her progress to such a position of responsiblility in a hospital.)

My kind of town, Chicago is.

For those of us in the rest of the country, Chicago has always set a certain standard when it comes to conflicts of interest, and why should health care there be any different?  You've been reading about such concerns at the University of Illinois.  Now, check out this recent story by Kristen Schorsch and Andrew Wang at Crain's Chicago Business.  Does this meet the smell test in your view?  An excerpt:

For at least 15 years, Cook County Circuit Court Judge Lynn Egan has sat on the boards governing a south suburban hospital while it regularly has hired her brother's law firm. 

Chicago-based Pretzel & Stouffer has represented Palos Community Hospital in almost half of the 170 cases involving the hospital filed over that period in the law division of the circuit court, according to a Crain's review of court records. From 2011 to 2013, Matthew Egan, a partner in the firm, represented Palos in at least 15 cases before his sister's judicial colleagues, most of them involving medical malpractice or personal injury.

Lessons from the Aga Khan in Canada

One of the world's great leaders is not the head of a national government. He is the leader of a religious faith.  The Aga Khan is the spiritual head of the Ismaili Muslims, a Shia sect reaching back to the days of the Prophet Mohamed.  In this role, and through the Aga Khan Development Network (AKDN), he has addressed issues of the elimination of poverty, access to education, and social peace in a pluralist environment.  He was recently recognized for this and other accomplishments by being invited to address the Canadian Parliament.

The speech is a remarkable exposition of the potential power of pluralism in a deeply disturbed world.  It also helps us non-Muslims understand a bit more about the history and divisions and commonalities in this faith, something seldom covered in the mainstream media.  It is on this latter topic that I present some excerpts, as I found it a fascinating and helpful discussion for my understanding of the world:

First then, a few personal words. I was born into a Muslim family, linked by heredity to the Prophet Muhammad (may peace be upon him and his family). My education blended Islamic and Western traditions, and I was studying at Harvard . . . when I became the 49th hereditary Imam of the Shia Imami Ismaili Muslims.

The Ismaili Imamat is a supra-national entity, representing the succession of Imams since the time of the Prophet. But let me clarify something more about the history of that role, in both the Sunni and Shia interpretations of the Muslim faith.

The Sunni position is that the Prophet nominated no successor, and that spiritual-moral authority belongs to those who are learned in matters of religious law. As a result, there are many Sunni imams in a given time and place. But others believed that the Prophet had designated his cousin and son-in-law, Ali, as his successor. From that early division, a host of further distinctions grew up — but the question of rightful leadership remains central. In time, the Shia were also sub-divided over this question, so that today the Ismailis are the only Shia community who, throughout history, have been led by a living, hereditary Imam in direct descent from the Prophet.

The role of the Ismaili Imam is a spiritual one; his authority is that of religious interpretation. It is not a political role. I do not govern any land. At the same time, Islam believes fundamentally that the spiritual and material worlds are inextricably connected. Faith does not remove Muslims — or their Imams — from daily, practical matters in family life, in business, in community affairs.

Faith, rather, is a force that should deepen our concern for our worldly habitat, for embracing its challenges, and for improving the quality of human life.

---

Our work has always been people-driven. It grows out of the age-old Islamic ethic, committed to goals with universal relevance: the elimination of poverty, access to education, and social peace in a pluralist environment. The AKDN’s fundamental objective is to improve the quality of human life.

Amongst the great common denominators of the human race is a shared aspiration, a common hope, for a better quality of life. I was struck a few years ago to read about a UNDP survey of 18 South American states where the majority of the people were less interested in their forms of government, than in the quality of their lives. Even autocratic governments that improved their quality of life would be more acceptable for most of those polled than ineffective democratic governments.

But the sad fact behind so much instability in our world today is that governments are seen to be inadequate to these challenges.

--

Against this background, let me move on to the broad international sphere, including the role of relations between the countries and cultures of Islam — what we call the Ummah — and non-Islamic societies. It is central to the shape of global affairs in our time.

I would begin by emphasising a central point about the Ummah often unseen elsewhere: the fundamental fact of its immense diversity. Muslim demography has expanded dramatically in recent years, and Muslims today have highly differing views on many questions.

Essential among them is that they do not share some common, overarching impression of the West. It has become commonplace for some to talk about an inevitable clash of the industrial West and Islamic civilizations. But Muslims don’t see things in this way. Those whose words and deeds feed into that point of view are a small and extreme minority. For most of us, it is simply not true. We find singularly little in our theological interpretations that would clash with the other Abrahamic faiths — with Christianity and Judaism. Indeed, there is much that is in profound harmony.

When the clashes of modern times have come, they have most often grown out of particular political circumstances, the twists and turns of power relationships and economic ambitions, rather than deep theological divides. Yet sadly, what is highly abnormal in the Islamic world gets mistaken for what is normal. Of course, media perceptions of our world in recent years have often been conveyed through a lens of war. But that is all the more reason to shape global conversation in a more informed direction.

The complexity of the Ummah has a long history. Some of the most glorious chapters in Islamic history were purposefully built on the principle of inclusiveness — it was a matter of state policy to pursue excellence through pluralism.

This was true from the time of the Abbasids in Baghdad and the Fatimids in Cairo over 1,000 years ago. It was true in Afghanistan and Timbuktu in Mali, and later with the Safavids in Iran, the Mughals in India, the Uzbeks in Bukhara, and Ottomans in Turkey. From the 8th to the 16th century, al-Andalus thrived on the Iberian Peninsula — under Muslim aegis — but also deeply welcoming to Christian and Jewish peoples.

Today, these Islamic traditions have been obscured in many places, from Muslims and non-Muslims alike.

Perhaps the most important area of incomprehension, outside the Ummah, is the conflict between Sunni and Shia interpretations of Islam and the consequences for the Sunni and Shia peoples.
This powerful tension is sometimes even more profound than conflicts between Muslims and other faiths. It has increased massively in scope and intensity recently, and has been further exacerbated by external interventions. In Pakistan and Malaysia, in Iraq and Syria, in Lebanon and Bahrain, in Yemen and Somalia and Afghanistan it is becoming a disaster.

It is important, therefore, for non-Muslims who are dealing with the Ummah to communicate with both Sunni and Shia voices. To be oblivious to this reality would be like ignoring over many centuries that there were differences between Catholics and Protestants, or trying to resolve the civil war in Northern Ireland without engaging both Christian communities.

What would have been the consequences if the Protestant-Catholic struggle in Ireland had spread throughout the Christian world, as is happening today between Shia and Sunni Muslims in more than nine countries? It is of the highest priority that these dangerous trends be well understood and resisted, and that the fundamental legitimacy of pluralistic outlooks be honoured in all aspects of our lives together — including matters of faith.

In memoriam: Robert C. Moellering, Jr.

This announcement arrived from Harvard Medical School:

Dr. Robert C. Moellering, the HMS Shields Warren-Mallinckrodt Professor of Medical Research and a renowned infectious disease researcher, was physician-in-chief and chair of the Department of Medicine at Beth Israel Deaconess Medical Center from 1981 to 2005. He died on Feb. 24, 2014, at the age of 77.

Dr. Moellering made major advances in the investigation, treatment and prevention of infectious diseases, in particular studying the mechanisms of antibiotic action and bacterial resistance to antimicrobial agents. His work led to the development of laboratory tests that are now used worldwide. He was also the first to show the clinical effectiveness of penicillin-gentamicin combination therapy for enterococcal endocarditis, now the standard of care for this infection.

A dedicated teacher, researcher and clinician who trained generations of clinicians and academic physicians, Dr. Moellering’s career spanned more than four decades at HMS.

All true, but I'd like to add some more.

When I arrived as CEO of BIDMC in 2002, there was a lot of turmoil, but at the center of things stood a person of great integrity, calmness, and kindness.  He was not only Chief of Medicine, but he was also head of the faculty practice plan.  He had been Chief at New England Deaconess and was one of a very view "Deac" people to be asked to serve in a senior capacity in the newly merged hospital.  The reason for this was clear: Few people were as highly respected on "both sides of the aisle" as Bob.

I enjoyed working with him.  He was honest and clear, and his commitment to clinical care, research, and teaching were unmistakable.  Although he was in a leadership position, that position was not important to his self-image.  In an academic environment known for ego, he was remarkably unegotistical.  Perhaps that is why is was such a good teacher.  I remember attending a grand rounds session he taught about MRSA one day: In 45 minutes I learned more about the subject than I imagined possible. The talk was lucid, well organized, approachable regardless of your level of knowledge, and full of good humor and modesty about what was understood and what was still unknown.  That is was a substantive tour de force was no surprise given Bob's expertise. That it was a pedagogical tour de force was something else still.  I talked about it for days afterward.

As told on another blog:

I wanted to share two quotes from Dr. Moellering and a final one from Dr. Jerome Groopman delivered on the occasion of Dr. Moellering stepping down as Chair of Medicine.

“I served for the better part of 24 years as chairman of the department and also ran the faculty practice plan here. But I view administration as nothing more than a means to an end--a means to create more effective clinical and teaching programs in the department, and a way to ensure that I could have an impact on the training of physicians and the internal medicine house staff.”

“Teaching is the most important thing we do. Imparting knowledge to the next generation of physicians is incredibly important. It’s a privilege we are given in the academic setting. Not only does it give you a tremendous sense of satisfaction in that you’ve done something worthwhile, but it gives you some immediate gratification because you can watch students who go on to successful careers.”

Dr. Jerome Groopman: "How many of us has he supported on his shoulders? How many of us has he helped to move forward when we felt we didn't have the energy or endurance to continue? Those shoulders have carried enormous burdens, carried with a quiet confidence, through all the difficult times, the growth of the department, the merger…. Bob is loved because beyond his intellect, beyond his knowledge, beyond his hard work, he is filled with a unique form of kindness. Bob has true generosity of spirit. He sees your success as his success. This is his legacy."

At that same stepping-down party in June of 2005, Bob quoted a poem, and I asked if he would mind sending it to me.  He did, and I have saved the letter all these years:

Dear Paul:

The poem I quoted last Thursday evening was entitled "Ithaca," and was written by Constantine Cavafy.

"Hope the way is long.
May there be many summer mornings when,
With what pleasure, with what joy,
You shall enter first-seen harbors...

Keep Ithaca always in your mind.
Arriving there is what has been ordained for you.
But do not hurry the journey at all.
Better if it lasts many years;
And you dock an old man on the island,
Rich with all you’ve gained on the way,
Not expecting Ithaca to give you wealth.

Ithaca gave you the beautiful journey.
Without her you would not have set out.
She has nothing more to give you."

Bob entered many first-seen harbors, and some of us were lucky to travel with him for a portion of the voyage.

A matter of public trust

Several weeks ago, I raised the issue of whether it was appropriate for the Dean of the College of Medicine at the University of Illinois to be on the Board of Novartis, a major biomedical corporation. My concern was quickly slapped down by a University spokesperson, who said, in part:

The University of Illinois views Dean Azar’s service on the Board of Director of Novartis as appropriate, given that the conflict of interest and commitment is well-managed. The UIC leadership and Dean Azar have commendable records of integrity and in dealing with conflict of interest issues associated with external activities."

I wonder if the University did any research into this matter before giving this response.  I'm going to present some of my own research, derived solely from public sources.  In so doing, please understand that I in no way seek to denigrate the exceptional scientific and clinic record of the Dean.  I merely seek to present facts and context that, in my mind, again raise the issue of governance and propriety--both for the University and for a company that has itself faced questions of ethics and governance:  How can this person exercise a proper duty of care and loyalty to both institutions, not only in terms of time commitment, but also in terms of the overlapping scientific research and clinical interests of the two organizations?  I raise this issue not to accuse anyone of misbehavior, or engaging in conflicts of interest that result in personal gain, but as a matter of public trust.

As noted by Joan Miller, Chief and Chair of Ophthalmology at Massachusetts Eye and Ear Infirmary:

As we try to sort through COI and the relationship between industry and academe, we want to do what is in the best interest of our patients and the public good. We want to maintain the positive advantages of collaboration and philanthropy, especially in educational grants and research, while holding ourselves free from possible bias. We must treasure and ensure the public’s trust. No one can do it better than we can. 

The Novartis business plan

How did Dmitri Azar end up on the Board of Novartis?

In April 2011, Novartis announced its acquisition of Alcon for $51.6 billion:

“With Alcon, we will add eye care as a fifth growth platform alongside innovative pharmaceuticals, generics, vaccines and diagnostics, and consumer health,” said Dr. Daniel Vasella, Chairman of Novartis. “The strong Novartis presence around the world, including in emerging markets, will open new growth prospects for the combined businesses. Novartis and Alcon can be expected to profit from the combination of complementary research and development activities and ultimately benefit patients suffering from eye diseases worldwide.”

“The new Alcon Division will cover more than 70 percent of the eye care segment with more than USD 9 billion in annual revenue,” said Joseph Jimenez, CEO of Novartis.

Less than a year later, in February 2012, Dr. Azar was elected to the Board.  Clearly his credentials in the field could not be questioned and would be of value to the company as it pursued its new line of business:

Dr. Azar, a US citizen, is Dean of the College of Medicine and Professor of Ophthalmology, Bioengineering, and Pharmacology of the University of Illinois at Chicago, USA. He holds a medical degree from the American University of Beirut, Lebanon, an Honorary MA from Harvard University and an Executive MBA from the University of Chicago, Booth School of Business. Dr. Azar is an internationally recognized ophthalmic surgeon and prolific researcher. He has been named one of The Best Doctors in America and one of the Castle Connolly Top Doctors in America annually since 1994. He holds multiple committee positions with the American Academy of Ophthalmology, is a member of the American Ophthalmological Association, and sits on the Board of Trustees of the Chicago Ophthalmological Society and the Association of Research in Vision and Ophthalmology. He has received multiple leadership awards, including the 2009 Lans Distinguished Award from the International Society of Refractive Surgery.

Dr. Azar was well known at Alcon.  After joining the faculty at the University in 2006 as Head of the Department of Ophthalmology & Visual Sciences, he received, in 2007, an Alcon Research Institute award, "represent[ing] a unique example of industry support by identifying exceptional ophthalmic scientists and awarding each with $100,000 unrestricted grants to further their research endeavors."

The relationship grew. In the Illinois Statement of Economic Interests submissions dated 2008, 2009, 2010, 2011, 2012, and 2013, he reported receiving over $5000 for each of the previous years as a consultant to the company as well as getting honoraria in excess of $500.

University purchases of Novartis equipment and supplies

And the relationship has grown in both directions.  Three phacoemulsification machines (for cataract surgery) were purchased from Alcon.  I do not have information about the timing of this purchase decision. If it occurred during his tenure, did Dr. Azar recuse himself from this issue, given his relationship with Alcon? There are competing companies for this type of equipment.  Was the original purchase of equipment a sole source purchase, or were competitive proposals received?  I note that University purchases from around this time were criticized in a report from the State Auditor General--"The University did not review and approve sole source justification forms as required by University Policy."--but it is not clear whether that criticism was directed at this specific purchase.

This kind of decision regarding capital equipment has long-term financial ramifications.  After purchasing the three phacoemulsification machines from Alcon, the University was locked into buying the supplies for these machines from the same company.  For example, in 2009, it entered into a sole source purchase for such supplies.

Purchase of intraocular lens implants, probes, drapes, crescent knives and retractors for Alcon Phaco machines for the period of July 1, 2009 through June 30, 2011. 

Cost:  $1.1 million

This purchase is a sole source because the items are patented and compatible with existing equipment from the only manufacturer. Currently the Hospital owns three Alcon Phaco machines that are used to soften, shatter and remove cataracts. Alcon equipment is a standard in the industry for removal of cataracts in cataract surgery. The supplies are required for the operations of these machines. 

Likewise, in 2013, the University entered into a similar sole source purchase:

The University awarded a contract for PHACO System Packs to Alcon Laboratories, Fort Worth, TX, for an estimated $2,925,000.

Purchase from Alcon Labs their Infinity and Constellation PHACO system packs for the 3 Alcon Phaco machines (a Phaco Machine is a ultrasonic device used to soften, shatted and remove cataracts) currently used in the Hospital Operating Room.

The University has determined that this purchase is only economically available from this source because the item or service is copyrighted or patented and is not available except from the holder of the copyright or patent. 

The same equipment was purchased for the Millennium Park Eye Center, the site where Dr. Azar sees patients.

Leading edge technology purchases

In 2012, the University acquired a new LenSX laser for cataract surgery from Alcon, among the first in the Midwest.  Did Dr. Azar recuse himself from this issue, given his relationship with Novartis?  The Alcon femtosecond laser is not the only one on the market.  Again, I do not have documentation as to whether the purchase was a sole source procurement, or whether a competitive process was used.  But this article suggests that the former was the case, quoting a member of Dr. Azar's faculty, who (as I discuss below) receives financial support from Alcon:

Another consideration for Dr. de la Cruz in choosing the LenSx Laser was the university's prior experience with Alcon. "The technology fits well in our operating room, because we already have the Infiniti phaco system," Dr. de la Cruz says. "We were confident the company would provide good support and maintenance."

While it is common for academic centers to invest in state-of-the-art technology for research purposes, it is still appropriate to ask if purchase of this machine was a good business choice for the University.  Did such a conversation take place among University officials?  If so, did Dr. Azar recuse himself from the discussion of this issue, given his relationship with Novartis?  Under whose authority did the purchase take place? According to this 2011 article, the cost-effectiveness of this approach is not yet proven:

The final discussion point for FLACS is cost. These laser machines with integrated OCT or Scheimpflug technology will add considerable cost to a currently standard procedure. The final cost -benefit analysis will be more complete once long-term data on the laser systems is available. Because the size of the laser platforms is quite large, many surgery centers may require an extra step of moving a patient from the preoperative laser suite to the operating room. This will also be an extra cost in both time and efficiency.

A Medscape article also found:

Femtosecond laser-assisted cataract surgery (FLACS) represents a potential paradigm shift in cataract surgery, but it is not without controversy. Advocates of the technology herald FLACS as a revolution that promises superior outcomes and an improved safety profile for patients. Conversely, detractors point to the large financial costs involved and claim that similar results are achievable with conventional small-incision phacoemulsification. . . . While in its infancy, FLACS sets out the exciting possibility of a new level of precision in cataract surgery. However, further work in the form of large scale, phase 3 randomised controlled trials are required to demonstrate whether its theoretical benefits are significant in practice and worthy of the necessary huge financial investment and system overhaul. Whether it gains widespread acceptance is likely to be influenced by a complex interplay of scientific and socio-economic factors in years to come. 

Use of this equipment was not covered by Medicare at the time of purchase by the University:

[P]reliminary published research has not been scientifically powerful enough to persuade private insurers or Medicare -- which pays for about 8 of every 10 conventional cataract procedures in the United States -- to compensate providers for the extra cost of using femtosecond lasers in cataract surgery. Practitioners are prohibited from billing Medicare beneficiaries for costs that the federal insurance program will not pay.  

"[But] in truth, you can't add femtosecond surgery [to your practice]," William W. Culbertson, MD, a professor of ophthalmology at Bascom Palmer Eye Institute in Miami, Florida, said. "You would lose money on every procedure." 

Or, as summarized here:

The use of a femtosecond laser during cataract surgery is a new and exciting option but an extremely expensive one. It raises important questions about reimbursement as well as the technology’s potential. 

There have also been concerns raised about training residents and fellows on this equipment.  At the University of Illinous, this became the topic of a research study:

Ophthalmology residents and fellows at the University of Illinois at Chicago performed a retrospective study comparing their experiences performing cataract surgery with and without the femtosecond laser. The 6-month results were reported at the 2013 meeting of the Association for Research in Vision and Ophthalmology.

The researchers concluded that resident surgeons on the initial learning curve for cataract surgery are capable of safely learning standard phacoemulsification techniques along with use of the LenSx Laser system. In addition, the LenSx Laser system appears to allow cataract extraction with less energy, which may result in improved long-term outcomes.

Was Alcon involved in sponsoring this research?  As noted in this February 2014 advertising supplement, Dr. de la Cruz--the lead faculty author for the research project--has received funding from the company (although his 2013 Statement of Economic Interests contains no hint of that.  Perhaps it will be included in the 2014 report.)

Did Dr. Azar recuse himself from any involvement in the decision to conduct the research or any aspects of it, given his relationship with Novartis?

Alcon involvement in University education programs

Beyond these matters, it is well documented and disclosed that Alcon supports continuing medical education programs at the University. Here's one example:

As Joan Miller notes in her comment above, this is not unusual and--properly disclosed--can be of value to all.  That's not the issue at the University of Illinois.  The issue at UIC is whether there is anything about the dual positions held by Dr. Azar that lead to his involvement in the decision to invite or include Alcon--particularly in preference to other ophthalmic equipment suppliers--to be the sponsor of such programs.

Conclusion

I for one believe it would take a superhuman effort on the part of the Dean to recuse himself from every financial analysis, purchase decision, research decision, and educational decision at the University of Illinois that has the potential to involve Novartis or its competitors.  As noted, I am in no way asserting or implying that this superb physician and researcher has improperly benefited or that he has failed to disclose under state law or University policy.  What I am saying is that both institutions require a person to exercise a proper duty of care and loyalty to each of them.  It is inconceivable to me that this is possible in this case, not only in terms of time commitment, but also in terms of the overlapping scientific research and clinical interests of the two organizations.

It is this matter that faces the Trustees of the University of Illinois.  It is this matter of public trust.