Do they deserve a medal?

The United Hospital Fund has posted a quarter page ad in the New York Times, entitled "They deserve a medal."  The ad celebrates hospital trustees whose "leadership and dedication make life better for all New Yorkers," and there will be a presentation in their honor at the Waldorf-Astoria.  This is an annual event by the UHF.

I firmly believe that hospital trustees are dedicated and thoughtful folks, who devote time, energy, and money to support local institutions.  We should indeed be grateful for their devotion to the cause.  But it's been my experience that many hospital governing boards fail to address fully the patient experience.

So, I wondered what, other than personal commitment, the boards of these hospitals have achieved on that front.  I tapped the government's Hospital Compare website to explore just a few of the named hospitals.

I looked at the grades for patient experience and found the following for St. Barnabas Hospital. (The first column is the hospital, the next is a comparison to New York hospitals, and the last column is a comparison to the national average.)

The hospital was below both the regional and national average when it came to getting information to patients about what to do during recovery at home, how well patients understood their care when they left the hospital, the percentage of patients who gave the hospital the highest ratings, and the percentage of patients who would recommend the hospital.

Ditto for Wyckoff Weights Medical Center:

In contrast, Eastern Long Island Hospital did well, matching or beating the average in all four categories:

Not fair, some will claim.  For one thing, the Hospital Compare numbers don't show a trend.  But the data are reasonably current (from July 2013 to June 2014) and are collected in a uniform manner across the region and country.

I join the UHF in praising these trustees for what they have done.  And perhaps a number of trustees mentioned in its advertisement have been champions for the kind of results we all seek.  If so, it would be great if the UHF could connect the dots between individual trustee action, governance processes they have put in place, and the results for patients.

Tribal warfare

A comment on my post below about unnecessary testing before cataract surgery presents a striking example of one problem in medicine--the inability of specialists from different disciplines to agree on and incorporate best practices in patient care:

In my experience this process (pre-op testing prior to cataract surgery) is completely driven by anesthesiology.

At my institution we have fought to change this process to no avail so recently we started having topical days without any anesthesia staff present. We give the patient a mild oral anti-anxiety medication (if needed) and do the short case under topical conditions. Without anesthesia monitoring the cost is even lower.

Snapping defeat from the jaws of victory

What is it about opthalmologists and cataract surgery?  If there were ever a success story in the world of medicine it is this:  Better and more consistent quality than years ago delivered at a remarkably lower cost.  But it seems like the profession insists on ways to make it more expensive.

I have discussed one such "innovation," the femtosecond laser, and the thousands of dollars in direct consumer cost that it entails and that has been authorized by CMS, the Medicare agency.

Now Michelle Andrews at Kaiser Health News summarizes a recent NEJM article.  Excerpts:

Requiring patients to get blood work and other tests before undergoing cataract surgery hasn’t been recommended for more than a dozen years. There’s good reason for that: The eye surgery generally takes less time than watching a rerun of “Marcus Welby, MD” — just 18 minutes, on average. It’s also incredibly safe, with a less than 1 percent risk of major cardiac problems or death.

Yet more than half of Medicare patients received at least one pre-operative test in the month before undergoing surgery to remove cataracts in 2011, a recent study found.

“Their patients [tested] were no sicker or older,” says Catherine Chen, an anesthesiologist at the University of California, San Francisco, and the lead author of the study. “It suggests that it’s habit or practice patterns.”

Cataract surgery used to take a few hours and require general anesthesia. In those days, preoperative testing made more sense, says Chen. Now people often receive only a topical anesthetic eye drop to numb the eye or sometimes a local anesthetic that may include a sedative for relaxation.

But research shows that today, pre-operative testing for cataract surgery doesn’t result in fewer adverse events or better surgical outcomes, regardless of a patient’s health, says Chen.

Where is the American Academy of Opthalmology on such issues?  Who stands for the patients?  Where is CMS, and why do they allow this pattern of testing?  Who stands for the costs incurred by the American public?

The cost that is hiding in plain sight

Jack Sullivan at Commonwealth Magazine summarizes recent findings surrounding high deductible health insurance plans.  I covered some of these points back in November, and it is helpful to have them restated with the latest analyses. The American Academy of Pediatrics has likewise made the case strongly. Jack's lede:

U.S. News & World Report is out with its annual index on health insurance and its impact on the economy. To the surprise of few, many of the costs are declining or at least not rising at the dizzying pace they had been.

But much of those savings are going into the pockets of businesses and insurance companies, with consumers picking up an increasing share of out-of-pocket expenses because many companies are going to higher deductible plans to offset hikes in premiums. That, according to new studies, is actually making people sicker because they cannot afford or don’t want to pay the thousands of dollars required for visits or higher drug co-pays.

More:

For most American workers, the passage of the Affordable Care Act was good news and bad news. Many more now have access to insurance. But while premiums have risen only 3 percent in recent years, the shifting of the cost burden through deductibles, coinsurance, and copays has heaped a heavier burden on those who buy the insurance, especially families in low-income and blue-collar jobs such as construction or trades. Between 2000 and 2013, out-of-pocket expenses by consumers nearly doubled to $1,217 per person, with the biggest jump coming after the Great Recession in 2009.

Regulators and health plans posit that higher out-of-pocket expenses force consumers to make more prudent choices in accessing health care. In practice, subscribers are avoiding many necessary treatments and drugs rather than pay for them out-of-pocket.

But the problem clearly isn’t limited by age or income. Part of the formula for getting everyone covered is for health plans to get everyone into the pool and the way they do that is through lower premiums. And the way to lower premiums is through higher deductibles.The plans calculate that younger, healthier workers will be attracted to the lower premium and not pay attention to what it may cost them if they actually get sick.

It is a cost that is hiding in plain sight.

Is this what you call success?

“I am not sure how to explain it. It's hard to tell exactly what's going on, but whatever it is, it looks like it's good."

Well, that's sure a ringing endorsement of the Pioneer ACO experiment.  Medicare is so intent on proving that this ACO model is a success that they have to use words like this (reported by Melanie Evans in Modern Healthcare) to describe the results.

Previously, though, they acknowledged that the model does not work.  Let's go back to December, when Jordan Rau at KHN reported:

Health care systems experimenting with a new way of being paid by Medicare would have three extra years before they could be punished for poor performance, the federal government proposed Monday.

As I noted at the time:

The rule comes because many organizations have withdrawn from the ACO scheme or threaten to do so.  They have concluded that the risks just aren't worth the potential gain.  So now, CMS tries to solve that problem by essentially removing the risks.

This kind of reversal represents a kind of muddied thinking that is an indication of ideological public policy formulation. 

Melanie's report is rife with CMS's reported contradictions, starting with the lede:

Medicare says the pilot did well enough to expand. But it's unclear how the participants got the savings and to what extent others can replicate the success. 

Let's look at the criteria for program expansion under the Affordable Care Act:

The program did not add to Medicare's budget and the quality of care did not suffer.

That's sure a low legislative hurdle.  But what actually happened?  Read these sentences together and try to make sense of them.  They raise huge questions about the structure of the program and the methodology used to evaluate it.

As a group, the ACOs reduced spending on hospitalizations, which is one of the primary aims of the model. 

One perplexing result from the CMS analysis was a drop in spending for primary care office visits.

McWilliams' analysis found an increase in outpatient spending but a shift away from care in hospital-based outpatient centers.

An independent review of Pioneers' first two years offered few insights into why primary care spending declined or what may have contributed to success among those that saved money. 

Researchers with L&M Policy Research who analyzed the organizations' results said it was hard to identify strategies that helped to save money. 

I really wish CMS would focus instead on its own practices that encourage billions of dollars in wasteful hospital investment in high-cost technologies.  That's where to find the savings, not in these poorly constructed and evaluated programs.

How do I invest?

Here is a new, groundbreaking EHR vendor with an amazing website.  It offers the most honest presentation in the industry.  I'm sure it will do well, and I write this post as I wait on hold with the VC people to learn how to invest.

Excerpts:

At the confluence of extortion and conformity lies Extormity, the electronic health records mega-corporation dedicated to offering highly proprietary, difficult to customize and prohibitively expensive healthcare IT solutions. Our flagship product, the Extormity EMR Software Suite, was recently voted “Most Complex” by readers of a leading healthcare industry publication.

The Extormity EMR software suite requires wholesale, revolutionary workflow change that dramatically impacts practice patterns. Our slow and painful change process significantly interrupts patient volumes and revenues, and this cumbersome transformation can only be appreciated in hindsight and with the aid of prescription medication (which can be prescribed via the Extormity EMRX Upgrade Module and Pharmacy Interface Pack).

Under the Extormity Uptime Guarantee section, we see:

** This section of the site is experiencing technical difficulty. Please check back in 30 days…better make that 45 days, just to be safe.** 

Taking steps to achieve more steps

I've noted the unsupported assertions of many wellness programs, but it's also important to acknowledge the interventions that can make a difference.  Here's an excellent article from the European Respiratory Journal that documents how affixing pedometers to people with COPD can make a difference in their health.  From the abstract:

Physical inactivity is a cardinal feature of chronic obstructive pulmonary disease (COPD), and is associated with increased morbidity and mortality. Pedometers, which have been used in healthy populations, might also increase physical activity in patients with COPD. COPD patients taking part in a 3-month individualised programme to promote an increase in their daily physical activity were randomised to either a standard programme of physical activity encouragement alone, or a pedometer-based programme. 

Both groups had comparable characteristics at baseline. The pedometer group had significantly greater improvements in: physical activity 3080±3254 steps·day(-1) versus 138.3±1950 steps·day(-1) (p<0.001); SGRQ -8.8±12.2 versus -3.8±10.9 (p=0.01); CAT score -3.5±5.5 versus -0.6±6.6 (p=0.001); and 6MWD 12.4±34.6 versus -0.7±24.4 m (p=0.02) than patients receiving activity encouragement only. A simple physical activity enhancement programme using pedometers can effectively improve physical activity level and quality of life in COPD patients.

Oregon CCOs on WIHI

Madge Kaplan notes:

The next WIHI broadcast — Leaning In: Oregon's Coordinated Care Organizations (CCOs) — will take place on Thursday, May 7, from 2 to 3 PM ET, and I hope you'll tune in.

Our guests will include:

• Chris DeMars, MPH, Director, Systems Innovation, Oregon Health Authority - Transformation Center
• Ronald Stock, MD, MA, Director of Clinical Innovation, Oregon Health Authority - Transformation Center
• Trissa Torres, MD, MSPH, FACPM, Senior Vice President, IHI

Far from the epicenter of Washington, DC, and the federal government’s efforts to expand health insurance coverage and usher in health care delivery and payment reform, states are moving ahead with amazing innovations of their own these days. Medicaid waivers, which offer states running room to experiment with public dollars, are one big reason. And one big example of what’s possible is unfolding in Oregon.

No stranger to trail-blazing with transformative ideas and initiatives, Oregon’s latest efforts to provide better care and value to nearly one million Medicaid recipients will be the focus of the May 7, 2015, WIHI: Leaning In: Oregon’s Coordinated Care Organizations (CCOs). The groundwork and the enabling policies and legislation for CCOs have been several years in the making, and the careful shaping of the program is leading to some impressive results. Since 2011, emergency department visits are down 21 percent, preventable hospital admissions among adults for complications associated with diabetes have decreased nearly 10 percent, and enrollment in Patient-Centered Primary Care Homes has increased 55 percent.

And what about Oregon putting itself on a global budget with a fixed rate of growth — how is that going? We’re going to find out about the money, the care, the measures, how the 16 CCOs across the state function as one system, the innovative use of community health workers and more, thanks to two key people in the know from the Oregon Health Authority’s Transformation Center: Chris DeMars and Ronald Stock. They’re eager to share what they’re learning and to field your comments and questions. IHI’s Trissa Torres will offer commentary about this work, discuss how it relates to the Triple Aim and changes in primary care happening everywhere, and suggest ways to apply what’s happening in Oregon to your own state and setting.

Please join us on May 7. You can enroll for the broadcast here. 

I would have guessed they were Tories

A true story I heard from a colleague in London:

My nine-year-old daughter came up to me and said, "Dad, Kate is voting for the Labour party."  

"How do you know that?" I asked.

"I just heard on the radio that she's into Labour."

Success in surgery? Not so fast.

Richard Harris at NPR interviewed Marty Makary on the subject of how to know if your surgery was successful.  The summary in a nutshell:

For 99 percent of people in America, when they go in to have surgery, the outcome [of that operation] is not measured. Nobody's keeping track. So I'm amazed at how one-fifth of the economy, [the share accounted for by the healthcare system], functions with so little measure of its performance.

I've noticed this, too, but an even more insidious fashion.  Lately, I've been reading published, apparently peer reviewed, medical papers about certain surgical procedures in which the authors (usually the surgeons in question) claimed that the surgery was successful.  But I've learned of a number of high profile cases of this sort in which the patient or the organ donor later suffered long-term complications that were not evident in the few short weeks following the procedure.

My problem here is piercing the veil of physician and hospital self-interest and patient confidentiality to present those cases to you. I'm working on it, though.  I welcome stories from my readers that fit into this category, particularly when patients or families are willing to share their confidential information or when the information is otherwise public (e.g., in court documents).

First aid class turns out to be dangerous

This could be one of the strangest stories I've read in a while, from The Globe and Mail. Here's the lede:

Randy Theriault spent 30 years captaining ships and was praised as an expert seafarer who honed his craft through experience. So, when the Nova Scotia man landed a well-paying job as first mate on a massive fishing vessel this spring, only one small hurdle stood in his way – a first aid course that seemed to be merely a formality.

Now his grieving family is struggling to understand how the 48-year-old Mr. Theriault could die suddenly of pneumonia during a first-aid course designed to deal with such situations. On the morning of April 17, after suffering through fever, shortness of breath, nausea and chest pains while attending the week-long Maritime Advanced First Aid course at Nova Scotia Community College, Mr. Theriault was found dead at a Port Hawkesbury bed and breakfast where he had been staying.

Later in the story:

The college says it is investigating what went on inside the classroom. The first-aid course is run by St. John Ambulance, which says Mr. Theriault exhibited normal vital signs during the course, although he “complained from time-to-time of flu-like symptoms.” In a statement, St. John Ambulance spokeswoman Clara Wicke said “instructors agreed to provide Mr. Theriault with reasonable accommodation to complete his certification by allowing him to make up missed time at a later date.”

That statement has upset Mr. Theriault’s family, who say text messages in the days leading up to his death indicate he was faced with the choice of staying in class or failing the course because it was not offered regularly. 

They want to know how Mr. Theriault could die while learning how to deal with emergencies such as respiratory ailments at sea, which includes pneumonia.

The family questions the assertion that Mr. Theriault displayed normal vital signs in the class. In one of his final texts to Ms. Tobin, he says he has a fever, and that he felt embarrassed about his laboured breathing in the classroom.

(Thanks to Dr. Susan Shaw for citing this story on Twitter.)

Like Canada, like the world

“When asked to think about their end-of-life planning, 75% of Canadians express a desire to die in their own homes. Yet in actual fact, 70% of Canadians die in hospital."

That's the summary of recent poll, as reported in the Ottawa Sun. I imagine there would be similar results in much of the developed world.

The article continues:

How we want our lives to end is not how they’re ending. That’s a tragedy. It’s also a clear sign that we need to adjust our public policy priorities to better reflect the needs of the people that the system was created to serve.

Right.

(Thanks to Dr. Susan Shaw for forwarding the article.)

Courage to Live

A remembrance from my friend John Brock:

On May 26, 2012 I died.

I didn't almost die; I died. My heart stopped pumping blood. In most of the world and through most of history that means death. No pulse. No breath. Dead.

I was fortunate, privileged some would say, to be on a street in a wealthy suburb with easy access to some of the best treatment in the world. I live in a place where we fight death. At great expense we maintain a huge apparatus of people and buildings and technology to wage that war.

A cell phone call was made. Police cars, fire trucks, and an ambulance showed up in minutes. Trained and dedicated people jumped out of those vehicles. They electrocuted me. They strapped me into a machine that pushed so hard on my chest it broke my ribs as it forced blood through my body. They raced me to a hospital. They blasted my body back to life.

That was my body. Living was another process.

Someone saw me and knew me. She called my pastor who dropped what she was doing and came to support Sheila, my wife, who was, without any preparation, making life and death decisions with strength, with love and trust for me, and with faith and hope for whatever was going to happen next.

Over the next weeks, Sheila and our children would sit with me listening to the technology. One machine breathed for me; another recorded every blip of my restarted heart; another fed me; another pumped water and death-defying drugs into me; another massaged my legs; another, buried in the bed, shifted the pressure on my back ever so gently.

There were a lot of machines and a lot of drugs involved.

Friends and family celebrated when I moved my tongue; and when I raised my arm, and when I sat up, and when I walked. Later, when I could speak, folks came to see me and to listen to me talk, even though much of what I had to say was nonsense. Pain killers and even temporary oxygen starvation will do that to a person.

I am deeply grateful for all the people and technology that waged war against death on my behalf. They helped me beat death…but they didn’t bring me into life.

What brought me into life was faith, hope, and above all from the love in everything around me.

Rilke captured some powerful and precious some 100 years ago. He wrote:

Animals see the openness of creation with their whole eyes.
Our eyes, turned back upon themselves, encircle and seek to snare creation, setting traps for freedom.
The faces of the beasts show what truly IS to us: we who upend the infant and force its sight to fix upon things and shapes, rather the freedom that the beasts occupy, that openness that lies so deep within their faces, free from death!
We alone face death.
The beast, death behind and God before, moves free through eternity like a river running.

Having died, I no longer fear dying.

What I fear is a return to a state of not living—of being so concerned about what I’ve done; what others have done to me; what others have thought of me; and of what I will do or others will do or what others will think—that often I cannot see the openness.

Three years on, and a lot of recovery behind me, I long to gaze into that openness. And sometimes I find a moment, an hour, a day when I can.

So I write this for myself each morning as a reminder:

Have the courage to live.
To do what is right.
To do what is important.
To act with thought and awareness.
To act with kindness.

Thieves of State

I'm pleased to recommend to you a book I just read, Sarah Chayes' Thieves of State, Why Corruption Threatens Global Security.  Here are some excerpts from a review provided by Budd Shenkin:

Chayes' thesis is that failed states are not really failed states, they are countries captured and run by criminal associations. Their modus operandi is the shakedown at all levels. Therefore, the strategy of the United States – first to establish stability and only afterwards to root out corruption – does not and cannot work. Oppression is not a good strategy for the long term.

Chayes starts with Afghanistan, where she started out working for NPR and then left to work for an NGO headed by the older brother of one Hamid Karzai. She soon discovered that the Karzai's could easily have been directed by Francis Ford Coppola, the only problem being to decide who was Michael, who was Sonny, and who was Fredo. She literally watched the CIA hand over large bills to one of the brothers wrapped in aluminum foil. She did not witness the obtaining of a receipt.

 

Chayes' thesis to end corruption first is based on obtaining the good will of the people. They are the ones who are actually oppressed and extorted. Chayes cites four or five “mirror” would-be ruler advisers, the most familiar being Machiavelli, who have sought to bring reason to rulers through the ages. They all say the same thing, that you have to be basically fair to the people, responsible for them in rooting out the corruption of your subordinates, etc. If you don't act this way, they will revolt, and that the revolt will often be based on an extreme religious element, such as Martin Luther. Viewed this way, one comes to think of the Taliban and other Islamic movements as a typical reaction to official corruption.  

 

It's nice to think of a Westphalian world where states respect each others' boundaries and internal politics, where legitimacy is respected inside and outside of the state. Unfortunately, with these kleptocratic states, that's not going to be possible. They will experience upheaval and threaten those around them and increasingly the rest of the globalized world. It's not a bad idea to try to help the states develop internal legitimacy and coherence. But to help them, the helpers need to understand both those states and the mirror-writers and history. There is little evidence that this is happening at anything like the scale we need.

It's a powerful argument in a short book.

The healthier your hospital the better your outcomes

I recently attended an Oslo meeting of the Dr Foster Global Comparators, an international group of hospitals that have been working together to share data and insights related to quality and safety.  What makes the group particularly interesting is their attempts to draw comparisons across national boundaries. This is no easy task, given the different manner (and for different purposes) in which countries collect administrative and clinical data; but the group has made good progress in several areas—notably GI, stroke, sepsis, and orthopaedics. At this session, I met committed and interesting folks from the UK, US, Denmark, Norway, China, Saudi Arabia, the Netherlands, and Australia.

While all the presentations were engaging, the one that most intrigued me was one offered by two surgical fellows from Imperial College, Christopher Nicolay and Stephen Williams. As I understand it, Christopher conducted much of the original research, and Stephen is now going to pick up on it and carry it forward. I’ll just present a quick outline here, as I’m confident they will formally present the results elsewhere, and I don’t want to steal their thunder. 

The session was entitled, “The healthier your hospital the better your outcomes.” The hypothesis being tested was whether there might be a correlation between organizational health and clinical outcomes. The fellows first drew on the literature to help think about the elements of organizational health in hospitals. An initial definition by Chris Argyris (1958) set the stage: “A healthy organization is one that enables mature human functioning.” Then, a quote from Christin Shoaf et al (2004): “Organizational health blends the pursuit of individual wellness with organizational effectiveness to yield a strategy for economic resilience.”

Using interviews with many folks, a thoughtful model was derived for assessing organizational health for 22 acute care NHS trusts in the UK. Those assessments were then correlated with patient outcomes like mortality rates and critical incident reporting. Sure enough, there was a positive correlation.

While we’ll all look forward to the formal publication of these results, I can already predict two reactions to this kind of study. The naysayers will say that the concept of organizational health is just too fuzzy to quantify, much less correlate with measure of clinical outcomes (which, they will also say, are themselves too uncertain to use and rely upon.)

Others of us who have run hospitals, visited others, and studied others have seen that the quality of the work environment inevitably has an impact on patient outcomes. An organization in which staff wellbeing, effective communication, resilience, efficiency, and servant leadership are extant tends to be very good as a learning organization and tends to be more alert to the needs of its patients and more adept at clinical process improvement.

Stephen’s next step is to try to extend the research across national boundaries and investigate whether similar patterns might show up around the world. Congratulations to these two young men for taking on this topic and helping us gain deeper insights into the matter. 

Who's paying the bill?

This was sent by a friend.  I think it's a great idea.

Dr Foster offers advice on performance measurement

The folks at Dr Foster recently published a thoughtful paper about the uses and abuses of clinical data for the purposes of measuring performance.  While their thoughts are directly applicable to government regulatory agencies, they are also worth considering with regard to benchmarking within the profession and by hospital governing bodies. The paper is well worth a look.

They note that while measurement of performance in the healthcare sector is essential for transparency and accountability, and to support improvement, performance measurement can have a range of unintended adverse consequences:

Tunnel vision: Focusing on aspects of clinical performance that are measured and neglecting unmeasured areas;

Adverse selection/inequity: Avoiding the most severely ill patients or excluding disadvantaged groups;

Bullying: Intimidating staff to achieve performance targets or to adjust data;

Erosion: Diminution of intrinsic professional motivation as a key driver of high quality healthcare;

Ceiling effect: Removing incentives for further improvement and potentially influencing top performers to reduce quality;

Gaming: Distorting the process of care in order to meet targets or manipulating data to misrepresent actual performance;

Distraction: Challenging, obfuscating or denying data which suggests underperformance instead of fixing performance problems.

They suggest countermeasures to help avoid these adverse consequences:

1. Make data quality as important as hitting targets – By initiating a long term audit programme to tackle misreporting and incomplete or inaccurate data recording.
2. Measure the context not just the indicator – Keeping performance measures under constant review, perhaps by multi-disciplinary specialist groups, including Royal Colleges and patient organisations.
3. Avoid thresholds and consider the potential to incentivise ‘gaming’ in the design of metrics – Performance measures should be assessed according to the likelihood they will encourage abuse. Thresholds should be avoided wherever possible.
4. Be more open – Making data underlying performance management widely available and promoting ongoing assessment of the degree to which metrics are being gamed.
5. Apply measures fairly – In order to recognise legitimate mitigating factors such as resources and pressures outside the control of the organisation.

Is solidarity forever?

As the US remains splintered about the rights of the public with regard to health care, things have often been different in Europe.  But is this changing?  Richard Saltman and colleague offer an interesting article in the Israel Journal of Health Policy Research. The title: "Health Sector Solidarity: A Core European Value but with Broadly Varying Content."

Here's the abstract:

Although the concept of solidarity sits at the center of many European health sector debates, the content of the services and benefits that solidarity ensures has changed considerably over time. In prior economic periods, solidarity covered considerably fewer services or groups of the population than it does today. As economic and political circumstances changed, the content of solidarity changed with them. Recent examples of these shifts are illustrated through a discussion of health reforms in Netherlands, Germany and Israel (although not in Europe, the Israeli health system is structured like other European social health insurance systems). This article suggests that changed economic circumstances in Europe since the onset of the 2008 financial crisis may require a further re-set of the content of services covered by solidarity in many European health systems. A key issue for policymakers will be protecting vulnerable populations as this re-design occurs.

Creating the safe place for patients and caregivers

Here's a beautiful video presented by David Mayer, Vice President of Quality and Safety for MedStar Health, as an attachment to a column he recently posted on Educate the Young,  He says:

High Reliability science is one area we are looking to for answers to systems failures in healthcare. High reliability organizations stress the importance of “Stopping the Line” when a worker senses something doesn’t feel right. The concept has been shown to help reduce harm in many high risk environments. What if something similar existed for communication concerns in the healthcare environment?

The following short video, entitled Please See Me, created by patients and caregivers for patients and caregivers, offers a possible solution. Can “Please See Me” become that safe space, where patients and family members can stop the line and share those words if they feel their needs are not being heard or addressed? At the same time, can caregivers use the same phrase when they feel they are not being understood by patients and family members?

The next bend up in the cost curve: Rising prices for old proven drugs?

A anesthesiologist friend sent me the note below. If accurate, as this doctor says, "The expense of the surgical robot will pale in comparison to the coming tsunami of overpriced drugs!"  I'm hoping some full-time health care reporters take a look, as this seems to be a major story that has been neglected.

A short while ago, our office-based OR discovered it could not get neostigmine* from our usual suppliers but could find only an exorbitantly expensive "new" one. I emailed back and forth with the company whose product we used to use and all they could tell me was "per FDA regulations we can no longer market this drug."  The price we had to pay went from a few dollars to over $160/vial.   So I did a little digging and found out the following:

This relates to an FDA initiative to get "unapproved drugs" off the market.  Sounds like a great idea, right?  Well, these unapproved drugs are the ones we've been using safely for decades and were grandfathered in to not needing to go through the FDA approval process that started in the early 1960s.  So . . . some drug companies have realized that they can jump through the hoops to get one of these drugs approved, at which point all other companies' version of the drug is now "unapproved" and cannot be sold.

The same thing has happened with colchicine, which has gone from 5 cents/pill to $5/pill, and all kinds of other drugs are in this pipeline, e.g. epinephrine, and it's only a matter of time before the same will happen to atropine, calcium, bicarb, ephedrine, etc.  This is an unmitigated disaster for healthcare spending.

The initiative is described on Bloxiverz.com (the "new approved" version of neostigmine) (not "new improved") under the "FDA Initiative" tab.  [And here's the link to the FDA site.]

I did a little sleuthing and found this article on Medscape from last year.  The story set forth there is that the unapproved supplies of neostigmine were becoming scarce:

Bloxiverz is the first FDA-approved version of neostigmine, which has been on the market as unapproved, grandfathered products under the Food, Drug, and Cosmetic Act of 1938. Flamel expects to launch Bloxiverz in July 2013 in 0.5 and 1.0 mg/mL strengths.

The cost difference between the branded and generic version remains to be seen.

"Based on our marketing experience, we believe that hospitals will welcome the addition of Bloxiverz as an FDA-approved version of neostigmine," Mike Anderson, Flamel's chief executive officer, said in statement.

He noted that unapproved versions of neostigmine have been in "short supply for nearly a year, which may add to the need for a reliable source of FDA-approved product."

I'm not sure, but this document appears to be the summary of the drug company's proposal to have its version of neostigmine approved.  (The timing of the report seems just right, but the company's name is deleted from the document.)  Sure enough, the agency mentions that the drug has been in use since the 1930s and that there is no reason to doubt its efficacy. The report seems to be one of "the hoops" mentioned by my friend.

So, the question is why the unapproved version was in short supply. There seems to be a correlation with knowledge by other companies that an approved version is on the way.  Look at this article from an investment analyst:

[The FDA guidelines are such] that it will typically remove unapproved product from the market in approximately one year from the approval date of an NDA (5/31/2013) led many investors to believe that the FDA had notified the companies privately that they had to wind down inventories and prepare to leave the market entirely at some future date. This was cleared up today for me, when I learned that Cardinal Health, a distributor of West-Ward Pharmaceuticals' unapproved formulation of neostigmine, had updated its National Drug Code information to indicate that neostigmine methylsulfate supplied by West-Ward would no longer be available for marketing after September 30, 2014. 

So, while Mr. Anderson correctly noted the shortage, his firm's filing, was in essence, the cause of the shortage.

The investment analyst offers his prognostication of the financial benefit of this change in market conditions:

I believe that this new information is clear public evidence that the neostigmine competitors to Flamel's BLOXIVERZ were told to cease marketing of their products by the end of September. From channel checks, I estimate that there was approximately six weeks of inventory of unapproved product in the channel and as much as six weeks of inventory in-process at the two unapproved manufacturers. As this inventory is wound down, I would expect Flamel's BLOXIVERZ, as the only remaining player, to continuously gain this share, and I conservatively project more than 50% share by September 1 and close to 100% share by the end of that month. 

While I may be off a few weeks on the timing of the inventory drawdown, I am pretty certain that Flamel's BLOXIVERZ will be the only neostigmine product on the market after September 30th and that the product is truly transformational for the company, as the drug should drive annual earnings power of $1.00-$2.00 per share beginning in the fourth quarter and in 2015 and 2016. Based on my discussions with industry experts and a review of drug pricing during periods of market dominance, I believe that BLOXIVERZ could generate revenues of approximately $150 million in 2015 and more than $200 million in 2016, with peak revenues of $250 million later that year.

Neostigmine methylsulfate is used to reverse the muscular blocking agents following surgical procedures that require anesthesia. It is a critical drug that must be used, and therefore does not require much of a selling effort, and Flamel is able to sell the drug with just two employees, who are mainly responsible for order entry and supply management. As such, margins are quite high in the 65-70% range, after manufacturing costs and royalties tied to previous owners of a Flamel subsidiary of 20%.

I imagine there is some good reason for the FDA's unapproved drug regulations, but it is hard to imagine that no one in the federal government understood the potential cost impacts of this policy direction.

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* Per Wikipedia: Neostigmine is used to improve muscle tone in people with myasthenia gravis and routinely in anesthesia to reverse the effects of non-depolarizing muscle relaxants such as rocuronium and vecuronium at the end of an operation, usually in a dose of 25 to 50 μg per kilogram.