Wednesday, April 30, 2014

An unleashed demand for health care services

It slipped by so fast that I almost missed it.  It wasn't, after all, the main point of this news report by NPRs John Ydstie on All Things Considered.  It was on the economy as a wholeHere's the audio recording.

Listen at minute at 2:57 and hear the story of the one growth area of the economy:

It looks as thought the advent of Obamacare and the provision of insurance to people who previously didn't have it has unleashed demand for health care services that simply wasn't there before.

In fact, spending on health care grew in the first three months of the year at an astonishing annual rate of nearly 10%.

This is no surprise to many of us.  As we saw in Massachusetts when universal access was provided, if you give people health insurance, they will use it.  In fact, at heart, that's why we want to give them insurance.  In the past, people without health insurance would avoid important visits to the doctor, or important visits to the hospital, or important consumption of drugs.

There are some who might argue that the fee-for-service rate design by which many providers get paid accounts for this.  But, no.  There is actually less fee-for-service care than there was in the past, as a number of insurers and providers have moved to more risk-based payment plans.

There are some who might argue that consolidation in the health care industry accounts for upward price pressure.  While that should be a concern over the coming years, I don't believe that it has yet had the full effect that it will.

No, what's happening now is much more simple.  People are going to the doctor sooner when they have symptoms.  Some portion of those people are sick and need more extensive care.  In the past, this group would not have gone to the doctor, and they would not have gotten the extensive care.  Some percentage would have gotten sicker and sicker at home and eventually would have shown up in emergency departments.  Without the full course of treatment they are now getting as insured patients, we would have "saved" a lot of money in treatment. Some, though, would have died prematurely or suffered from extended morbidity.

Others are having regular preventative diagnostic tests, like mammograms.  Early detection of breast cancer results in earlier treatment--radiation, surgery, chemotherapy--adding to the nation's health care bill.  (We saw this in Massachusetts.)  In the past, their disease would not have been noticed until it was too late, again "saving" a lot of money in treatment.

The human cost under the old regime was unconscionable, and we have done the correct thing to give people access to insurance and care.  The dollar cost, though, had to increase.

The problem here is not the result.  The problem was that the Administration, as part of its political strategy to get the legislation passed, glossed over this fact.  In fact, the promise was that access to insurance would be paired with lower costs.  The Administration's plan, all along, was that these costs would be covered by the imposition of a value-added tax.  But the political environment has changed, and the chance of such a tax is very low.  So the tension between access and costs will grow.  Over time, choices will be made.

In the short run, the solution imposed will be to charge consumers directly for a greater portion of their health care costs, with high deductible health plans (HDHPs).  This direction creates important issues and can interfere with our achievement of several of the Institute of Medicine's six aims of care--safe, effective, patient-centered, timely, efficient and equitable.  As the American Academy of Pediatrics notes in this policy statement:

Because HDHPs require out-of-pocket payment in the initial stages of care, primary care and other outpatient services as well as elective procedures are the services most affected, whereas higher-cost services in the health care system, incurred after the deductible is met, are unaffected. HDHPs promote adverse selection because healthier and wealthier patients tend to opt out of conventional plans in favor of HDHPs. Because the ill pay more than the healthy under HDHPs, families with children with special health care needs bear an increased cost burden in this model. HDHPs discourage use of nonpreventive primary care and thus are at odds with most recommendations for improving the organization of health care, which focus on strengthening primary care.

Tuesday, April 29, 2014

Letting ideological purity stand in the way of common sense

Health care policy is rife with fads, unsupported and analytically flawed approaches to try to influence the way care is delivered with simple--but wrong--metrics used to determine unwarranted penalties.

There, I've said it.  But please don't put me as an ally of nay-saying doctors and hospitals who really don't want to improve the quality of care.  I've been devoting many years to advocating for patient-driven care, eliminating preventable harm, transparency of clinical outcomes, and front-line driven process improvement.

The problem is that poorly thought through interventions of government policy not only fail to improve care, but they raise levels of resentment and cynicism among the people we need to engage in making changes in the system.  Those interventions also have harmful unintended consequences.

The latest validation of the dangers of wrong-headed thinking is summarized in Robert Pear's article in the New York Times.  The lede:

Federal policies to reward high-quality health care are unfairly penalizing doctors and hospitals that treat large numbers of poor people, according to a new report commissioned by the Obama administration that recommends sweeping changes in payment policy.

More:

The panel found that existing payment policies unintentionally worsen disparities between rich and poor by shifting money away from doctors and hospitals that care for “disadvantaged patients.”

Measures of health care quality and performance — widely used by Medicare and private insurers in calculating financial rewards and penalties — should be adjusted for various “sociodemographic factors,” the expert panel said. The panel was created by the National Quality Forum, an influential nonprofit, nonpartisan organization that endorses health care standards.

“Factors far outside the control of a doctor or hospital — patients’ income, housing, education, even race — can significantly affect patient health, health care and providers’ performance scores,” said Dr. Christine K. Cassel, the president of the organization.

Sorry, but this isn't news.  Here's a related point noted by anyone who was paying attention three years ago: 

Karen E. Joynt and Ashish K. Jha from Brigham and Women's Hospital published an article in Circulation: Cardiovascular Quality and Outcomes, entitled, "Who Has Higher Readmission Rates for Heart Failure, and Why? Implications for Efforts to Improve Care Using Financial Incentives." Excerpts:

Among 905 764 discharges in our sample, patients discharged from public hospitals (27.9%) had higher readmission rates than nonprofit hospitals (25.7%, P<0.001), as did patients discharged from hospitals in counties with low median income (29.4%) compared with counties with high median income (25.7%, P<0.001). 

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.)

Look though, at the response of the Administration, as reported by Mr. Pear:

The Obama administration commissioned the study, but is not entirely comfortable with the recommendations, officials acknowledged. 

The Obama administration has championed the idea of pay for performance, with financial penalties for hospitals where deaths, readmissions or complications occur at rates above the national averages. The administration has said adjusting the data for social or demographic factors would be equivalent to accepting a double standard, with lower expectations for the care provided to low-income patients.

“We do not want to hold hospitals to different standards of care simply because they treat a large number of low-socioeconomic-status patients,” said Dr. Kate Goodrich, the director of quality measurement programs at the federal Centers for Medicare and Medicaid Services. “Our position has always been not to risk-adjust for socioeconomic status within our measures because of concern about masking disparities, and potentially rewarding providers who provide a lower level of care for minorities or poor patients.”

Sorry, but this is the response of a government that has let ideological purity stand in the way of common sense.  The issue is not about rewarding lower levels of care to poor patients.  It is about not penalizing hospitals that care for poor patients.

Monday, April 28, 2014

Sometimes, it really stinks

Doug Wojcieszak's passion is to get hospitals and doctors to see the value of apology and to have them make it part of their standard of care.  He often tells positive stories about places that have done this well, but every now and then he has a story that makes you cringe.

Here's the latest example of the latter. Lest you have a doubt about Doug's feelings, he titled it "Hospital’s PR Weasel Words After Tech’s Lies."  After I read the story, I felt that he might have been too kind in his choice of words.  An excerpt:
 
In summary, Perry Hospital technician Rachael Rapraeger lied about the results from over 1,200 mammograms.  In her plea deal with a criminal court, Ms. Rapraeger said she got behind in her work and created negative readings for over 1,200 mammograms….mammograms that were never reviewed by physicians.  Patients were lied to.  Ten patients actually had positive readings, and two have since died.   Ms. Rapraeger apologized for her conduct and was sentenced to six months in jail, 9.5 years of probation, a $12,500 fine, and is banned from the healthcare profession for 10 years.

Perry Hospital is currently facing 30 lawsuits from Ms. Rapraeger’s actions, and the hospital issued the following statement after her plea deal: “We are pleased this component of Ms. Rapraeger’s unfortunate action is concluded.”

Doug notes:

I am sure some PR person with the help of a gaggle of lawyers wordsmithed this doozy, and it really stinks.

Just right, Doug.  Thanks for your dedication to this cause.

Sunday, April 27, 2014

CLER progress?

The ACGME, the body that certifies US residency training programs, notes:

As a component of its next accreditation system, the ACGME has established the CLER program to assess the graduate medical education (GME) learning environment of each sponsoring institution and its participating sites. CLER emphasizes the responsibility of the sponsoring institution for the quality and safety of the environment for learning and patient care, a key dimension of the 2011 ACGME Common Program Requirements. The intent of CLER is “to generate national data on program and institutional attributes that have a salutary effect on quality and safety in settings where residents learn and on the quality of care rendered after graduation.”

One requirement of the program is supposed to include "opportunities for residents to report errors, unsafe conditions, and near misses, and to participate in inter-professional teams to promote and enhance safe care."

I've been looking for a "cler" presentation of the results of the site visits on this matter, but I can't find anything on the ACGME website or elsewhere.  According to this document, the ACGME has accredited 9516 programs in 2013-14, covering 121,778 full-time residents.  The page that indicates which programs are on probation (unfavorable status), shows the number to be 39, but it does not list the reasons.

Here are my questions. I know from personal visits and discussions with residents that many hospitals do not satisfy the requirement cited above. Have any of these programs been put on probation?  Whether on probation or not, will the names of hospitals that fail this test be made public?

If a patient-safety-oriented medical student applying for the residency match program wanted to know which hospitals do not satisfy this requirement, how could he or she find out?

Finally, I wonder if the CMS payments to hospitals for residency training should be based in some way on the extent to which core requirements and competencies are met, rather than the current fixed number of dollars per student?  (See the past part of this article by David Mayer on this topic.)

Friday, April 25, 2014

Women Leading

Last year around this time, I had the pleasure to tell you about a new book, The Orange Line, A Woman's Guide to Integrating Career, Family and Life, by Jodi Detjen, Michelle Waters, and Kelly Watson.  Now Jodi is offering a special three-day master class called "Women Leading" at Suffolk University on May 15-17 from 8:30AM to 4:30PM. Here's the description:

Take your career to the next level and become a key leader and influencer. This three-day course will teach you how to integrate your life and remove the self-imposed barriers that prevent success.
In small classes capped at 20, you’ll work in an intimate, team-building setting and develop lasting connections with your peers. 

As part of the course, you'll receive a copy of the book: The Orange Line™ - A Women’s Guide to Integrating Career, Family and Life, which was written by Professor Jodi Detjen. The book will help guide conversations about the work-life balance among women.

At the end of the course, you’ll have an over-the-phone coaching session in small groups. Professor Detjen will lead a discussion about achieving your goals, overcoming challenges, evaluating the 360 analysis, and adapting your plans for the future.

You’ll emerge from this course with a clearer understanding of yourself, including your leadership vision and values. You’ll learn how to negotiate, navigate difficult conversations, build lasting relationships, and much more.    

Register:            RSVP
Contact:             Mia Levitt, Program Manager, Center for Executive Education: mlevitt [at] suffolk [dot] edu

I want my money back

Like many people, I have been following the saga of the failed state health care exchanges, Massachusetts being one.  But a sentence in today's New York Times article about the Oregon exchange took my breath away:

Oregon has received $305 million in federal grants to build its exchange, according to the Congressional Research Service.

The Census Bureau reports the number of households in Oregon as 1.5 million. So we (yes, we) have spent about $300 per family to produce nothing.

As we look at that CRS report, we see that Massachusetts got $170 million for the same purpose and couldn't get its act together.  Hawaii, $205 million.  Maryland, $171 million.  And, in addition, according to the Pioneer Institute report, "Failure at the Connector will cost Massachusetts taxpayers over $100 million dollars this year" because 160,000 Massachusetts residents are on temporary public Medicaid coverage even though they don't qualify for MassHealth.

On Oregon, the Times reports:

[I]n February, the federal government delivered a devastating critique of the Oregon exchange, saying it had “no integrated project schedule” and no “overarching dedicated project manager” to keep work on track. Moreover, it said, the state did far too little to supervise its main information technology contractor, Oracle.

I strongly support the goals and purposes of the Accountable Care Act, but this level of managerial incompetence is breathtaking.  Shouldn't we as federal taxpayers ask for the failed states to return the US grants they received?  Perhaps, then, the states will have an incentive to recover the spent funds from the contractors they hired.

Thursday, April 24, 2014

Acetaminophen Caution and Guidance

We often take Tylenol pills or other acetominophen products (like some night time cold remedies) without thinking of them as drugs with possible harmful side effects.  An article in Medscape by Charles Argoff, entitled "Acetaminophen Caution and Guidance," reminds us to be careful. He says doctors should advise patients to read the labels of the prescription and over-the-counter medications so that they do not take multiple acetaminophen-containing products at the same time. Also, they should advise patients not to drink alcohol while taking acetaminophen-containing products. Excerpts:

Between 1998 and 2003, acetaminophen was the leading cause of acute liver failure in the United States, with 48% of these acetaminophen-related cases of liver failure being associated with accidental overdoses. Summarizing data from 3 different surveillance systems, there were an estimated 56,000 emergency department visits, 26,000 hospitalizations, and 458 deaths related to acetaminophen-associated overdoses per year from 1990 through 1998. A study from 22 medical centers in the United States that was completed in 2003 and was confirmed in a separate study in 2007, demonstrated that a high percentage of instances of liver injury due to acetaminophen were related to unintentional overdoses. In other words, the patient took too much by mistake.

On January 14, 2014, the FDA recommended that healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosing form. Even before that, in 2011 the FDA had asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet, capsule, or other dosing method by January 14, 2014.

In this particular directive, the FDA noted that severe liver injury with acetaminophen had occurred in patients who took more than the prescribed dose of an acetaminophen-containing product within a 24-hour period, took more than 1 acetaminophen-containing product at the same time, and/or who drank alcohol while taking acetaminophen products. While noting also that acetaminophen is widely used in many over-the-counter products, including over-the-counter cold products, the FDA directive did not provide any regulatory action regarding these particular products. The FDA did advise that many consumers are often unaware that many products contain acetaminophen, and, therefore, consumers could easily take too much by accident. But no actions were taken in regard to over-the-counter products.

Wednesday, April 23, 2014

GRACE: It all started by asking why, five times

Back in 2010, I reported on a protocol developed by Dr. Melissa Mattison and others called GRACE (Global Risk Assessment and Careplan for Elders). As noted then, this program was designed to improve the care of all hospitalized elders, with the hope of reducing the risk of delirium, falls, pressure ulcers, functional decline, etc.

But let's go back to the genesis of GRACE, when the staff wondered what might be the cause of many of the falls experienced by older patients.  As I noted in 2009:

Our review process often indicated that the staff had done just the right things with regard to fall prevention and supervision of patients. Using the "5 Why" process of Lean, they kept digging into the cause of these falls. A hypothesis emerged: Perhaps we were contributing to the likelihood of falls by over-medicating geriatric patients or missing important parts of their supervision and therefore causing them or allowing them to be disoriented.

The GRACE protocol was the result of this root cause analysis.  I'm now happy to provide a progress report, in the form of an article in the Journal of the American Geriatric Society. The program has been shown to make a difference.  Here are some excerpts.

Recognizing that older adults have specific care needs that are distinct from the needs of younger adults, a group of geriatricians, hospitalists, and nurses designed a supplemental checklist to accompany the standard bedside monitoring form.

Specifically, the bundle provides staff with a bedside checklist for individuals aged 80 and older admitted to the hospital and decision support in the CPOE system. The bedside check-
list prompts staff to screen for delirium and to implement delirium prevention and management strategies. The CPOE system provides decision support for antipsychotic and opioid analgesic ordering.


There were four main components of the intervention that were critical to its success. First, the intervention was targeted to a population likely to benefit from the intervention and that staff and the CPOE system are likely to identify easily. Units where individuals were already receiving specialized care plans (e.g., intensive care units, inpatient psychiatry) were excluded. Second, the decision support required for success of the intervention was carefully designed for this target population. Third, outcomes focused on critical intervention components were predetermined and monitored. Finally, throughout the intervention, educational curricula were created and offered to staff across clinical disciplines—including nursing, physician staff, and residents.

The findings indicate that the intervention improved prescribing of sedating medications—participants were significantly less likely to be prescribed haloperidol in excess of 0.5 mg or intravenous morphine in excess of 2 mg. There were more triggers for acute change in mental status, but this was seen in individuals receiving the intervention and in the concurrent controls. Significantly more individuals receiving the intervention were discharged to home than to ECFs [extended care facilities] than would have been expected, suggesting less in-hospital functional decline.

Tensions and Tempers on WIHI

Madge Kaplan writes:

The next WIHI broadcast — Transforming Tensions and Tempers on Health Care Teams — will take place on Thursday, April 24, from 2 to 3 PM ET, and I hope you'll tune in.
Our guests will include:
  • Neil Baker, Principal, Neil Baker Consulting and Coaching
  • Nan Cochran, MD, President, American Academy on Communication in Health Care (AACH); Director, On Doctoring
  • Calvin Chou, MD, PhD, FAACH, Professor of Clinical Medicine, UCSF; Vice President for External Education, AACH
Enroll Now

The last thing a patient needs to experience at a hospital or a clinic is tensions between staff members. Yet, we've all been there and seen and heard things that make us wonder “who isn’t getting along with whom” or, worse, are we getting the best care when we can tell providers are just barely disguising their frustrations with one another? It's a fair question, especially since health care is being redesigned at all levels to be more of a team effort. Doesn't that mean that the team has to be cohesive and everyone needs to get along?

We're going to get into this important issue on the April 24 WIHI: Transforming Tensions and Tempers on Health Care Teams. The topic couldn’t be timelier, and we’ve brought together an expert group that spoke to a packed room about managing conflict on health care teams at IHI’s National Forum in December.

Neil Baker is familiar to many of you as an IHI faculty member who’s spent the past 30 years helping organizations and professionals better deal with the “people issues” that can not only stall improvement work but also jeopardize patient safety. Nan Cochran wears a lot of hats, including being President of the American Academy on Communication in Healthcare. Dr. Cochran does a lot of training in conflict management and negotiation, which we’ll tap into on the April 24 WIHI.

Calvin Chou at UCSF rounds out our panel. His work focuses on teaching medical students and residents humanistic clinical skills that are critical to communicating more effectively with patients. Some of these same skills can help health care teams better appreciate their differences and avoid overreacting to one another, to the detriment of the team and patients.

What are you and your colleagues learning about building rapport and resolving tensions? I hope you’ll tune into the April 24 WIHI to share your experiences, learn from our experts, and bring members of your health care team with you. And, if you sometimes wonder what’s behind some of the difficult behaviors on teams, here’s some interesting additional reading. See you on April 24!
I hope you'll join us! You can enroll for the broadcast here.

The slippery slope between academia and pharma

I want to be very careful about how I present the following information, as I mean to suggest no improper or illegal behavior on the part of any individual.  Instead, consistent with my previous columns on these matters, I mean to suggest that it is a slippery slope when people in academic medical centers join the boards of directors of pharmaceutical companies. The issue is not their honesty or expertise.  The issue is that we lose the expertise of key people in helping us resolve thorny public policy debates.  A further issue is that, in serving two masters, they contribute to the erosion of public confidence in the research and clinical activities of the health care sector.

We start with a story by Andrew Pollack in the New York Times.  The lede:

Record sales of a new hepatitis C drug pushed the first-quarter earnings of Gilead Sciences far beyond expectations, the company reported on Tuesday, but could also heighten concerns about the high cost of the drug, known as Sovaldi, and the ability of the health care system to pay for it.

He explains:

The rapid uptake of Sovaldi to some degree reflects pent-up demand, as many patients were holding off treatment until it was approved in December. The drug, a pill taken once a day, has a higher cure rate, a shorter duration of treatment and fewer side effects than previous treatments.

But Sovaldi, which has a list price of $1,000 per pill, or $84,000 for a typical course of treatment, has become a flash point in a debate over drug prices.

Paying for Sovaldi for all the patients who need it could put financial strain on insurers, state Medicaid programs, the Department of Veterans Affairs and prison systems. UnitedHealth Group, one of the largest insurers, said last week that its first-quarter earnings had declined in part because it had spent more than $100 million on hepatitis C treatments, including Sovaldi, far more than it expected.

Some doctors say there is a benefit to treating even early stages of the disease, to prevent scarring of the liver.

“If cost were not a factor, we would want to treat the entire population,” said Dr. Rena Fox, a professor of medicine at the University of California, San Francisco. She said it was frustrating that “we finally get this great treatment and then we withhold it.”

Now, let's look at the membership of the Gilead Board of Directors.  It is not atypical in including luminaries from many fields, and among the group is Professor Richard Whitley, from the University of Alabama at Birmingham. His compensation from Gilead has been reported as $425,000.  A truly impressive physician, Dr. Whitley is:

Distinguished Professor of Pediatrics, Professor of Microbiology, Medicine and Neurosurgery; Loeb Eminent Scholar Chair in Pediatrics; Co-Director, Division of Pediatric Infectious Diseases; Vice-Chair, Department of Pediatrics; Senior Scientist, Department of Gene Therapy; Scientist, Cancer Research and Training Center; Faculty, Gene Therapy Center; Associate Director for Drug Discovery and Development and Senior Leader, Pediatric Oncology Program, Comprehensive Cancer Center; Director, UAB Center for Emerging Drug Discovery; Co-Founder and Co-Director, Alabama Drug Discovery Alliance. 

He is also "responsible for the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group whose role is to perform clinical trials of antiviral therapies directed against medically important viral diseases of children and adults including viruses considered as threats to human health." 

A more detailed description follows:

Through the NIAID-CASG we perform clinical trials of antiviral therapies directed against medically important viral diseases of children and adults. These include studies of neonatal herpes simplex virus infection, herpes simplex encephalitis, herpes zoster, enteroviral infections of the newborn, therapeutic interventions for congenital cytomegalovirus infections, hepatitis C, and respiratory virus diseases in the immunocompromised host. Work in these areas includes protocol design, assessment of efficacy and toxicity endpoints, application of contemporary clinical trial methodology and monitoring principals, and evaluation of biologic specimens obtained from volunteers in these studies.  [Emphasis added.]

According to this report, Dr. Whitley is an Editor of Antiviral Research, and is a member of the Editorial Boards of the Journal of Infectious Diseases, Sexually Transmitted Diseases, Reviews in Medical Virology, Antimicrobial Agents and Chemotherapy, Antiviral Chemistry and Chemotherapy, Infectious Diseases Watch for Pediatricians, Seminars in Pediatric Infectious Diseases, Gene Therapy, and Medscape Infectious Disease.

As we view all of this, we can only imagine the extent of Dr. Whitley's personal commitment to eradicating disease.  This is truly an outstanding record.  I'd bet, too, that he would strongly support expanded access to Sovaldi for humanitarian reasons.  But in all the searches I have done, I can find no public statements from him concerning the financial issue raised in Andrew Pollack's story.  Indeed, it would be very difficult for someone on the Gilead board to make a statement about such matters, as it would be viewed as inconsistent with the duty of loyalty and care required of corporate directors.

I note that Gilead has made the drug available at a dramatically lower cost in some other countries in the world.  As reported here,

The company’s reduced prices came after the World Health Organization worked with Gilead directly to help spread the drug's usage. So what determines who gets a discount and who doesn't? It's simple. Gilead admits their “global pricing model is based on a country’s ability to pay.”

As for the $1,000 a day American price for the extremely effective (and life-saving) medication, Gilead is holding firm that they “think the price is fair. It’s a one-time cost that is your lifetime cost.”

So, there we have the nub of the issue. An extremely respected scientist with Dr. Whitley's credentials could be among the most qualified in society to "referee" this kind of issue--to help us understand and balance the legitimate financial needs of the pharmaceutical industry with the equally important humanitarian concerns about a drug's availability and cost in America.  He cannot do so while on the board of the company producing the drug. The loss to society is that someone of Dr. Whitley's expertise and compassion is taken out of the public debate on these matters.

Beyond that, what does his silence on this issue say to the country about his duty to two masters, a federally subsidized drug research effort and a pharmaceutical company? What message does that send to the public about how they should view the relationships between academic medical centers and industry? I think it doesn't help either sector retain the public's confidence.
Distinguished Professor, Loeb Scholar Chair in Pediatrics, Professor of Pediatrics, Microbiology, Medicine, and Neurosurgery, University of Alabama at Birmingham - See more at: http://www.gilead.com/about/leadership/board-of-directors#sthash.f1uR5D5k.dpuf
Distinguished Professor, Loeb Scholar Chair in Pediatrics, Professor of Pediatrics, Microbiology, Medicine, and Neurosurgery, University of Alabama at Birmingham - See more at: http://www.gilead.com/about/leadership/board-of-directors#sthash.f1uR5D5k.dpuf
Distinguished Professor, Loeb Scholar Chair in Pediatrics, Professor of Pediatrics, Microbiology, Medicine, and Neurosurgery, University of Alabama at Birmingham - See more at: http://www.gilead.com/about/leadership/board-of-directors#sthash.f1uR5D5k.dpuf

Tuesday, April 22, 2014

Texting while "driving" in the OR

We all know we shouldn't text while driving, right? Because if you are going 30 miles per hour, your car has gone 44 feet for every second you are looking down at your iPhone. Bad things can happen even at that speed.  At 60mph, you go 88 feet per second.  Imagine how much damage you can do in that situation.  But remember the guy who said, "I only text on the highway"?

Well, now comes a new set of "drivers," doctors who text or otherwise use their electronic message devices while in the operating room. They are equally irresponsible.  Check out this article by Rebecca Buckwalter-Poza on Pacific*Standard. Excerpts:

In one ongoing malpractice case in Texas over the death of a 61-year-old woman following a low-risk cardiac procedure, attorneys for her family discovered that the anesthesiologist charged with administering anesthesia and monitoring the patient’s vital signs had been on his iPad throughout the operation. In his deposition, the surgeon testified that the anesthesiologist didn’t even notice the patient’s dangerously low blood-oxygen levels until “15 or 20 minutes” after she “turned blue.”

The anesthesiologist admitted to texting, accessing websites, and reading ebooks during procedures. He claimed, though, that “even when I’m doing so, I’m always listening to the pulse ox, always checking the blood pressure, always—you know, at least every five minutes.” It seemed lost on him that five minutes is an eternity in medicine: The brain begins to die after just a few minutes without oxygen.

While throughout the 1980s, most programs banned residents from so much as studying in operating rooms or on the ward, doctors now routinely do far more distracting things in these same settings, with no possible medical justification—from tweeting to texting to posting on Facebook.  

The term “distracted doctoring” doesn’t seem adequate to describe the phenomenon of health care providers who habitually use electronic devices for non-medical purposes during appointments and procedures. These doctors, nurses, and technicians aren’t momentarily distracted: They’re deciding to interact with Facebook friends or Twitter followers instead of the patient in front of them.

Perhaps hospitals should do what our local transit system does:  They prohibit even possession of cell phones by transit drivers while in buses and rapid transit vehicles.  Because if you have it, you will use it.

Monday, April 21, 2014

How to come to terms with wanton cruelty

A friend whose mother was murdered in Kabul, Afghanistan last month teaches us a lesson in how to come to terms with wanton cruelty.   If you feel inclined to support her family's non-profit organization in support of education and service opportunities for Afghan boys and girls, click here.

A small thank you to everyone who has made this month one surrounded with beauty and love. It is a quiet time, but there are miracles at every glance. I am ever more convinced that we need to embrace opportunities to be humbled – humbled by nature, by love, by those around us who understand the world differently. Perhaps in that humility we can find a way to all get along. Though I have refrained, for the most part, from reading the news reports, I do know that the attack in Kabul last month was carried out by boys who were not yet men. Had they met my mother in any other circumstance, they would have been met with kindness, and perhaps seen another way through this world. In light of this, and in gratitude to my loved ones who continue to share the beauty of this world with me, I make my peace today:

Oh, boys. You can’t have known
The silent mystery of the wind,
Tousling the hair of the childish grass
As if it had just made
A cheeky joke.
Or the laughter of the birds
Who were eavesdropping
The. Whole. Time.
But I will continue watching.

You can’t have heard
The endless waves of secrets
Held in every shell
Or the delighted squeals
Of a child bearing
Witness
To it all.
But I will continue to press my ear close
So I don’t miss a single heartbeat
This world has to offer.

You probably never knew
The grace of the sun
Caressing the caterpillar
Assuring it that
There will be light
When it is reborn.

You can’t have known
The giddy feeling of a first picnic
Or the electricity of holding hands
For the very first time
With one who will see you
Through everything.

You can’t have known
The hilarious struggle
Of a very pregnant woman
Trying to put on
Socks.

Oh boys.
You can’t have felt
The undeniable mercy
Of kneeling,
Touching your forehead
To Earth’s Lips
That the universe may tell you
Over and over and over again that
It loves you.
Yes, I am completely enthralled by
The Irresistible Beauty
Of this world.

And I will stay forever in that embrace
And love it back with all I have
And quietly pray that
Though you never knew it here
The peace is with you now.


Look, you can watch this happen in real time!

Those of you who had any doubt at all about the points I raised in my recent post about how the daVinci robot system has extracted funds from the health care system, check out this story by Jaimy Lee and Harris Meyer on Modern Healthcare, "Surgical Robot Costs put Small Hospitals in a Bind."  Excerpts:

Memorial Hospital of Converse County last year purchased a $2 million da Vinci Surgical System, the second hospital in Wyoming to do so. Memorial executives said they expect their facility to perform about 100 robotic surgeries a year. That's far below the estimated volume experts say is needed to produce a viable financial return within six years on the robotic system, whose average cost ranges from $1.5 million to $2 million.

Memorial, which reported an operating loss of $2.2 million in the first half of fiscal 2014, used cash reserves to buy the da Vinci system, manufactured by Sunnyvale, Calif.-based Intuitive Surgical. Memorial said 40% of its cost will be reimbursed by Medicare as a capital expense because it is a critical-access hospital.

Ryan Smith, the hospital's CEO, said he doesn't mind if it takes awhile for the pricey new piece of equipment to pay off because it's already attracting patients who previously would have traveled to other hospitals in Colorado or Utah to get robotic surgery. Also, it helps his hospital recruit and retain surgeons, and is expected to reduce surgical complications and lengths of stay. “We did not buy the da Vinci system to get a very high return on investment,” Smith said. “It was the right thing to do for our patients.”


While overall sales of da Vinci systems are on the decline, a number of small and rural hospitals are considering following in Memorial Hospital's footsteps, believing it will help them attract and retain surgeons and appeal to patients. The government system for financing critical-access hospitals helps underwrite some of the costs.

But small hospitals going down that path will face the same issues now confronting major systems that have installed surgical robots. Some studies have raised doubts about whether robotic surgery offers better outcomes than standard laparoscopic procedures. And Intuitive Surgical faces dozens of product liability lawsuits across the country filed by patients who claim injuries from the device. 


[By the way, notice how the hospital's website above, promises: "reducing outpatient recovery times, blood loss, and pain."  See my earlier post for documentation of how these claims are unsupported by the evidence.] 

For critical-access hospitals, Medicare helps subsidize the purchase as a capital expenditure on a depreciated basis, calculated by what percentage of patients are Medicare beneficiaries. But “it's a big question in terms of priorities and where your scarce resources are best used,” said Brock Slabach, senior vice president of the National Rural Health Association. “Patients perceive it to be better. But is the cost worth the benefit?”  

More small hospitals view the da Vinci system “as a tool they need to recruit and retain surgeons and to stay viable,” said Liz Tiernan, a consultant in the Advisory Board Co.'s research and insights groups. “It is considered a standard of care .… but it's rarely financially viable for them.”

[W]hen surgeons at a smaller hospital don't reach the estimated proficiency threshold, that raises questions about the adequacy of their experience. “It becomes even more difficult to justify this decision,” Tiernan said. 

Sunday, April 20, 2014

I, Robot has nothing on the truth

Here's the IMDb summary of the 2004 movie I, Robot:

In the year 2035 a techno-phobic cop investigates a crime that may have been perpetrated by a robot, which leads to a larger threat to humanity.

But we don't have to wait until 2035.  We've seen a different kind of "crime" perpetuated by a robot during the last decade or so.

If we could start all over again, would we want the medical community to spend billions of dollars in capital and operating costs on a medical device that had no proven relative efficacy compared to conventional, lower cost techniques?  I think most of us would say, "No."

But the medical community has been complicit in carrying out exactly this scenario with regard to the daVinci surgical robot.  The federal government has likewise stood by and watched, as have insurers.  At best, the establishment media has let the story go on for years, and, at worst, has been quick to jump on the bandwagon.  All to benefit the managers and shareholders of a private company.

What kind of money are we talking about?  How about 2,585 installations at a purchase price of about $1.5 million, or $3.9 billion?  And a required annual maintenance contract of about $150,000, for $387 million per year.  And disposable supplies used per surgery of about $2000, with about 100,000 cases per year, for a cost of $200 million.  (Or calculating another way, Intuitive Surgical, Inc. reported revenue of $2.3 billion in 2013, $2.2 billion in 2012, $1.8 billion in 2011.  Net income for those three years, by the way, totaled $1.8 billion.)

This has been a breathtaking saga.  We could hope that it would present lessons for the future, but there is no indication that it has done so, whether for the expanded use of this technology to other areas, or the introduction of other devices and procedures that comprise the medical arms race.

The most recent bit of evidence of the degree to which the country has been taken in is summarized in this article from Medpage Today:

Robot-assisted radical prostatectomy (RARP) led to complication rates, readmission rates, and rates of additional cancer therapy similar to those of conventional surgical prostatectomy, a review of almost 6,000 cases showed.

Patients who underwent RARP had significantly higher complications rates at 30 and 90 days, but blood loss and transfusion rates were lower, as was the risk of a prolonged hospital stay. After adjustment, the overall complication rates did not differ.

"RARP and open radical prostatectomy have comparable rates of complications and additional cancer therapies, even in the post-dissemination era," Quoc-Dien Trinh, MD, of Dana-Farber Cancer Institute in Boston, and co-authors concluded. "Although RARP was associated with lower risk of blood transfusions and a slightly shorter length of stay, these benefits do not translate to a decrease in expenditures."

But how about those supposed advantages with regard to urinary function and sexual function, i.e., quality of life issues?  Here was the result in a 2013 study in Urology:

Introduction of RALP (robot-assisted radical prostatectomy) did not result in improvement of functional outcome. There was no difference regarding urologic function/bother score or sexual function/bother score at 36-month follow-up in patients treated with LRP or RALP.

But this is not a new story. Look at this article from Urology in 2008:

Radical prostatectomy is an effective form of therapy for patients with clinically significant prostate cancer; however, outcomes are highly sensitive to variations in surgical technique. Because of the risks of perioperative complications and urinary and sexual dysfunction, which appear to be as great with robotic-assisted prostatectomy as with any other technique, patients with low-risk cancer, especially those >60 years, might be attracted to more conservative alternatives, including active surveillance, radiotherapy, and focal ablation.

Another article in Urology in 2011 talked about the learning curve associated with this "intuitive" system.  It suggests that a man might want to ask just how many procedures his surgeon has, er, under his belt:

Despite the intuitive nature of the daVinci system a definite learning curve with RALP (robotic-assisted laparoscopic prostatectomy) exists in relation to console time and LOS. Over 50 cases need to be completed to effect an appreciable improvement in learning curve. Positive surgical margin rates did not improve, suggesting that this may have a longer learning curve.

Had people been alert to this 2007 article in Urology, they could have seen that, in addition to the patient perspective, there is an institutional one, too, associated with the cost of learning curve for this equipment:

The literature search involved 8 series, with a range of learning curves from 13 to 200 cases. The least expensive learning curve was $49,613 and the most expensive learning curve was $554,694. The average learning curve was 77 cases and cost $217,034.

Conclusion

Costs associated with operative time while learning RAP (robotic-assisted prostatectomy) are substantial, and should be considered when deciding whether to implement RAP at an individual institution.

A 2008 article presented the business case as follows:

Purchase of a robot reduces income by at least $415,000 per year, due to the cost of the device and the service contract. Donation of a robot lessens the financial impact by $300,000 per year. If an institution maintains an identical caseload when switching from LRP to RAP, then it cannot maintain equivalent profits.. This holds true even if the robot is donated.

To maintain profits, an increase in caseload is needed to cover the added costs of the robot. At all levels of baseline productivity, purchase of a robot requires a greater case volume to maintain profits, relative to donation of a robot. Centers that perform a high volume of LRP at baseline need to only make small increases in total case volume to maintain profit, while centers with low volumes at baseline need to make very large changes in operative volume to cover the additional costs of robotics.

Like an airline making money with an airplane, the robot will only pay for itself if it is used at a high volume.

Imagine what kind of financial pressure that puts on doctors and hospitals to recommend prostate surgery rather than more conservative treatment approaches. How many men have had surgery who did not need to because of those pressures? How many of those have suffered irreparable harm?

Friday, April 18, 2014

Congratulations to Willy Spaan

I met Willy Spaan many years ago, during a visit to my former hospital. Later, he invited me to his hospital, Jeroen Bosch Ziekenhuis in the Netherlands, to conduct a number of seminars and workshops on quality and safety and other process improvement.  I'm very pleased to pass along, now, this announcement:

Prof. dr. W. Spaan, Chairman of the Management Board of the Jeroen Bosch Hospital, has been elected Care Manager of the year 2014. The jury awarded the title to Spaan because he is the most innovative and inspiring, and implemented patient safety into every layer of the organization. W. Spaan is someone who doesn’t have to be in the spotlights. He encourages the employees and medical specialists and provides them with the freedom to successfully do their work.

The election was organized by the magazine Zorgvisie, and is annually awarded to the most successful care manager of the year. The other two nominees were Jan Kimpen, CEO of University Medical Centre Utrecht, and Jeroen van den Oever of Fundis, formerly Vierstroom, in Gouda.

Quality

As chairman, Spaan has made quality into the guiding principle of care. He has tirelessly worked to create an active and open patient safety culture at the Jeroen Bosch Hospital (JHA). The existing internal and external openness about mortality rates, the quality indicators and disasters have greatly contributed to the internal awareness that it is important to keep improving, and that patients have confidence in organizations that are built on a strong culture of improvement.

 A personal encounter in 2008 with Donald Berwick, the former CEO of the Institute of Health Improvement, the leading institute in the field of quality and safety in health care, inspired him to implement the six dimensions of quality (Safety, Patient-centered, Effectiveness, Efficiency, Timely and Equality) as a corporate strategy in our hospital. From that moment, Spaan started to focus on quality in the care we provide to our patients. This has also led to JHA belonging to the five best hospitals in the Netherlands with regards to care indicators. 

The Jeroen Bosch Hospital is very proud that Spaan is elected as care manager of the year. His nomination is a great opportunity to further promote his mission for quality and safety, and to continue inspiring others. 

All candidates are assessed on the sustainable and innovative results they have achieved in the health care organization they lead. Their ideas about the organization of care inspire others inside and outside their institution, and they are an example for care managers in the Netherlands. The three candidates were nominated by a selection committee consisting of Professor Pauline Meurs and organization consultant Hanke Lange.  The winners were announced at the end of the congress  Focus on proper care in Haarlem.  Jury President André Rouvoet, also chairman of Insurers Netherlands, announced the winners.

Shelter in Place

One year later:  A few days after last year's Boston Marathon bombing, while the police and others were searching for the remaining suspect, the Governor asked people to "shelter in place," to stay at home and avoid being on the streets.

A sign of the cooperation received is this traffic map of the Boston metropolitan area on that day.  All routes are shown as green, i.e., no traffic at all!

But some people found it difficult to stay inside on a beautiful spring day.  These two young folks escaped for an exercise routine in the field behind my house!



Thursday, April 17, 2014

Berwick DID like the UK system after all

In a remarkable show of disinterest by the mainstream media in Massachusetts, it appears that only the Associated Press cared enough about Don Berwick's proposal for a single payer plan to give it the attention of a reporter. Here's the story:

BOSTON (AP) — Democratic candidate for governor Don Berwick on Wednesday called for a ‘‘single health care payment system’’ for Massachusetts.

Berwick, who headed the federal Centers for Medicare and Medicaid Services for 17 months, is one of five Democrats, two Republicans and three independent candidates seeking the state’s chief executive post.

Speaking at Boston University School of Medicine, he praised President Barack Obama’s health care law and the 2006 Massachusetts law that inspired it, adding that Massachusetts can again lead the nation.

But, he said, the state and country can do better by essentially expanding Medicare, which covers the elderly, to include all residents regardless of age.

‘‘We can create and manage a simplified, transparent, efficient, and fully accountable single health care payment system in Massachusetts and we can make it work for the people,’’ Berwick said in a prepared copy of the speech.

That ‘‘single-payer’’ option has long been a dream of liberal Democrats, but has also been considered a political impossibility in a divided Congress.

It was Berwick’s praise for aspects of the British single-payer health care system that marked him for criticism from congressional Republicans, who said it showed his affinity for big government programs. They blocked his confirmation as Obama’s permanent head of the Centers for Medicare and Medicaid Services after his temporary appointment.

Berwick on Wednesday brushed off the criticism of those he called ‘‘naysayers’’ and said a single-payer system would have less ‘‘waste, confusion, complexity, and opacity’’ than the current system, which he said forces patients and doctors to spend time and money sorting out varying coding systems and billing rules.

By contrast, he said, Medicare spends just 1 percent on overhead.

It is ironic that the case made by lots of Republicans against Don for the CMS job was, in fact, based in part on his position on this issue.  Back then, recall, "Republicans . . . seized on remarks he made praising Britain’s National Health Service as an 'example' for the United States to follow." Of course, the Republicans dramatically overstated the issue and would have found any reason to be against him, but time has shown it to be the case that Don actually does support an NHS-like single payer system.

Now, the question is whether this issue will resonate in Massachusetts.

Acts of leadership and courage can be powerful forces for social change

Two lovely articles crossed my desk, and I'd like to share them with you.

The first is by Peter Pronovost, called "The ripple effect." Excerpts:

Cornell University sociologists Milena Tsvetkova and Michael Macy explained how we are much more likely to perform a kind act when we experience or witness one. Experiencing a small kindness is more potent than observing on.

There is a large segment of health care workers who want to do the right thing, to do things differently, but are held back for a variety of reasons. Sometimes they just want to know that there are others who are willing to move forward with them. Someone needs to takes that first step, to set off the chain reaction. Others want to know that if they lead, others will follow.

Take, as a great example, Janet Wall, a support associate on the Weinberg ICU at The Johns Hopkins Hospital. Wall has worked on the unit for 14 years and often jokes that she is “protecting her house” when she sees a behavior that is not consistent with the values that the unit is built around. If she sees anyone neglect to perform hand hygiene before entering a patient room—be it a world-renowned surgeon or a clerical worker—she will immediately remind them to do so. She’s on the unit to save lives, she proudly announces.

Anyone who has worked in health care or been a patient knows how uncomfortable it can be to ask someone else to wash their hands. But Wall took the risk to do something different and hold others accountable. And once she did, other support associates and staff began to follow. Many staff who had never before taken those kinds of risks began to speak up. This social movement has spread around the unit, and even nurses who before did not feel empowered to speak up are doing just that.

Acts of leadership and courage can be powerful forces for social change when they are aligned towards a goal. And as Wall demonstrates, you don’t need a C-suite title to set these in motion. So start a social movement in your unit or clinic. Take that first step—an uncommon act of kindness, generosity or courage. Witness or experience these acts, and then pay it forward, and watch as the world around you begins to change.

And then the next is from Tracy Granzyk at MedStar Health, called "Teamwork and Thinking Differently: Can Healthcare Leaders Do This?" Viewing a terrific instrumental quartet, she observes:

A piano has 88 keys, yet new music is created every day. How can we take what we have to work with in healthcare and see what has yet to be discovered or apply what has yet to be tried — especially when it comes to teamwork.

Wednesday, April 16, 2014

Meanwhile, south of the Massachusetts border

Just when I thought that Massachusetts health care environment was complicated, along comes this story from ConvergenceRI.  Richard Asinof is a tireless reporter who documents the health care comings and goings in the state.  We could use someone of his energy and depth in Massachusetts, someone who connects current events with what has happened in the past--with a healthy dose of similes and an appreciation for irony.

Look at these excerpts, for example:

Like new spring growth in the briar patch, thorny consequences of Prime Healthcare’s takeover of Landmark Medical Center have begun to emerge, less than four months after the deal was finalized that allowed the California-based, for-profit hospital system to purchase the financially troubled nonprofit community hospital.

UnitedHealthcare Insurance Company and UnitedHealthcare of New England have asked the R.I. Department of Health to remove Landmark from its network of hospitals, along with 52 physicians, 32 of which are primary care providers, who have “admitting privileges exclusively” at the hospital. 


The only commercial insurer with an ongoing participating agreement with Landmark is Blue Cross & Blue Shield of Rhode Island – a legal arrangement that was part of the final purchase deal.   

There is a certain amount of irony in the current situation, given the events of two years ago, when in the summer of 2012, it was Blue Cross & Blue Shield of Rhode Island that had requested to remove Landmark from its network of hospitals during its contract negotiations with Steward and Landmark, leading to an aggressive advertising campaign attacking Blue Cross by Steward and Landmark and a lawsuit against Blue Cross by the special master that was later withdrawn.

Failed mediation efforts with Blue Cross involving Rhode Island Attorney General Peter Kilmartin [and leaked confidential letters between Kilmartin and Steward Health Care CEO Dr. Ralph de la Torre] led in part to the breakdown of the proposed purchase of Landmark by Steward, a for-profit hospital system based in Boston and owned by a private equity firm, Cerberus, in New York City.

Amazing. Miraculous. Groundbreaking. Incredible.

Gary Schwitzer from HealthNewsReview.org makes this point on Twitter:

A journalist must work hard to fit “amazing, miraculous, groundbreaking, incredible” into 1 robotic surgery story.

He is referring to this piece on TheSpec.com. Although the entire story is worth reading, I especially like this approach to the scientific method:

The new donation will support the funding of surgeries but also launch a more complete program where patients' results can be tracked. It's hoped those results can be used to promote broader use of robotic surgery and secure more funding, said Dr. Waël Hanna.

It's clear we don't have to wait for the results of those studies!

Three days to help Alex go back in time

Our buddy Alex Green has made good progress on his IndieGoGo project to step back in time and engage in old-fashioned typesetting.  Three days are left, and he's 91% percent of the way there.  Please help bring back a bit of the past. Contribute here.

Tuesday, April 15, 2014

Berwick proposes Medicare for all in Massachusetts

Massachusetts gubernatorial candidate Don Berwick is holding a press conference on Wednesday, April 16, at 7pm at Bakst Auditorium at Boston University's School of Medicine to present his plan called "Medicare for All," a single payer system for the state.  Many will be curious to see what he proposes.

As one of Don's supporters in the Democratic primary race, I don't necessarily agree with all he says, but I love that he stretches the limits in his public policy proposals.  It keeps the race vibrant and gets people engaged.

There is a delicious irony to Don's single payer approach in this state, in that a large argument for it has been provided by the state's largest insurer, Blue Cross Blue Shield--which would be put out of business by the proposal.  Why?  Well, BCBS has been so intent on expanding the use of global payments that it has effectively shifted actuarial risk from itself to the providers who have adopted that payment regime.  One can logically ask the question: "If insurance companies don't bear risk, why do we need insurance companies?"  If all they do is handle transactions and claims, who needs them as plan administrators?  What core competencies do they bring to bear that any well-run financial services organization does not?

I'm being slightly facetious but not a lot.  The state's insurers continue to collect a similar percentage of the premium dollar each year for administrative functions.  They seem unable to realize economies and improvements in that part of their business.  Thus, as premiums have risen, their share has risen proportionately. Indeed, one can argue that they have an incentive for higher premiums and more claims processing.  Hmm, it sounds like they operate under their own fee-for-service reimbursement approach, something they decry as inappropriate for the rest of the industry!

Poke that sleeping lion, Don, and we'll see whether it responds with a roar or a meow!