St. Jude Medical Settles

We could not let more than a week go by without discussing another legal settlement by a major health care organization.  From the Pioneer Press,

Little Canada-based St. Jude Medical will pay $3.7 million to resolve allegations the medical device company provided kickbacks to hospitals in Kentucky and Ohio to secure sales of heart devices, the U.S. Department of Justice announced Friday.

The government alleged that St. Jude Medical provided rebates that were retroactive and paid based on a hospital's previous purchases of heart device equipment from the company. Prosecutors also charged that St. Jude Medical paid rebates for purchases of heart-device equipment sold by its competitors to induce purchases of similar equipment from St. Jude Medical in the future.

As I understand it, the issue was that the rebates did not amount to a simple volume discount, but were given only if the hospital allowed St. Jude to become its dominant supplier of certain devices, for example,

One such rebate was offered to Parma Community General Hospital in Parma, Ohio, a suburb of Cleveland, according to settlement papers made available by the government on Friday. The medical center could earn discounts on products if it gave St. Jude Medical 90 percent of its annual usage of mechanical heart valves, 80 percent of its annual usage of conventional pacemakers and 50 percent of its annual usage of conventional implantable defibrillators, according to the settlement agreement.

The two-year contract began in April 2003 and St. Jude Medical at the time did not have government approval to sell newer 'biventricular' pacemakers and ICDs. A rival company, however, did have approval for such products, and the settlement agreement asserts that St. Jude agreed to give the Ohio hospital a rebate for each biventricular pacemaker and ICD purchased from the competitor so long as Parma hospital maintained market share targets on St. Jude Medical products.

'The contract also mandated that once (St. Jude Medical) gained Food and Drug Administration approval for its own biventricular devices, the rebates would end, and (Parma) could earn discounts by giving (St. Jude Medical) 80 percent of its annual usage of biventricular pacemakers, and 50 percent of its annual usage of biventricular ICDs,' the settlement agreement states.

What was the problem with this?

'Hospitals should base their purchasing decisions on what is in the best interests of their patients,' Tony West, assistant attorney general for the Justice Department's civil division, said in a statement.

St. Jude's response was that it was all so trivial and so long ago,

In a statement issued Friday, St. Jude Medical said: 'The allegations centered on small, isolated product rebates that the company paid more than five years ago. The company entered into a settlement agreement in order to avoid the potential costs and risks associated with litigation.'

So add another marcher in the parade of legal settlements. While most of the marchers in this parade seem to be pharmaceutical companies, it appears that device manufacturers are trying to catch up.

We have been noting new entrants to this parade for a while mainly as a way to document how often health care organizations, including some of the largest and seemingly most respectable organizations, have been accused of unethical conduct.  Often this conduct seems likely to increase health care costs, by driving up the prices of goods or services, or by encouraging the use of expensive tests or treatments when perhaps something simpler and cheaper would be just as good for the patient.  Sometimes, this conduct seems likely to decrease health care quality, and worsen patient outcomes because the tests or treatments being pushed by the unethical behavior may be less effective, and/or more likely to cause harm than other credible alternatives.

We also have repeatedly said that the usual sorts of legal settlements we have described do not seem to be an effective way to deter future unethical behavior.  Even large fines (and the one described above would be peanuts to a large health care corporation) can be regarded just as a cost of doing business.   Furthermore, the fine's impact may be diffused over the whole company, and ultimately comes out of the pockets of stockholders, employees, and customers alike. It provides no negative incentives for those who authorized, directed, or implemented the behavior in question. My refrain has been: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Fermented Grain Recipes from Around the World

In my last two posts on grains, I described how traditional food processing methods make grains more nutritious and digestible (1, 2). I promised to briefly describe a few recipes from around the world, then got distracted by other things. Here they are.

Africa: Ogi

Grain fermentation is widespread in Africa and is probably nearly as old as agriculture on the continent. The nutritional importance of fermentation is suggested by the amount of time and effort that many African cultures put into it, when they could save themselves a lot of trouble by simply soaking and cooking their grains.

Ogi is a common West African porridge that's eaten as a staple food by people of all ages. It's even used as a weaning food. It's made in essentially the same manner from corn, sorghum or millet.

Whole grain is soaked in water for one to three days. It's then wet milled, mixed with water and sieved to remove a portion of the bran. Extra bran is fed to animals, while the white, starchy sediment is fermented for two to three days. This is then cooked into a thin or thick porridge and eaten.

South America: Pozol

At first glance, some people may think I left the 'e' off the word 'pozole', a traditional Mexican stew. However, pozol is an entirely different beast, an ancient food almost totally unknown in the US, but which fueled the Mayan empire and remains a staple food in Southeastern Mexico.

To make pozol, first the corn must be 'nixtamalized': whole kernels are boiled in a large volume of water with calcium hydroxide (10% w/v). This is a processing step in most traditional South American corn recipes, as it allows a person to avoid pellagra (niacin deficiency)! The loosened bran is removed from the kernels by hand.

The kernels are then ground into dough, formed into balls and placed into banana leaves to ferment for one to 14 days. Following fermentation, pozol is diluted in water and consumed raw.

Europe: Sourdough Bread

Sourdough bread is Europe's quintessential fermented grain food. Before purified yeast strains came into widespread use in the 20th century, all bread would have been some form of sourdough.

Although in my opinion wheat is problematic for many people, sourdough fermentation renders it more nutritious and better tolerated by those with gluten/wheat sensitivity. In an interesting series of studies, Dr. Marco Gobbetti's group, among others, has shown that fermentation partially degrades gluten, explaining the ability of fermentation to decrease the adverse effects of gluten in those who are sensitive to it (3). They even showed that people with celiac disease can safely eat wheat bread that has been long-fermented with selected bacteria and yeasts under laboratory conditions (4). Rye contains about half the gluten of bread wheat, and is generally nutritionally superior to wheat, so sourdough rye is a better choice in my opinion.

To make sourdough bread, first the dry grains are ground into flour. Next, the flour is sifted through a screen to remove a portion of the bran. The earliest bread eaters probably didn't do this, although there is evidence of the wealthy eating sifted flour in societies as old as ancient Egypt and ancient Rome. I don't know what the optimum amount of bran to include in flour is, but it's not zero. I would be inclined to keep at least half of it, recognizing that the bran is disproportionately rich in nutrients.

Next, a portion of flour is mixed with water and a "sourdough starter", until it has a runny consistency. The starter is a diverse culture of bacteria and yeast that is carefully maintained by the bread maker. This culture acidifies the batter and produces carbon dioxide gas. The mixture is allowed to ferment for 8-12 hours. Finally, flour and salt are added to the batter and formed into dough balls. These are allowed to ferment and rise for a few hours, then baked.

My Experience

I've tried making ogi (millet) and pozol, and I have to admit that neither attempt was successful. Pozol in particular may depend on local populations of bacteria and yeast, as the grains' microorganisms are killed during processing. However, I do eat fermented grains regularly in the form of homemade brown rice 'uthappam' and sourdough buckwheat 'crepes'. The buckwheat crepes are tasty and easy to make. I'll post a recipe at some point.

The first two recipes are from the FAO publication Fermented Cereals: a Global Perspective (5).

Fermented Grain Recipes from Around the World

In my last two posts on grains, I described how traditional food processing methods make grains more nutritious and digestible (1, 2). I promised to briefly describe a few recipes from around the world, then got distracted by other things. Here they are.

Africa: Ogi

Grain fermentation is widespread in Africa and is probably nearly as old as agriculture on the continent. The nutritional importance of fermentation is suggested by the amount of time and effort that many African cultures put into it, when they could save themselves a lot of trouble by simply soaking and cooking their grains.

Ogi is a common West African porridge that's eaten as a staple food by people of all ages. It's even used as a weaning food. It's made in essentially the same manner from corn, sorghum or millet.

Whole grain is soaked in water for one to three days. It's then wet milled, mixed with water and sieved to remove a portion of the bran. Extra bran is fed to animals, while the white, starchy sediment is fermented for two to three days. This is then cooked into a thin or thick porridge and eaten.

South America: Pozol

At first glance, some people may think I left the 'e' off the word 'pozole', a traditional Mexican stew. However, pozol is an entirely different beast, an ancient food almost totally unknown in the US, but which fueled the Mayan empire and remains a staple food in Southeastern Mexico.

To make pozol, first the corn must be 'nixtamalized': whole kernels are boiled in a large volume of water with calcium hydroxide (10% w/v). This is a processing step in most traditional South American corn recipes, as it allows a person to avoid pellagra (niacin deficiency)! The loosened bran is removed from the kernels by hand.

The kernels are then ground into dough, formed into balls and placed into banana leaves to ferment for one to 14 days. Following fermentation, pozol is diluted in water and consumed raw.

Europe: Sourdough Bread

Sourdough bread is Europe's quintessential fermented grain food. Before purified yeast strains came into widespread use in the 20th century, all bread would have been some form of sourdough.

Although in my opinion wheat is problematic for many people, sourdough fermentation renders it more nutritious and better tolerated by those with gluten/wheat sensitivity. In an interesting series of studies, Dr. Marco Gobbetti's group, among others, has shown that fermentation partially degrades gluten, explaining the ability of fermentation to decrease the adverse effects of gluten in those who are sensitive to it (3). They even showed that people with celiac disease can safely eat wheat bread that has been long-fermented with selected bacteria and yeasts under laboratory conditions (4). Rye contains about half the gluten of bread wheat, and is generally nutritionally superior to wheat, so sourdough rye is a better choice in my opinion.

To make sourdough bread, first the dry grains are ground into flour. Next, the flour is sifted through a screen to remove a portion of the bran. The earliest bread eaters probably didn't do this, although there is evidence of the wealthy eating sifted flour in societies as old as ancient Egypt and ancient Rome. I don't know what the optimum amount of bran to include in flour is, but it's not zero. I would be inclined to keep at least half of it, recognizing that the bran is disproportionately rich in nutrients.

Next, a portion of flour is mixed with water and a "sourdough starter", until it has a runny consistency. The starter is a diverse culture of bacteria and yeast that is carefully maintained by the bread maker. This culture acidifies the batter and produces carbon dioxide gas. The mixture is allowed to ferment for 8-12 hours. Finally, flour and salt are added to the batter and formed into dough balls. These are allowed to ferment and rise for a few hours, then baked.

My Experience

I've tried making ogi (millet) and pozol, and I have to admit that neither attempt was successful. Pozol in particular may depend on local populations of bacteria and yeast, as the grains' microorganisms are killed during processing. However, I do eat fermented grains regularly in the form of homemade brown rice 'uthappam' and sourdough buckwheat 'crepes'. The buckwheat crepes are tasty and easy to make. I'll post a recipe at some point.

The first two recipes are from the FAO publication Fermented Cereals: a Global Perspective (5).

Before we revolutionize medicine via spending hundreds of billions on IT, perhaps we should first fix this problem

Before we revolutionize medicine via spending hundreds of billions on IT, maybe we should first fix a far more tractable problem.

From Health Beat and Maggie Mahar:

A New Survey Reveals What Most Hospitals Patients Don’t Know About the Residents Who Care For Them-- Part 1

Summary: Most hospital patients have no idea that the resident treating them could be coming to the end of a 30-hour shift. If he is exhausted, the resident’s judgment may be impaired. Yesterday, the union that represents some 13,000 residents and interns nationwide (CIRSEIU), the American Medical Student Association (AMSA) Public Citizen, the consumer advocacy organization based in Washington DC, , as well as sleep scientists at the Harvard Medical School’s Division of Sleep, announced the results of survey published in BMC Medicine, revealing how little the public knows about residents’ hours.

Sleep deprivation is likely to lead to errors; residents themselves acknowledge that lack of sleep has caused them to make mistakes that harm, and sometimes even kill patients. Exhaustion also affects how they feel about their patients.In 2008, the Institute of Medicine (IOM) recommended capping shifts at 16 hours, saying that longer shifts are unsafe for patients and residents themselves. The Accreditation Council on Graduate Medical Education (ACGME), the group that oversees the training of physicians in the U.S currently allows resident physicians to work for 30 consecutive hours up to twice per week. The ACGME has been reviewing the IOM recommendations and is expected to announce its decision later this month.

The problem: residents represent cheap labor. Some say that the ACGME faces an inherent conflict of interest because its board is dominated by the trade associations for hospitals, doctors and medical schools that benefit from the residents’ long hours.

Read the entire post at the link above.

There are fundamental social flaws in healthcare for which IT is most definitely not the solution. However, some of those hundreds of billions of dollars earmarked for IT might be better spent on additional clinical staff, so Residents can get a decent night's sleep.

-- SS

RUC Off - the New England Journal Once Again Fails to Mention the Unmentionable

Last week, the influential New England Journal of Medicine published an article by Bruce Vladek entitled "Fixing Medicare's Physician Payment System."(1)  Although only identified as working for Nexara, a health consulting business, Mr Vladek was a former administrator of what was then called the Health Care Financing Administration (HCFA) of the US Department of Health and Human Services (DHHS), the part of the department that then ran the US Medicare program.  Vladek thus can reasonably be viewed as an expert on Medicare. 

Vladek identified two main problems with the current way physicians are paid by Medicare.  First,

Medicare is captive to an arbitrary, if elegantly conceived, formula for total payments to physicians — the sustainable growth rate (SGR). In the alternate reality of the Congressional budget process, the SGR will reduce Medicare's physician payments, which already trail those from private insurers, as far into the future as the eye can see.

Second,

there is widespread consensus that the relative fees in the current system are a significant cause of the growing imbalance in supply and utilization between primary care and specialty services in the U.S. health care system. That imbalance, in turn, is widely perceived as a major cause of both excessive costs and inadequate quality of care. This is not just a Medicare problem: the Medicare Resource-Based Relative Value Scale is used by most private insurers to set relative prices for physicians.

Vladek expanded on the second point as follows

the basic mechanics of the Medicare Physician Fee Schedule, which was supposed to change physician payment to increase rewards for primary care services at the expense of procedural and interventional services, appears to have gone totally off track. For various reasons, the fee schedule, which originally did increase the prices of evaluation and management services relative to those of surgery or invasive procedures, turned in the other direction through the process of annual updating of relative value units. Surgeons, radiologists, and some medical specialists are now paid two to three times as much per hour as providers of cognitive services, which is about where we began 20 years ago; this was the situation that the fee schedule was supposed to fix.

The question of the relative virtues of primary versus specialty care can be debated ad nauseam, but in other wealthy countries that serve their populations at least as well as we do, the ratio of primary care physicians to specialists is much higher than in the United States, and the gap in compensation is much smaller or the poles even reversed. Young physicians, burdened by increasing educational debts, may well choose a career path on the basis of a major difference in compensation, especially when the better-compensated positions require less ongoing responsibility for patients and offer better working hours.

This is about all that Vladek wrote about how the imbalance between how Medicare pays for primary care and other "cognitive services," and for procedures came about. Vladek, and many others have argued that this imbalance has lead to strong financial incentives that have been slowly destroying primary care, and strong incentives that have lead to the use of too many procedures, both strong drivers of rising costs in the most expensive health care system in the world.

Vladek noted vaguely that "through various reasons," the incentives were imbalanced by "the process of annual updating of relative value units."

However, as we have discussed in several blog posts, a lot more is known about how this process got "totally off track."

In fact, in 2007, an article by Bodenheimer et al in the Annals of Internal Medicine explained the problems in considerably more detail.(2)  As we wrote then, Its main points included

• Proceduralists are often able to learn how to do their procedures more quickly, and thus increase the volume of procedures done, while office and hospital visits can only be sped up so much.
• The process used to update the RBRVS system is biased towards procedures for three main reasons: 1. "specialty society influence in proposing RVU [relative value unit] increases," 2. the specialist-heavy RUC [Relative Value Scale Update Committee] membership," and 3. "the desire of RUC specialists to avoid increases in evaluation and management [that is, cognitive, or non-procedural] RVUs."
• Medicare now uses a formula to limit increases in overall spending. The use of this formula leads to across the board cuts in all reimbursements. Since cognitive services reimbursements were never high to begin with, and have rarely been individually increased, these cuts tend to have disproportionate decreases.
• Private insurers and managed care organizations tend to follow Medicare's lead in their reimbursement procedures, but tend to tilt the playing field even more in favor of procedures versus cognitive services. Several studies showed that such payers paid more for procedures than did Medicare, but about the same for office and hospital visits.

The role of the RBRVS Update Committee (RUC) is complex and in many ways mysterious.  As we wrote before, to update the system, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee. The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are opaque, and the proceedings of the group are secret.

To expand on the penultimate point, the current page on the AMA web-site that describes the RUC only lists its members in terms of their specialties and organizational affiliation.  Their names do not appear.  A response to a previous post by me on the subject by the then Chair and Chair-Elect of the RUC suggested that the RUC membership is not quite secret. They stated that "a list of the individual members of the RUC is published in the AMA publication, Medicare RBRVS 2009: The Physicians Guide." This publication is available from the AMA here for a mere $71.95. However, the book is not on the web, or in my local or university library, and I have no other way to easily access it.  Thus, the RUC membership as at best relatively opaque.

To expand on the ultimate point, as Goodson(3) noted, RUC "meetings are closed to outside observers except by invitation of the chair." Furthermore, he stated, "proceedings are proprietary and therefore not publicly available for review."

The fog surrounding the operations of the RUC seems to have affected many who write about.  We have posted (here, here, and here) about how previous publications about problems with incentives provided to physicians seemed to have avoided even mentioning the RUC.  In 2010, post the US recent attempt at health care reform, the RUC seems to remain the great unmentionable.  Even the leading US medical journal seems reluctant to even print its name. 

Thus, as we noted before, however, the mysteries about it remain:

• How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
• Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC?
• How did the RUC become de facto in charge of this process?
• Why does the AMA keep the membership on the RUC so opaque, and give no input into the RUC process to its general membership?
• Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
• Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?

Without discussing how the incentives for physicians became so unbalanced, do we really expect we can fix them?  In this case, the persistence of the anechoic effect seems to be doing real damage to the discussion of the critical issues we in the US face today.
References


1. Vladek B. Fixing Medicare's physician payment system. N Engl J Med 2010; 362:1955-1957. (Link here.)
2. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (Link here.)
3. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310.  (Link here.)