The Implications of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group Case Continue to Grow, but Remain Anechoic

The story about CareFusion, Dr Charles Denham, and the National Quality Forum certainly has legs, but continues to tread very softly. 

Background

At the time of our last post, on January 28, 2014, the basics were:
-  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice
 -  The CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative and other health care skin cleaning
-  The Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
-  The implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
-  The draft of the standard to prevent surgical site infection written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision
-  The Department of Justice alleged that the standard was based on a journal article sponsored by Cardinal Health, from which CareFusion split, and which may have been manipulated by its sponsor
-  NQF leaders asserted that after hearing of the case from the DOJ, the organization severed ties with Dr Denham and the non-profit organization he runs,  established a policy not to accept money from funding organizations whose leaders are on its committees, reviewed all the standards set by the committee of which Dr Denham was co-chair, and twice revised its conflict of interest policy.
- Despite these efforts by the NQF to remove excess influence by Dr Denham, a specific recommendation to use ChloraPrep, specified by formula but not by name, did appear in another NQF standard, one for preventing central line infections; the NQF logo apparently appeared on at least one educational event run by Dr Denham that advocated the use of ChloraPrep; and CareFusion cited NQF support in at least one promotional brochure

Dr Denham's Previous Associates Now Have Doubts

According to an article in Health Leaders Media, Dr Denham was associated not only with the NQF, but also another well known organization that promotes patient safety, the Leapfrog Group.  Since the CareFusion settlement was made public, this association has come to an end:

Denham was appointed to Leapfrog's Safe Practices Committee as Chairman in 2006. 'The position represented a voluntary commitment with no financial or contractual relationship between Dr. Denham and Leapfrog,' says a Leapfrog statement.

On Wednesday, Denham resigned his position from the committee 'to make sure the present distraction does not impact you or the work you do.' The group accepted his resignation on Thursday.

Leapfrog's president and CEO, Leah Binder, said in an interview with HealthLeaders Media: 'We've never taken any money from him and we have no contracts with him.'

Leapfrog has asked Denham and his company, TMIT, to 'remove any language from its website implying Leapfrog endorsement of 'test beds,' as this is not authorized. Further have TMIT remove any reference to a Leapfrog Hospital Survey 'flight simulator,' as this authorization was only given in 2006 and expired in 2007.'

On Thursday, Binder issued a statement saying her board 'was concerned with Dr. Denham's failure to reveal to the National Quality Forum or Leapfrog his potentially compromising relationship with CareFusion, which demonstrated a lack of transparency inconsistent with our organization's core values and mission.'

Note that the Leapfrog group charged that Dr Denham failed to disclose his financial relationships with CareFusion to them.  The article also implied that Dr Denham was falsely claiming that the Leapfrog Group had endorsed various activities by his Texas Medical Institute of Technology.  So it appears that Dr Denham's efforts to conceal his conflict of interest - and that is likely an understatement of his relationship with CareFusion -  and to make it appear that prestigious patient safety organizations supported CareFusion products were more widespread than we initially realized. 

Furthermore, a post by Dr Robert Wachter on his blog Wachter's World noted 

In retrospect – always in retrospect – it should have been obvious that, when it came to Dr. Charles Denham, something was not quite right.

He admitted that many aspects of the National Quality Forum's and his relationship with Dr Denham were in retrospect questionable.  These included the obscurity of the sources of the lavish resources that Dr Denham's organizations commanded and the wealth that Dr Denham displayed.

 A colleague visited him at his home in Laguna Niguel, an affluent beachfront LA suburb, and reported that it was palatial – not something commonly acquired on the salary of a former radiation oncologist. About five years ago, trying not to be too obvious, I asked Chuck where his money came from. He mentioned something about his wife’s family, and that he had decided to leave clinical practice to commit his life to patient safety. On several occasions, he talked about his 'research test bed,' saying, 'We’re in more than half the hospitals in America.' It wasn’t entirely clear what this meant; having visited many hospitals over the years, I never heard of one that was using the services of TMIT, the way you hear about hospitals that work with Premier or the Advisory Board or the Governance Institute. Very little of this added up,...

Another concern in retrospect was how Dr Denham became editor of a journal on patient safety:

The Journal of Patient Safety launched early in the safety field, co-sponsored by the National Patient Safety Foundation. To me, JPS has never been very good or particularly influential, and by all accounts it struggled to make ends meet. Then in 2011, I learned that it had named a new editor. You guessed it: Denham. The change had been made so precipitously that the NPSF, a founding sponsor, claimed it had been blindsided and removed its sponsorship in protest. I looked back to see whether Denham’s pedigree could justify his being named the editor of an academic journal. A PubMed search revealed that, before 2009, he had not had a single first-author publication in a 20-year career. Since then he has had 12, 11 of them in JPS.

Finally, Dr Wachter recounted that many of his professional colleagues ended up involved with Dr Denham, often with doubts, but doubts upon which they did not act,

Over the past few years, I received at least five different calls from colleagues who had been approached by Chuck to work on one project or another – a video to improve radiology safety, an effort to reduce central line infections, and several others I can’t recall. In each case, the question posed by my colleagues was a version of, 'Is this guy for real?'  In each case I said the same thing: Yes, both he and the situation seem odd, and no, I don’t know where he gets his money. Yet he appeared to be a nice guy, good to his word, and he produced results. I told them that – despite my head scratching – I couldn’t think of a sound reason not to work with him. When I mentioned this yesterday to Peter Pronovost, the Johns Hopkins intensivist who is the world’s leading safety researcher, he told me, 'It’s not that five people didn’t understand Chuck… I don’t know anyone who did understand.'

Again, it appears that Dr Denham's deceptions may have been considerably larger than indicated by the initial reports.

Senator Grassley Now Has Questions

The redoubtable Senator (R - Iowa), who is known to be particularly vigilant about conflicts of interest in health care, has now officially stepped in.  According to an article in ProPublica, 

An influential senator is demanding copies of contracts and conflict-of-interest policies from the National Quality Forum after allegations that kickbacks were paid to influence its patient safety guidelines.

Sen. Charles Grassley cited 'serious concerns' about how the Quality Forum vets its expert advisers and suggested the group may have endorsed a drug for a use the government hasn’t approved. 

The NQF is in this hot seat because it gets extensive US government support,

In 2012, three-fourths of the Quality Forum’s $26 million in income came from the government to endorse health care quality measures and evaluate spending. It’s expected to receive about $10 million from the federal government this year under provisions of the Affordable Care Act. 

The group promised a swift reply,

Spokeswoman Ann Greiner said the Quality Forum will promptly reply to Grassley. The group already had announced a new, 30-day review of its guidelines and policies after ProPublica raised questions about ChloraPrep last month.

'As you know, we fully cooperated with the DOJ inquiry, and have our own review of NQF processes (including conflict of interest policies) related to the 2010 Safe Practices report under way,' Greiner said in an email, referring to the group’s latest patient safety guidelines.

More Questions about How Dr Denham May Have Tried to Influence the NQF to Promote ChloraPrep

The latest article by Joe Carlson for Modern Healthcare raised a question about how Dr Denham knew the results of the New England Journal of Medicine article at the time he alluded to its findings at an NQF meeting,

The NQF committee's discussion of the study took place in August 2009 (PDF), and the results of the clinical trial comparing alcohol-chlorhexidine versus traditional iodine-based surgical antiseptics didn't appear in print in the New England journal until January 2010. Journals typically prohibit release of data in peer-reviewed studies before publication.

The article also underscored a question raised by Senator Grassley

Grassley contends that CareFusion didn't even have Food and Drug Administration approval for that specific indication of ChloraPrep at the time the NQF was talking about it.

'It is concerning that a prominent expert at NQF was encouraging non-approved uses during a review of patient safety best practices while being paid millions of dollars by the manufacturer of ChloraPrep,' Grassley wrote in a letter Monday (PDF) to NQF President and CEO Dr. Christine Cassel.

The list of questions about possibly deceptive practices by Dr Denham that could have promoted his pay-master CareFusion's products continues to grow, as does the scope of the apparent influence of his actions.  While this case includes many elements familiar to Health Care Renewal readers, such individual and institutional conflicts of interest, kickbacks and other aspects of health care corruption, manipulation of clinical studies, questionable clinical practice guidelines, and deceptive marketing practices, the scope of the case is becoming extraordinary.  It now involves at least two respected non-profit organizations that promote health care safety and quality, two medical journals, many respected medical academics, and an undetermined number of hospitals. 

Summary - Where are the Echoes?


It is heartening that leaders of the NQF have responded to this case openly, and without some of the defensiveness we have often seen when questions are raised about the actions of important health care organizations.  It is also heartening that at least one US Senator has taken an interest.  Yet despite its  scope and the potential importance of these reactions to it, this case has remained relatively anechoic.

We have often, but not so much lately, discussed the anechoic effect.  Cases, issues and ideas that might raise questions about the powers that be in health care, or might offend or threaten those who profit the most from the our dysfunctional health care system often have few echoes in the mainstream media and the medical, health care and health policy literature. 

While the CareFusion/ Dr Denham/ National Quality Forum/ Leapfrog Group case seems like it ought to be very important, and many writers have now addressed it, so far it has only been covered by relatively obscure outlets.  Although initial brief coverage of the CareFusion settlement appeared in business news services like Reuters, all coverage since has been in Modern Healthcare, ProPublica, Health Leaders Media, and several blogs, including Health Care Renewal. Presumably this is the reason another blogger, in the WBUR CommonHealth blog, wrote ironically,

Paging Dr. Atul Gawande, paging Dr. Atul Gawande. Please call your assigning editor at The New Yorker to discuss the scandal around the $11 million that the company CareFusion allegedly paid to a leading figure in the patient safety field who pushed the company’s surgical antiseptic.

I confess, that’s just my fantasy, that Dr. Gawande — prominent himself in patient safety as author of 'The Checklist Manifesto' — might want to take on this assignment. 

 

So it appears the anechoic effect is still with us. When leaders of big health care organizations enjoy ever increasing pay and influence, and the organizations they lead become ever more dominant, the risk of causing them offense continues to grow.  So it is all to easy to choose to ignore what might trouble the new health care plutocracy. But if no one notices the emperor has no clothes, he will continue to march around naked. 

by Roy M Poses MD for Health Care Renewal

Which Frogs A-Leaping?

Reported so far mainly in medical news outlets, e.g., in WebMD health news, was a survey from the Leapfrog Group naming the US best hospitals. There has also been some local coverage in areas in which some of the named hospitals are based, e.g., here in the Star-Telegram.

The Leapfrog Group proclaims itself to be "a voluntary program aimed at mobilizing employer purchasing power to alert America’s health industry that big leaps in health care safety, quality and customer value will be recognized and rewarded." It is usually described as a group of large employers out to improve health care.

Is that description accurate? Who are its members.? The most recent list is here.

On it are some well known large companies, such as Boeing and IBM. But what is most striking about its membership is the prevalence of health care corporations. A full 14 of 49 members (28.6%) are health care corporations. These include pharmaceutical companies, e.g.,

• Boehringer Ingelheim,
• Eli Lilly and
• Sanofi-Aventis.

These also include health care insurers and managed care organizations, e.g.,

• Aetna Inc,
• Blue Shield of California,
• HCA,
• UnitedHealth, and
• Wellpoint.

These include hospitals and hospital networks, e.g.,

• Greenville Hospital System, and
• Heartland Surgical Specialty Hospital.

And these include other health care companies, e.g.

• Milliman (purveyors of care guidelines), and
• Thomson Healthcare (providers of health care information resources).

The members also include companies who, while not being purely in health care, have significant health care businesses, such as General Electric.

One would expect that companies who make money by providing health care goods and services may have different ideas about health care costs and quality than companies who do not do any health care related business.

So it seems that it is the truth that the Leapfrog Group is an organization of employers, it is not the whole relevant truth. In fact, it appears that the Group includes significant representation of companies who have vested interests in health care being done in certain ways. Thus, its ideas about how to improve quality and lower costs may have been influenced by the vested interests of its members, which may not represent just the interests of employers who provide health insurance to their employees. At least, the organization should make clear that it includes "employers" who also sell drugs, sell health insurance, manage care, and market health care information.

This seems like another example, in a somewhat different dimension, of conflicts of interest in health care, and of the failure of such conflicts to be clearly disclosed. This also seems like another demonstration that things are rarely what they seem in the complex and not always honest world of health care, particularly in the US.

In my humble opinion, full disclosure of all relevant conflicts in all dimensions, and consideration of whether certain kinds of conflicts should be not merely disclosed, but reduced or eliminated, might go a long way to improving our problems with health care costs, quality, and access.

"Sunlight is the best disinfectant."

Note, see our previous post here about a previous version of Leapfrog Group membership.

ADDENDUM (19 September, 2007) - On the Running a Hospital Blog, Paul Levy posted a bit more positively about Leapfrog, although he finished somewhat ambiguously by wondering whether the group has "lost importance" by hopping "over their own approach."

The WSJ Health Blog provided more detail about the LeapFrog hospital quality report here.

Leapfrog Over What?

In the US, large employers have become more vocal about the need to control the cost of their employees' health care, for which they pay, and improve its quality. Leading the charge on this one has been the Leapfrog Group, which announces itself as "an initiative driven by organizations that buy health care who are working to initiate breakthrough improvements in the safety, quality and affordability of healthcare for Americans." The Group proclaims that "today, doctors and hospitals are paid without regard to the quality or affordability of the care they provide. This practice discourages efforts to deliver better and more efficient care. Leapfrog and our members are working to create real incentives to improve care through new payment practices. We also encourage consumers to choose high quality health care providers."

In a 2005 article in Health Affairs written by Robert S Galvin (director of corporate health care at General Electric), and Suzanne Delbanco (CEO of the Leapfrog Group), the authors proclaimed, "large employers can play a unique role in theU.S. health care system, using private-sector purchasing approaches to procure health benefits for their employees. Most employers believe that the appropriate use of market forces, such as public disclosure of physician and hospital performance measures, incentives to create price- and quality-sensitive consumers, and rewards for better care, is the optimal way to control costs and improve quality." So, " in 2000 a small group of large employers formed the Leapfrog Group to address these shortcomings in the market. They developed purchasing principles to deliver a new message to health plans and providers about the imperative of swift action to "leapfrog" over the current state of poor value."

The Leapfrog Group describes its members thus "Leapfrog has over 170 members who are made up of Fortune 500 companies and other large private and public organizations that provide health benefits for their employees, retirees and dependents. Together they spend nearly $67 billion each year on health care for 36 million Americans in all 50 states." Perusual of the Leapfrog Group's membership list does include some prominent, large corporations that employ many people, for example, Citigroup Inc, and Qwest Communications International Inc.

(It also includes many health care related companies, including pharmaceutical companies like AstraZeneca, Eli Lilly, GlaxoSmithKline, Merck and Co, and Schering-Plough, and managed care companies, like Aetna Inc, Cigna, HCA, Humana, and UnitedHealthGroup, just to name a few, which may have particular interests in quality and affordability issues beyond those entailed by their status as large employers who pay for their employees' health insurance. But that is for another day.)

Thus a recent article in the Wall Street Journal (available here from the Pittsburgh Post-Gazette) adds some irony for this Friday. The article is about how "former top executives at many corporations are receiving partial or full lifetime medical coverage on top of pensions valued at millions of dollars." Furthermore, "companies often provide their top executives with more generous health-care plans than other full-time employees get and then continue to provide the richer benefits through retirement." Most of these benefits are not clearly disclosed by the companies' public filings. Two relevant examples:

• "Citigroup Inc. promised to pay the premiums and out-of-pocket expenses for both health and dental care for Chairman Sanford I. Weill and his wife now, and it will continue to provide those benefits for the rest of the Weills' lives, the company's proxy statement says. Citigroup will also continue to pay for any taxes Mr. Weill owes on the imputed income arising from these benefits. A company spokeswoman says the benefit dates back to a 1980s contract and isn't available to other executives."
• "Regular employees who lose their jobs can apply for continued health-care coverage under Cobra, the federally mandated requirement that employers of a certain size allow departed employees to remain in the company health plan for some 18 months. However, the coverage, which can cost more than $1,000 a month, can be too expensive for laid-off workers." However, "Qwest Communications International Inc., pay[s] 100 percent of executives' Cobra costs, according to filings. A Qwest spokesman confirms those details but declines to comment."

Not to be too heavy-handed, but as mentioned above, Citigroup Inc, and Qwest Communications International Inc are both members in good standing of the Leapfrog Group. It looks like some large employers' concerns about controlling the costs of health care do not apply to their top employees. Top executives of such corporations may be well insulated from the sorts of concerns about health care that affect their employees. Yet it is the top executives, not the employees, who are represented in such organizations as the Leapfrog Group. Any changes that the Leapfrog Group manages to make in the provision of health care to their employees are not likely going to affect these top executives. So what is it, again, that the Leapfrog Group wants to leap over?
But as F Scott Fitzgerald said, "the very rich are different from you and me."