The story of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group case refuses to go away, even if it still has not created any echoes in the mainstream media or the medical and health care literature. Now it appears that the NQF has an even bigger conflict of interest problem than previously reported.
As of our last post on 5 February, 2014, the background was-
- 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
- In retrospect, people who worked with Dr Denham on various health care quality and patient safety projects acknowledged they should have realized something fishy was going on.
- Senator Charles Grassley is now investigating
The Conflicts of the NQF CEO
In our first post about the case, I noted that at the time that Dr Denham was a committee member, the NQF seemed to have a relatively weak policy on conflicts of interest, although this post noted it was later strengthened somewhat. I also commented that the organization seemed accommodating of conflicts of interest affecting its board of directors, and to have institutional conflicts of interest in that it accepted funding from health care corporations which might have interests in NQF quality standards being written in their favor.
So maybe it should not be too great a surprise that the latest twist in this case is the revelation that the new CEO of NQF has her own quite significant conflicts of interest. Last week, ProPublica published a story about the conflicts of interest of the new CEO of the NQF. The basics were:
The top executive at the country’s pre-eminent health care quality organization is being paid hundreds of thousands of dollars by two large medical companies that have a stake in the group’s work.
The payments to Dr. Christine Cassel raise new conflict-of-interest concerns at the National Quality Forum, which endorses benchmarks that Medicare uses to compensate hospitals based on performance.
As ProPublica recently reported, the Quality Forum is reviewing its conflict-of-interest policies after being stung by allegations that the former co-chair of one of its endorsement committees had accepted kickbacks to help a drugmaker win favorable treatment.
Cassel received about $235,000 in compensation and stock last year as a board member for Premier Inc., a North Carolina company that says it provides group purchasing and performance improvement consulting for an alliance of 2,900 hospitals and thousands of nursing facilities and other providers.
Cassel also was paid $189,000 as a board member for the Kaiser Foundation Health Plans and Hospitals in 2012, Quality Forum officials confirmed to ProPublica. Kaiser’s tax forms are not available for 2013, but they show that in 2010 and 2011 Cassel received a total of $357,125.
Cassel, who declined to be interviewed, took over as chief executive officer last summer after a decade as president and CEO of the American Board of Internal Medicine.
Not unexpectedly, the official position of the NQF was nothing to see here, just move along.
The group's chairwoman, Helen Darling, said in an email that the board was 'fully aware' of Cassel’s outside compensation when she was hired in December 2012. Darling, president of the National Business Group on Health, initially agreed to an interview but did not respond to follow-up contacts.
Spokeswoman Ann Greiner said the board got a legal opinion and discussed it in depth before agreeing that Cassel could recuse herself 'where her outside board service would be construed as an actual or perceived conflict of interest.' So far that hasn’t happened, Greiner said.
Note that those defending NQF saw no reason to explain why it had not previously disclosed Dr Cassel's other positions or how the conflicts would be managed. Perhaps a board that includes executives of large health corporations, of a financial firm with large health care interests, and of a trade associations for large health care corporations would not see a problem with having a CEO who is simultaneously on the boards of a for-profit hospital group purchasing organization and a very large, albeit non-profit health care system.
Others were much more skeptical and critical.
Two ethics experts interviewed by ProPublica said Cassel’s relationships with Kaiser and Premier present obvious conflicts given the Quality Forum’s broad involvement in health care.
The Quality Forum maintains a clearinghouse of more than 700 quality measures — covering everything from tracking hospital readmissions to setting information technology standards — that are established by expert committees and widely adopted by U.S. hospitals and other providers.
The ethics experts said they were uncertain how Cassel could recuse herself to anything related to Kaiser and Premier and still do her job.
'Would that mean every time somebody said the word ‘hospital’ she would have to say, ‘I can’t be in this conversation?’' said Eric Campbell, a Harvard School of Medicine professor who has published extensively on conflicts of interest.
'Conflict of interest is as much an appearance as it is an effect,' added Sheldon Krimsky, a medical ethics expert at Tufts University. He called Cassel’s conflicts 'absolutely egregious'
Campbell and Krimsky said the cleanest way to eliminate potential conflicts would be for Cassel to resign from the outside boards.
The plot thickens because of the amount of influence wielded by the NQF,
In 2009, Medicare awarded a $40 million contract to the Quality Forum to recommend measuresit could adopt. President Obama’s health care reform law accelerated the move to pay-for-performance. Medicare already has begun penalizing and rewarding hospitals based on readmission rates, mortality and patient satisfaction measures. By 2017, it’s expected that 9 percent of Medicare payments will be based on performance.
Having some leverage on that influence would seem to be particularly important to Premier Inc, the now publicly held for-profit group purchasing organization on whose board Dr Cassel sits,
Premier reported revenues of $869 million in the fiscal year ending last June. It spent more than $1 million on lobbying in 2013, according to OpenSecrets.org. In August and November, the company urged members of Congress to instruct Medicare to run any quality measures through the Quality Forum.
Premier featured Cassel’s status as a board member and future top executive of the Quality Forum in documents last May describing its initial public stock offering. In September Cassel acquired 3,704 shares of Premier stock that were then worth about $100,000.
The company’s business involves group purchasing and a consulting arm that uses data analysis to help providers perform better on various quality metrics. In October, a measure sponsored by Premier to track hospital care by the average length of stay was up for renewal by the Quality Forum.
Of course, a Premier Inc spokesperson denied that could be a problem,
[Spokesperson Blair] Childs said Cassel’s role on the Premier board doesn’t pose any conflict of interest, and that her relationship with Premier was vetted carefully by the Quality Forum’s board. Cassel was a good addition to the Premier board because of her commitment to improved care and lower costs, he said.However, I submit that the conflict here is particularly acute because Dr Cassel is not merely a part time consultant or adviser to Premier Inc. She is on the board of directors. In 2006 we first discussed a newly discovered species of conflict of interest in health care, in which leaders of medical or health care organizations were simultaneously serving on boards of directors of health care corporations. We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive. It ostensibly requires board members to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management. However, in any case, the stated or actual interests of a member of the board of a health care corporation, like a for-profit hospital purchasing organization, could be very different and at odds with the mission of an academic medical institution or a non-profit ostensibly dedicated to improving health care quality.
However, in my humble opinion, the issue here goes even beyond a blatant and undisclosed conflict of interest. That a top steward of a big for-profit health care corporation could simultaneously be the top leader of an influential non-profit health care quality improvement organization suggests that increasingly US health care is run by an insular group of insiders whose influence gets ever larger because of their collective power, not necessarily because of their dedication or ability to improving health care. As ProPublica put it,
Rosemary Gibson, an author and senior adviser to The Hastings Center, a research group dedicated to bioethics in the public interest, said she wasn’t surprised at Cassel’s outside compensation. So much money permeates decision-making in Washington, she said, that participants have become oblivious.Additional Questions
'The insiders don’t see it,' Gibson said. 'It’s like a fish in water.'
Finally, the forced disclosure of Dr Cassel's conflicts of interest raise some additional questions.
Did Dr Cassel Have an Equally Severe Conflict as CEO of the ABIM?
Dr Cassel was previously the CEO of the American Board of Internal Medicine (ABIM). This non-profit organization also has a very substantial influence on health care. Physicians must pass its examinations to become certified as internal medicine specialists or sub-specialists such as cardiologists, gastroenterologists , etc. Recently certified physicians, and soon all certified physicians will have to participate in ABIM sanctioned "maintenance of certification" activities or risk being flagged as not adequately keeping with the board's concept of medical progress.
Thus the content of the ABIM examinations and sponsored activities can influence physicians' thinking and decision making. How the ABIM under Dr Cassel's leadership dealt with conflicts of interest affecting those who write examinations, provide content, and lead the organization is unclear.
Furthermore, it seems possible that Dr Cassel had a conflict of interest generated by her work for Premier Inc while she was still CEO of ABIM. However, before Premier Inc made its initial public offering, information about its management and governance was scarce. Whether Dr Cassel was on the board of a precursor to the publicly traded Premier Inc is not easy to ascertain. Maybe the current ABIM leadership needs to consider whether Dr Cassel had a conflict involving Premier Inc or its precursor while she was CEO of ABIM, and how that conflict could have affected the direction of ABIM at the time.
How Would Dr Cassel Respond to Criticisms of Premier Inc and How Would that Reflect on the ABIM and the NQF?
Premier Inc is a hospital group purchasing organizations (GPOs). GPOs, particularly including Premier Inc, have been criticized for anti-competitive practices that distort the market in health care drugs and devices, for accepting the ethical equivalent of kickbacks, and particularly for generating drug shortages. For example, an opinion piece in the Baltimore Sun claimed,
The main reason is that most of these drugs are purchased through a handful of supply chain middlemen called hospital group purchasing organizations, or GPOs, whose anti competitive practices and self-dealing have been documented in Senate antitrust hearings, media reports, government investigations and lawsuits. These buyers' monopolies purchase upward of $300 billion in drugs, devices and supplies annually for about 5,000 private acute care hospitals, including virtually every one in Maryland. Five giants account for roughly 90 percent of all such purchases. [Apparently including Premier Inc - Ed]
Under a 'pay-to-play' arrangement, vendors compete not on the basis of who can supply the best product at the best price but on who can pay the biggest fees to these cartels. In return, they receive exclusive contracts. This artificially constrained supply chain is why many drug manufacturers have fled the marketplace, leaving just one or two to produce many drugs. In turn, hospitals receive incentives based on their compliance with contracts the GPOs award to favored suppliers.
In 1987, Congress enacted the Medicare anti-kickback 'safe harbor,' which exempted GPOs from criminal penalties for accepting payments from suppliers — payments that in virtually every other industry would be considered unlawful kickbacks.
The GPOs trade organization vigorously contested this argument, of course.
But the awkward fact is that Dr Cassel, as a board member of Premier Inc, can be seen as a steward of that corporation, and hence responsible for the its overall direction. Thus, Dr Cassel could easily find herself in the uncomfortable situation of having to defend and justify questionable behavior by Premier Inc while simultaneously wearing the hat of CEO of NQF. How that would play out is not obvious.
So now it appears that the problems with conflicts of interest at the NQF affect not only its standard setting committees, board of trustees, and organizational funding. They also affect its CEO.
Dr Joe Collier said, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." [Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.] To reduce further unclear thinking and its consequences, we again urge that academic medical institutions, and non-profit organizations dedicated to improving patient care and public health forthwith begin real reductions of conflicts of interest affecting all those who make clinical or policy decisions.
We previously suggested:that NQF leaders might also consider:
- further strengthening their conflict of interest policy for standard setting committees, particularly by minimizing the number of committee members with conflicts, and banning individuals with conflicts from chairing committees, as per the IOM report on standards for trustworthy clinical practice guideline development
- increasing transparency about conflicts of interest, particularly by making disclosures for all projects available without complex web searching
- decreasing institutional conflicts of interest by refusing funding from health care corporations whose revenues might be affected by the content of standards and guidelines, and reducing conflicts affecting NQF board members and executives
I would now add that in my humble opinion, the NQF ought to immediately fully disclose any other conflicts that might exist affecting its committees, staff, board of trustees, or funding, and then begin a progressive but ultimately complete phase out of all significant conflicts affecting these areas.
Roy M. Poses MD for Health Care Renewal