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Mylan Settles, Merck KGaA Pays the Fine

The<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements"> parade of legal settlements</a> involving large health care organizations accused of wrong-doing just gets more and more crowded.  Here is the latest, <a href="http://www.pittsburghlive.com/x/pittsburghtrib/news/breaking/s_714910.html#">courtesy</a> the Pittsburgh Tribune-Review: <blockquote>Mylan Inc., a generic-drug manufacturer in Cecil, agreed to a $280 million settlement of allegations that its Dey Inc. specialty-drug subsidiary cheated the government out of millions of dollars by reporting falsely inflated payments for several drugs, the Justice Department said. 'The government paid millions of claims for far greater amounts than it would have if Dey had reported truthful prices,' the Justice Department said. Mylan acquired Dey when it purchased Merck KGaA's generic-drug business in October 2007 for $6.8 billion. The government's action began before Mylan acquired Dey. Dey said in a statement that Merck KGaA is responsible for paying the full amount of this settlement as well as all costs and other expenses associated with pending and future related Medicare and Medicaid reimbursement lawsuits involving Dey.</blockquote> It all gets so tiresome, doesn't it. However, before one starts yawning, remember how such settlements are markers of the prevalence of bad behavior by major health care organizations. The continuing <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of settlements</a> thus is a big clue that there is something very rotten going on in health care, that the leadership of health care is increasingly amoral, greedy, and lawless. Here again is our generic statement on the phenomenon:  As in many previous cases, note that the monetary cost of the above settlement, while it seems large to normal humans, would be just slightly more than round-up error for a large multi-national company.  As I have said repeatedly,  penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue.  As long as the bad behavior continues, expect health care costs to continue to rise, while access falls, and quality suffers.  True health care reform requires accountability, integrity, and transparency of health care organizational leadership.

Mylan Settles, Merck KGaA Pays the Fine

The parade of legal settlements involving large health care organizations accused of wrong-doing just gets more and more crowded. Here is...

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Exactech Settles, Its Regional Sales Director Pleads Guilty

The march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by health care organizations continues.  Here is a curious story in two parts.  The first part was <a href="http://www.gainesville.com/article/20101207/ARTICLES/101209597/1109/sports?Title=Exactech-must-pay-3-million-to-avoid-prosecution">reported</a> in the most detail by the Gainesville (FL) Sun: <blockquote>Gainesville-based Exactech must pay $3 million and submit to a year of federal monitoring under a settlement to avoid prosecution on charges that resulted from an investigation into whether orthopedic implant manufacturers were paying kickbacks to surgeons to use their products. The company announced the deferred prosecution agreement Tuesday after three years of an expanded federal probe. The U.S. Attorney's Office for the District of New Jersey agrees not to prosecute charges of conspiracy to violate federal anti-kickback laws if the company avoids any violations for a year. </blockquote> What did Exactech do to wind up in this pickle? It is not really clear. The article noted: <blockquote>What the U.S. Attorney calls kickbacks Exactech calls consulting fees to surgeons to help develop better products — a common practice in the medical product field.</blockquote> One can get a little better idea of what was going on by seeing what changes the company agreed to make: <blockquote>Exactech will continue using surgeons as consultants, but under a more rigorous process that verifies that the work is needed, tracks the surgeons' work and pays them fairly.</blockquote> The article went out of its way to say: <blockquote>In accepting the agreement, Exactech does not admit to any wrongdoing and the U.S. Attorney acknowledges that the company's conduct did not hurt patient health or patient care.</blockquote> Meanwhile, however, a short <a href="http://www.dailyrecord.com/article/20101208/UPDATES01/101208051/Chester-NJ-salesman-pleads-guilty-to-violations-of-US-kickback-laws">article</a> appeared in the Parsipanny (NJ) Daily Record: <blockquote>A salesman from Chester pleaded guilty to conspiring to violate a federal anti-kickback statute by entering into illegal financial deals to get surgeons to use his company's products, the US Attorney's Office said Tuesday. Douglass Donofrio, 45, director of sales for Exactech Inc.'s northeast region, entered his guilty plea Tuesday before District Judge Garrett E. Brown in Trenton. Exactech, a publicly traded, Gainesville, Fla.-based national manufacturer and distributor of orthopedic implant devices and supplies, simultaneously agreed to 12-month deal with the justice department to federal monitoring. 'This is a reasonable resolution, giving Exactech credit for positive steps it has taken while requiring continued reform and compliance to avoid more serious consequences,' acting U.S. Attorney Gilmore Childers said in a statement released by his office. 'The agreement does not erase the past, but supports a future corporate culture that will not tolerate kickbacks as business as usual. Unlawful consulting relationships compromise the integrity of our healthcare system, and we will continue to hold institutions and individuals accountable who are willing to put profits over patients.' Exactech is charged in a criminal court complaint with conspiring to violate the federal anti-kickback statute. The complaint alleges that from 2002 through late 2008, Exactech entered into consulting agreements with certain orthopedic surgeons — deals which were designed and implemented, in part, to induce the surgeons to use, and cause the purchase of, Exactech's hip and knee reconstruction and replacement products, according to Childers' office.</blockquote>Note that probably because this case was small in monetary terms, reporting about it was fragmented and brief, making it very difficult to get a sense of what really was going on.  So, while Exactech did not admit to any wrong-doing, one of its mid-level managers admitted to apparently just the sort of wrong-doing of which the company was accused. If that manager was only a lone loose cannon, why would the company have been pushed to change how it uses surgeon consultants, and why would it need "support" for "a corporate culture that will not tolerate kickbacks as business as usual?" Nonetheless, only that one mid-level manager admits he did anything wrong.  If anyone else did anything wrong, who they were, and what they did remains unclear, hidden within a swirl of legalese.  Maybe unethical practices occurred, and maybe the new deferred prosecution agreement will prevent further unethical practices, but who can tell?  If anything unethical did happen, there seems to no longer be any mechanism in health care to find out and  do something about it.  This case appears to be a good example of how language can be tortured by legalistic parsing that avoids the fundamental ethical problems that now plague health care. As Dr Bernard Carroll <a href="http://hcrenewal.blogspot.com/2010/12/impeachment-its-about-institution-not.html">posted</a> recently, "legalistic charges and defenses are not the right way to go in exposing and ejecting bad actors from our field," because this approach "favors the bad actors, who flaunt their constitutional protections with the taunt, prove it."  Instead, as Dr Carroll implied, the standard in health care should require more than just avoiding felony convictions. Even though the current case is small in monetary terms, it is a marker of unethical behavior.  The ongoing parade of legal settlements and <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal </a>pleadings and convictions involving health care organizations, when viewed in its entirety, should convince professionals and policy-makers that health care is undergoing an ethical meltdown.  The fines imposed by the settlements have never been large enough to be more than costs of doing business, and hence are unlikely to change behavior.  The legalistic approach has not resulted in more than a few people who authorized, directed, or implemented the bad behavior that lead to the settlements paying any personal penalties.  If we want the bad behavior to stop, we clearly need some other way to deter it.  Until we come up with one, expect it to continue, and to continue driving up costs, driving down access, and making patients' outcomes worse.

Exactech Settles, Its Regional Sales Director Pleads Guilty

The march of legal settlements by health care organizations continues. Here is a curious story in two parts. The first part was reported ...

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Unintended errors with EHR-based result management: a case series, and a special pleading for health IT

<div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;">As I wrote at "<a href="http://hcrenewal.blogspot.com/2010/11/report-of-amia-special-task-force-on.html">Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT</a>", articles in the premier journal of Medical Informatics, the Journal of the American Medical Informatics Association (JAMIA) on real and potential downsides of health IT appear to be becoming a trend. Another article just appeared in JAMIA as the result of a study of healthcare IT related errors: "<a href="http://jamia.bmj.com/content/17/1/104.abstract">Unintended errors with EHR-based result management: a case series</a>"; Thomas R Yackel and Peter J Embi; JAMIA 2010 17: 104-107; doi: 10.1197/jamia.M3294. The article presents a series of health IT-related errors and categorizes them systematically, and thus adds to our knowledge on the issue of cybernetic clinical test results management. It also makes recommendations for increased vigilance and remediation. The abstract is below (access to the article itself requires a JAMIA subscription.) <blockquote>ABSTRACT Test result management is an integral aspect of quality clinical care and a crucial part of the ambulatory medicine workflow. Correct and timely communication of results to a provider is the necessary first step in ambulatory result management and has been identified as a weakness in many paper-based systems. While electronic health records (EHRs) hold promise for improving the reliability of result management, the complexities involved make this a challenging task. Experience with test result management is reported, four new categories of result management errors identified are outlined, and solutions developed during a 2-year deployment of a commercial EHR are described. Recommendations for improving test result management with EHRs are then given.</blockquote> The article begins: <blockquote> Over a 2-year period from 2005 to 2007, coinciding with the first 2 years of a planned 3-year deployment of the ambulatory EHR to multiple practice sites, the vast majority of laboratory result routing events functioned as intended. However, seven error types were identified as causing a substantial delay or disruption in result delivery to providers’ electronic inboxes [no statement is made about patient harm or "close calls" that may have resulted - ed.] and led to further investigations and case finding by our group. Upon analysis, these seven error types were logically grouped into four distinct error categories: (1) interface and results routing logic errors, (2) provider record issues, (3) EHR system settings, and (4) system maintenance. </blockquote> This was at OHSU, a leading institution in medical informatics, not at some organization that's a newcomer to health IT. Each of the "error categories" is described in some detail. The article then makes recommendations for improved systems, which sound simple, but are going to be far more resource intensive on a national scale than meets the eye: <blockquote> 1. Develop fault-tolerant systems that automatically report delivery failures. 2. Use robust testing to find rare errors that occur both within and between systems. 3. Implement tracking mechanisms for critical tests, such as cancer screening and diagnostics. 4. Deliver results directly to patients.</blockquote> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;">I find myself uncomfortable with the possible human resource costs of implementing the recommendations, especially on a national scale. These costs would be over and above the hundreds of millions per institution and the hundreds of thousands per private doctor already spent, or planned to be spent. My other issue regarding the article (my main issue, actually) is its editorializing for a product, health IT, in a scientific article, and making a special pleading for the technology. The next to last paragraph of the article appears more of an editorial, perhaps to make vendors comfortable, than a scientific statement of fact supported by the article: </div> <div dir="ltr" style="font-family:arial;"> </div> <blockquote style="margin-right: 0px;font-family:arial;" dir="ltr"> <div dir="ltr"> <div dir="ltr">Finally, while it might be tempting to attribute the errors noted above to the use of a particular health information system or even Health IT in general, an examination of the cases reveals that most of these errors actually resulted from local configuration and implementation decisions rather than to the technologies themselves. Indeed, the authors believe that these cases further support the emerging truism [wow! This is news to me - ed.] that errors related to Health IT are in most cases the result of human error in the implementation of new information and communication systems into our existing complex healthcare environments.[10] Therefore, we contend that the main lesson arising from these cases is that care must be taken by those responsible for implementing health information systems to remain aware of the kinds of errors that might occur and monitor for the unexpected consequences that will undoubtedly take place, but not to avoid use of such systems that likely have the capacity for far greater benefit than harm, if implemented and monitored properly.</div></div></blockquote> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> In this paragraph the authors state: "... while it might be tempting to attribute the errors noted above to the use of a particular health information system or even Health IT in general, an examination of the cases reveals that most of these errors actually resulted from local configuration and implementation decisions rather than the technologies themselves." <blockquote>Sept. 2011 addendum: the article was written before Dr Jon Patrick's expose of examples of the internal flaws of commercial health IT, as here: <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">link</a>, <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">link</a>.</blockquote> As for "rather than the technologies themselves", technologies themselves are never a problem by themselves, even the atomic bomb. In a reductio ad absurdum, which is maybe not so absurd, it took a B29 Superfortress to drop two A-bombs; the bombs could have been deactivated and put in a museum instead. However, consider a poorly designed A-bomb that could unpredictably go "BOOM" - now that would be a problem. While I agree some errors are due to mismanaged implementation, in the article, no differentiation is made of design issues vs. implementation (i.e., local configuration and implementation decisions). Yet fundamental design is crucial, according to industry leaders and non-industry experts, in areas that cannot be vastly improved by local configuration decisions: </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> <div dir="ltr">HIMSS's former Chairman of the Board admits the <a href="http://hcrenewal.blogspot.com/2010/07/barry-chaiken-md-mph-lets-be-patient.html" target="_blank">technology remains experimental</a>: </div> <blockquote style="margin-right: 0px;" dir="ltr"> <div dir="ltr">... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better; </div></blockquote> <div dir="ltr">While HIMSS itself admits <a href="http://www.himss.org/content/files/himss_definingandtestingemrusability.pdf" target="_blank">in this 2009 PDF</a> that </div> <blockquote style="margin-right: 0px;" dir="ltr"> <div dir="ltr">"Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available"; </div></blockquote> <div dir="ltr">While the National Research Council (the highest scientific authority in the U.S.) last year <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_blank">reported that</a>: </div> <blockquote style="margin-right: 0px;" dir="ltr"> <div dir="ltr">"Current Approaches to U.S. Health Care Information Technology are Insufficient" and that the technology "does not support clinicians' cognitive needs." The study was chaired by Medical Informatics pioneers Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt); </div></blockquote></div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> It is very difficult if not impossible to make a clinical IT silk purse out of a poorly designed sow's ear, no matter how many sound "local configuration and implementation decisions" are made. Further, it is stated in the JAMIA article that human errors in implementation as the cause of health IT woes are an "emerging truism". </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;">Making the case that some observation reflects a "truism" is a powerful claim. Such a claim deserves more than one reference, but here's what we have: </div> <blockquote style="margin-right: 0px;font-family:arial;" dir="ltr"> <div dir="ltr">"... the authors believe that these cases further support the emerging truism that errors related to Health IT are in most cases the result of human error in the implementation of new information and communication systems into our existing complex healthcare environments" [10]. 10. Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Med Inform Assoc 2004;11:104–12. </div></blockquote> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> Perhaps the term "truism", emerging or otherwise, should be avoided in 2010 regarding errors related to health IT. The authors contend, presumably from the above observations that: </div> <blockquote style="margin-right: 0px;font-family:arial;" dir="ltr"> <div dir="ltr">... we contend that the main lesson arising from these cases is that care must be taken by those responsible for implementing health information systems to remain aware of the kinds of errors that might occur and monitor for the unexpected consequences that will undoubtedly take place</div></blockquote> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> "Might occur?" How about "that do occur" - as in the paper? Above all, these involve patients. Unexpected consequences - these involve patients, too. My relative was nearly killed by "unexpected consequences:" of health IT in May 2010. Perhaps that makes me less cavalier about health IT. In fact, the certainty that UC's will "undoubtedly take place" reaffirms that these are still experimental technologies. I remind that it might be best to focus on fundamental design issues before expensive systems are put into place that can cause errors and unexpected consequences, because these are mission critical systems involving live patients who have not, incidentally, been afforded informed consent to the use of these medical devices in their healthcare.</div> <div dir="ltr" face="arial"> </div> <div dir="ltr" style="font-family: arial;"> Another editorial comment follows: </div> <blockquote style="margin-right: 0px;font-family:arial;" dir="ltr"> <div dir="ltr">[the lesson is that those responsible should remain aware] but not to avoid use of such systems that likely have the capacity for far greater benefit than harm, if implemented and monitored properly</div></blockquote> <div class="PlainText" style="font-family:arial;"> </div> <div class="PlainText" style="font-family:arial;"> </div> <div class="PlainText" style="font-family:arial;"> Once again, this is an editorial and value judgment. Who knows if ultimately health IT has a capacity for far greater benefit than harm? If these systems will have predictable, unexpected consequences, how do we know that? Why should critical-thinking practitioners not avoid such systems for now until a better understanding of how to design them to improve usability and support clinician cognition is achieved? Why put patients at risk en masse as part of a national experiment when studies even at advanced HIT sites show fundamental problems that could harm or kill? I argue this paper and others that are "emerging" on the downsides and lack of ROI of health IT make the case for great caution and slowness (i.e., avoidance) in their adoption. Yet the authors seek special accommodation for this technology, something that is perhaps unprecedented with (unregulated) medical devices of unknown risk. The lesson is actually that we need to slow down with HIT; reboot and start to solve the problems of this technology before national rollout attempts. This is the ethical position regarding any experimental medical technology that is proving risky at a level not clearly known. -- SS </div> <div class="PlainText" style="font-family:arial;"> </div>

Unintended errors with EHR-based result management: a case series, and a special pleading for health IT

As I wrote at " Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT ...

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High Heels, Short Skirts, and Recruiting Bone Marrow Donors

Once again, you just can't make this stuff up.  Here is the New York Times <a href="http://www.nytimes.com/2010/12/17/us/17models.html">description</a> of new state of the art in recruiting donors for bone marrow transplant. <blockquote>On its face, it seemed reasonable enough: a bone marrow registry sending recruiters to malls, ballparks and other busy sites to enlist potential donors. But the recruiters were actually flirtatious models in heels, short skirts and lab coats, law enforcement officials say, asking passers-by for DNA swabs without mentioning the price of the seemingly simple procedure. And the registry, Caitlin Raymond International, was paying up to $60,000 a week for the models while billing insurance companies up to $4,300 per test. In New Hampshire, where prosecutors say thousands of people appeared to have provided swabs, the attorney general is investigating the registry’s marketing and billing practices. The registry is a nonprofit subsidiary of UMass Memorial Medical Center in Worcester, which said Thursday that it had stopped seeking donors in New Hampshire and using models altogether. James T. Boffetti, the state’s senior assistant attorney general, said the registry had hired models based on their photographs and had given them 'explicit instructions' to wear heels and short skirts. </blockquote> The recruitment seemed to be based more on in-your-face sex appeal than an appeal to altruism: <blockquote>'The models worked the crowds, if you will,' he said. 'We were told basically they would engage a lot of younger men with some sort of flirtatious thing: ‘Hey, don’t you want to be a hero? Come on, do this!’ ' </blockquote> What the models did not tell their, um, prospects was that apparent acts of charity would result in a hefty bill to the volunteers' health insurance: <blockquote>They got people to do this without telling them it could be a charge of $4,300 against their insurance</blockquote> To put that charge in perspective, as <a href="http://www.boston.com/news/local/massachusetts/articles/2010/12/18/surge_in_marrow_testing_probed/">reported</a> by Liz Kowalczyk in the Boston Globe: <blockquote>In the last decade, Massachusetts, New Hampshire, and Rhode Island became the only states where legislators mandated insurers pay for bone marrow testing. Nationally, most hospitals and other donor-recruitment organizations do not charge for the testing, said Michael Boo, chief strategy officer for the National Marrow Donor Program. The test typically involves a DNA analysis to determine whether the donor is a match for anyone on the bone marrow transplant waiting list. Boo estimates it costs the organization about $100 to test and recruit each potential donor, although he said that, as the largest bone marrow donor registry in the United States, the program gets a volume discount from labs for the DNA analysis. The organization has about 8 million registered donors. (The Caitlin Raymond registry has 185,000 potential donors.) But in New Hampshire, UMass Memorial charges self-insured employers, like the city of Manchester, that do not have a negotiated rate upwards of $4,000 per person for testing. It generally has charged insurers like Blue Cross and Harvard Pilgrim $700 to $1,500 person for testing, said James Boffetti, senior assistant attorney general in New Hampshire and chief of the consumer protection bureau. 'We haven’t been able to get a clear explanation from UMass about the reasons for the costs,' he said. As for the unusual recruiting, he said, 'they’re doing it because they are making money on this test.'</blockquote> Finally, although the medical center sent initial bills for the tests to volunteers' insurers, sometimes the volunteers got stuck with part of the bill. As <a href="http://www.npr.org/2010/12/17/132121651/mass-n-h-take-aim-at-bone-marrow-registry">reported</a> by National Public Radio: <blockquote>Marc Ferland, a 45-year-old father of two in Bow, N.H., stopped at a registry booth after giving blood at a Red Cross drive. A month later, he received a bill that said he owed more than $2,000 to cover the costs of the test. When he complained, the amount was cut to $760, which he paid out of a health care account offered by his employer. 'When you take money out of my spending account, that's a cost to me,' Ferland said.</blockquote> So here is an almost unbelievable example of how the a culture of marketing gone amok has taken over an academic health care institution. It seems darkly humorous now that the UMass Memorial Medical Center includes in its <a href="http://www.umassmemorial.org/MissionVisionandValues">stated values</a>: <blockquote>Staff members of UMass Memorial Medical Center are committed to: * Excelling at patient-centered care Achieving patient-focused excellence through the highest standards of quality care, patient safety and patient satisfaction * Acting with integrity Dealing honestly, fairly and responsibly with each other * Respecting one another Valuing the contributions, ideas and opinions of our coworkers, colleagues, patients and partners * Contributing to the community Partnering with the community at large and with other health care and social agencies in meeting the health needs of the community * Improving through teamwork and systems thinking Working to continuously improve ourselves, our processes and our patient services through cooperation and thinking as an integrated health care system * Embracing accountability Holding ourselves, our coworkers and our leaders to the highest standards of performance</blockquote> Integrity? Partnering with the community? - maybe that is what some of the recruits were hoping for, in a sense.   Embracing accountability?  Maybe the new vision statement should be "a sucker is born every minute." Again, it would be funny if it were not so tragic.  Here we see a major academic medical institution debased into something that a Las Vegas casino might frown upon. As we have noted ad infinitum, however, previous attempts at health care reform have not dealt with how the "greed is good" culture of Wall Street, run by amoral financiers and fueled by cynical marketers, has taken over health care.  Until we get health care leaders who really do care about patients, and about the integrity of teaching and research, the show will go on.  Meanwhile, the suckers better watch out.

High Heels, Short Skirts, and Recruiting Bone Marrow Donors

Once again, you just can't make this stuff up. Here is the New York Times description of new state of the art in recruiting donors for...

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BLOGSCAN - Medtronic's Multi-Million Dollar Payments to Spine Surgeons

Starting in 2007, we discussed the huge payments made by four medical device companies to orthopedic surgeons and medical organizations related to the use of hip and knee prostheses.  (See post <a href="http://hcrenewal.blogspot.com/2010/06/deferred-prosecution-agreements-end-so.html">here</a> with links backward.)  Payments, in the millions of dollars per year range, went to surgeons including noted academics, and leaders of the main orthopedic physicians' society.  Payments went to medical schools, teaching hospitals, and professional societies.  Many of these financial relationships were not disclosed, and the disclosures that were made rarely indicated the amounts involved. Now <a href="http://online.wsj.com/article/SB10001424052748703395204576024023361023138.html">the Wall Street Journal</a> reports millions being paid to spine surgeons by Medtronic in connection with devices used in spinal fusion.  See Dr Howard Brody's discussion <a href="http://brodyhooked.blogspot.com/2010/12/highest-rolling-spine-surgeons-digging.html">here</a> on the Hooked: Ethics, Medicine, and Pharma blog, and also Felix Salmon's discussion <a href="http://blogs.reuters.com/felix-salmon/2010/12/20/are-surgeons-getting-kickbacks-from-medtronic/">here</a> on the Felix Salmon blog. What seems lacking is a clear rationale for any payments, much less for payments of the sizes listed.  The WSJ article cited a Medtronic spokesperson, "surgeons' device-development work goes beyond mere consulting when the company deems that they are contributing valuable intellectual property to a product. But that intellectual property doesn't necessarily have to be patented."  The reporters found, "search of spine-device patents awarded to the Norton surgeons turned up about a dozen total for Drs. Puno, Johnson, Campbell and Dimar, most owned by companies other than Medtronic. The search turned up no patents for Dr. Glassman."  So what intellectual property that was not or could not be patented could be worth millions a year?

BLOGSCAN - Medtronic's Multi-Million Dollar Payments to Spine Surgeons

Starting in 2007, we discussed the huge payments made by four medical device companies to orthopedic surgeons and medical organizations rela...

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Meaningful Use and the Devil in the Details: A Reader's View

A reader, Dr. Scott Monteith, a psychiatrist, shared his thoughts on government-mandated 'Meaningful Use' of Electronic Medical Records ('MU') with me after reading a number of my EHR posts, and asked if he could share his thoughts via Healthcare Renewal. Dr Monteith is a graduate of the University of Michigan and Michigan State University where he was chief resident. He is a board certified psychiatrist, clinical assistant professor in the departments of psychiatry and family medicine at Michigan State University, and has worked in the same community health center for 20 years serving people suffering from severe and persistent mental illness. His interest in Health Information Technology goes back over 20 years. He has served as a CCHIT Juror, was appointed by Michigan’s Governor Granholm to the Controlled Substances Advisory Commission which has an oversight role for the Michigan Automated Prescription System, and was a member of the Business Operations group of the Michigan Health Information Network. Dr. Monteith writes:  <blockquote>From Medical Economics:“While 85% of physicians were aware of the financial incentives for implementing an electronic health record (EHR) system, more than 35% did not know that they face government-assessed financial penalties for not complying, according to a survey of more than 500 physicians by Physicians' Reciprocal Insurers, a New York-based medical liability insurance company. The penalties are equal to a 1% reduction of the physician's annual Medicare payments per year up to 5%. However, those penalties do not seem to be having the intended effect, as more than 65% of physicians who were unaware of the financial penalties said this would not cause them to implement system."The above Medical Economics article reflects a reality that is consistent with what we are seeing in the clinical ‘trenches.’Eligible Providers (EPs) are realizing that Meaningful Use (MU) incentives are not as simple as…using a certified EHR + being part of Medicare and/or Medicaid + applying for MU + attesting to MU.Receiving $44k (or $64k) in incentives seems not only increasingly elusive, but of questionable benefit even if some or all of the incentives are realized. The ‘carrot & stick’ of Meaningful Use (MU) seems to increasingly be viewed as ‘meaningless and useless’ by at least some clinicians. Some are asking if ‘MU’ will stand for ‘meaningless and useless’ in the future. There seems to be a long list of reasons why MU is so challenging. From what I have gleaned, there appear to be two main issues: 1. the cost to meet MU may be too high (and, said another way, the ROI might be too low); and 2. there are too many uncertainties associated with MU (largely stemming from the risk of burdensome bureaucratic entanglement – an unknown and potentially huge “cost”). As we know, MU reimbursement flows through two streams: Medicare and Medicaid. And one’s incentive dollars and/or penalties are based on Medicare/Medicaid volume. So small Medicare/Medicaid volume means small incentives/penalties. With the perception of inevitable Medicare and Medicaid cuts, these two funding streams become increasingly irrelevant for more and more providers. Another issue stems from the fact that MU and the associated EHR “certification” are losing credibility because they do not address “usability.” My users simply want EHRs that “work,” and “work” well (like their iPhones). Users ultimately want and expect usability. They hoped that certification would help guide them in this important respect, but they are finding that is not the case. To the extent that certification is not meaningfully addressing ‘usability,’ therefore, MU is viewed as ‘useless’ in guiding purchasing decisions. Further, many are simply not confident that they will meet MU. Other challenges I’ve encountered include: <ul style="font-family:arial;"><li>One big problem with MU is that many people believe that wedding one’s self to MU (ARRA) will open a can of bureaucratic worms (and they might be correct)</li></ul> <ul style="font-family:arial;"><li>MU is 864 pages of details. How many users will read all 864 pages of the government’s final rule for MU? (And of those few who do, how many will understand it?). If one doesn’t know the MU rules, how will one prepare for MU? Hire consultants and IT experts? How much will this cost?</li></ul> <ul style="font-family:arial;"><li>How will one establish that one is MU-certified? In year one there will be self-attestation. But who/what will certify users as to whether or not users are meeting MU in the other years? How much will it cost (direct costs to pay above certification organization/entity)?</li></ul> <ul style="margin-top: 0in;font-family:arial;" type="disc"><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">How much will it cost users to become certified (indirect costs to prepare for your certification)? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">Currently it appears that one must recertify every year for incentives. But how often will one have to recertify to avoid penalties? What will be the ongoing cost in terms money, time, energy, business flow? Will the ROI be positive or negative (and how positive or negative)?</li></ul> <ul style="font-family:arial;"><li>To what future governmental audits might one be subjected if one gets incentive dollars and/or wants to avoid penalties (especially after the inevitable celebrated cases of abuse)? It is not hard to imagine receiving a letter from the government that says, in essence: “You self attested that you met MU in year one. You are now being audited to substantiate your attestation.”</li></ul> <ul style="margin-top: 0in;font-family:arial;" type="disc"><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">How many people will be audited after receiving ARRA dollars? How much time will the audit take? For how long will you need to keep records? What records? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">What will Congress (and the FBI) do when someone gets ARRA dollars through the “incentives” (or avoids “penalties” in the penalty phase), but they haven’t properly completed the MU certification process, or properly/fully documented it (perhaps no fault of their own)?</li></ul> <ul style="font-family:arial;"><li>What liability does one incur by claiming to meet MU, but then later discovering that someone in the government says that you have not met MU?</li></ul><ul style="font-family:arial;"><li>Given that one needs to do things for MU that establish X percent of a given function (e.g., Rxs) are accomplished through an EHR, one needs both a numerator and denominator to establish the percentage. But how does one capture the data to establish MU percentages for Rxs (and other tasks) that are done on paper?</li></ul> <ul style="font-family:arial;"><li>Are incentive dollars taxable? The answer appears to be “yes.” But many doctors are already “signing over” their dollars to institutions. Unfortunately, neither the doctors nor the institutions are making accommodations for the tax implications. That is, what happens when institutions get the dollars, but because the dollars flow through the clinician, the clinician gets the tax bill?</li></ul> <ul style="margin-top: 0in;font-family:arial;" type="disc"><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">What happens if you change EHRs, for example, due to moving to new practice? Will you have to start all over again? Will you have to reimburse the government? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">Today there are over 400 EHR vendors. In five years, it is expected that at least 350 will ‘go under’ (no longer exist). What then? Recertify? Give back ARRA dollars? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">Will the goal line (either in terms of criteria or time) for MU be moved? (It might move; some say it definitely will move.) How often will this occur? What are the implications for your MU and any ARRA dollars that you have received? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">The Republican “Pledge” is calling for no incentives be spent (including related to HIT).</li></ul> </blockquote>Of course, my own opinion is that setting standards for "meaningful use" implies that use of EHR's can be meaningful to the doctor & patient (rather than to the government and to payors); the literature is conflicting on this point. Further, doing do at a time when HIT is widely acknowledged to be of poor usability (even by HIMSS itself) is putting the cart before the horse, as I wrote at my post "<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?</a>" We report; you decide. -- SS

Meaningful Use and the Devil in the Details: A Reader's View

A reader, Dr. Scott Monteith, a psychiatrist, shared his thoughts on government-mandated 'Meaningful Use' of Electronic Medical Reco...

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"Drug companies are now No. 1 When it Comes to Defrauding the Government"

A new <a href="http://www.citizen.org/hrg1924">report</a> from Public Citizen, as <a href="http://www.npr.org/blogs/health/2010/12/17/132134328/when-it-comes-to-government-fraud-health-care-now-tops-defense">summarized</a> by National Public Radio: <blockquote>Drug companies are now No. 1 when it comes to defrauding the government, leaving defense contractors in the dust. A report from the consumer group Public Citizen says financial penalties against drug companies under the federal False Claims Act far outstripped defense contractors between 2007 and 2010.</blockquote> The problem has been getting worse recently: <blockquote>Documented pharma fraud has been accelerating lately, Public Citizen says. It looked at fines and settlements paid by drug companies over two decades. Since 1991 those penalties totaled $19.8 billion. But three-quarters of those occurred over the past five years.</blockquote> Regarding the biggest offenders: <blockquote>Just four giant drug companies – GlaxoSmithKline, Pfizer, Eli Lilly and Schering-Plough – account for more than have the pharma penalties over the past two decades. They belong to the Billion Dollar Club — companies that have paid out settlements of $1 billion or more. Altogether the four have paid $10.5 billion back to the government.</blockquote> Reading the report itself makes the acceleration of drug company fraud settlements even more apparent (p. 12): <blockquote>Data from the Department of Justice shows that annual federal FCA settlement totals for all industries have increased dramatically over the past 20 years, from $341 million in fiscal year (FY) 1991 to $3 billion in FY 2010. The proportion attributed to all Health and Human Services (HHS) cases (i.e., cases that involve pharmaceuticals and other health care industries), increased from 4 percent of the total in FY 1991 to 84 percent in FY 2010.</blockquote> Furthermore, <blockquote>the pharmaceutical industry did not comprise a substantial portion of federal FCA penalties until FY 2002, when it overtook the defense industry for the first time. For every year since and including FY 2007, the pharmaceutical industry total has far exceeded the defense industry total. As stated above, the total healthcare industry (as represented by HHS totals), has been the biggest defrauder of the federal government under the FCA for most of the past decade. Defense industry payments and the combined total for all other (non-defense and non-HHS) sectors each represent an amount smaller than the pharmaceutical industry total alone since FY 2007. In addition, since FY 2008, the pharmaceutical industry’s FCA payments have exceeded the total law-violation payments of each of the other sectors within the health industry.</blockquote> Of course, data about settlements of US False Claims Acts claims is only one, limited measure of unethical and criminal behavior. However, in lieu of better data, it is striking that the vast majority of such settlements are now by the health care sector, and the pharmaceutical industry in particular accounts for the biggest share of such claims within that sector.   In my opinion, these data illustrate just how unethical, if not corrupt, health care in the US has become. It is particularly appalling because health care is not just another "industry," but traditionally was regarded as a calling to relieve suffering, and when possible prevent or cure disease. Traditionally, health care practitioners and health care institutions were held to higher standards than other industries, like the defense industry, or the trash hauling industry. Now, however, it appears that the health industry holds itself to the lowest standards.  Is it any wonder that our health care system is dysfunctional, or that our costs constantly rise, while access and quality decline. This data should prompt massive outrage, and lead to yet more ringing calls (like those we discussed recently <a href="http://hcrenewal.blogspot.com/2010/12/health-professionals-for-new-century.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/12/lancet-emphasizes-threats-to-academic.html">here</a>) for reform, at least of specific aspects of health care.  I doubt that will happen, however, because these data, like so much of the cases and data we discuss on Health Care Renewal, probably will be muffled by the anechoic effect. Despite its striking results, this report has not been covered in print by any major market newspaper. (Duff Wilson did <a href="http://prescriptions.blogs.nytimes.com/2010/12/16/drug-makers-are-paying-big-settlements">blog</a> about it for the New York Times.) The only US newspaper coverage so far appears to be in <a href="http://www.theday.com/article/20101218/BIZ02/312189912/-1/BIZ">the New London (CT) Day</a>. There has been no coverage on US television. The Public Citizen report noted that the largest settlement for clinically related reasons was by Pfizer of $2.3 billion for unlawful promotion and kickbacks (see blog posts <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">here</a>). Despite the apparently staggering size of this settlement, a Google Scholar search revealed only one mention of it, and that rather tangential, in a large circulation US medical journal, the New England Journal of Medicine.(1) It was mentioned in the news sections of two major journals outside of the US, the British Medical Journal(2) and the Canadian Medical Association Journal.(3) So unless US health care is about to change drastically, I do not expect any discussion of this data in the medical and health care literature. The likelihood that this report will be noticed by most physicians, health care researchers, or health care policy makers is almost nil. Why does such striking information create so few ripples?  It has never been formally studied, to may knowledge. However, I suspect it has to do first with the vast web of conflicts of interest that now drapes over health care.  As we have mentioned before, the majority of US medical school faculty,(4) and the majority of US medical schools' department chairs(5) have significant financial relationships with industry, often the pharmaceutical industry.   Some leaders of US academic mission are simultaneous members of boards of directors of for-profit health care corporations (e.g., see <a href="http://hcrenewal.blogspot.com/2010/12/duke-divinity-students-protest-pay-of.html">this example</a>), and thus have fiduciary responsibilities towards those corporations.  Thus, how many academics are going to want to offend their employers, or their colleagues' and supevisors' employers, by writing about such recent unpleasantness as billion dollar pharmaceutical settlements for fraud?  Second, it probably has to do with the power derived from the wealth of the leaders of pharmaceutical corporations, wealth they seem to amass no matter what ethical violations their companies pile up.  For example, according to the <a href="http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1odHRwOi8vaXIuaW50Lndlc3RsYXdidXNpbmVzcy5jb20vZG9jdW1lbnQvdjEvMDAwMTE5MzEyNS0xMC0wNTc5NDkvZG9jLzAwMDExOTMxMjUxMDA1Nzk0OS5wZGYmdHlwZT0yJmZuPTAwMDExOTMxMjUxMDA1Nzk0OS5wZGY=">2010 Pfizer Proxy Statement</a>, Mr Jeffry Kindler, the CEO of Pfizer through this year, currently owns the equivalent of  1,084,212 shares of Pfizer stock (worth $18,615,920 at <a href="http://www.google.com/finance?q=pfizer">today's price</a> of $17.17/ share), has the rights to 1,996,000 stock options, and received $5,534,285 total compensation in 2009, $7,553,015 in 2008, and $4,469,760 in 2007.   I can only hope that the anechoic effect eventually breaks down, and a movement to truly reform US health care eventually develops.  True reform will require holding health care organizations to higher, not lower standards than trash haulers and gambling casinos, and regarding working in health care as a calling, rather than a means to satisfy one's greed.   Hat tip <a href="http://www.margaretsoltan.com/?p=28337">to Prof Margaret Soltan</a> on the University Diaries blog. ADDENDUM (21 December, 2010) - See also <a href="http://www.margaretsoltan.com/?p=28381">this comment</a> by Prof Margaret Soltan on the University Diaries blog, and comments (<a href="http://shearlingsplowed.blogspot.com/2010/12/astonishing-or-not-so-198-billion.html">here</a> and <a href="http://shearlingsplowed.blogspot.com/2010/12/meet-pharma-new-fraud-kings-path-to.html">here</a>) by "Condor" on the Shearlings Got Plowed blog. References 1. Kesselheim AS, Studdart DM, Mello MM. Whistle-Blowers' experiences in fraud litigation against pharmaceutical companies. N Engl J Med 2010; 362:1832-1839. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsr0912039">here</a>. 2. Tanne JH. Pfizer pays record fine for off-label promotion of four drugs. Br Med J 2009; 339:b3657. Link <a href="http://www.bmj.com/content/339/bmj.b3657.full">here</a>. 3. Anonymous. Federal committee to review Pfizer v-p appointment to CIHR council. Link <a href="http://www.cmaj.ca/cgi/rapidpdf/cmaj.109-3113v1.pdf">here</a>. 4. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa064508">here</a>. 5. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. Link <a href="http://jama.ama-assn.org/content/298/15/1779.full">here</a>.

"Drug companies are now No. 1 When it Comes to Defrauding the Government"

A new report from Public Citizen, as summarized by National Public Radio: Drug companies are now No. 1 when it comes to defrauding the gov...

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