healthy4u: Kyphon

The case of the over-marketing of Kyphon's kyphoplasty device (look <a href="http://hcrenewal.blogspot.com/2008/05/corporate-integrity-agreement-for.html">here</a>) just got more complicated, and now appears to have involved an amazing number of players. The State of Play  As reported by the AP (<a href="http://www.washingtonpost.com/business/justice-department-55-hospitals-reach-34-million-settlement-over-medicare-fraud-claims/2013/07/02/3d3d2356-e34e-11e2-bffd-37a36ddab820_story.html">via</a> the Washington Post), <blockquote class="tr_bq"> Fifty-five hospitals in 21 states have agreed to pay $34 million to the U.S. government to settle allegations that they used more expensive inpatient procedures rather than outpatient spinal surgeries to get bigger payments from Medicare, the U.S. Justice Department said Tuesday. The settlement involves kyphoplasty procedures used to treat spinal fractures usually caused by osteoporosis. It can be done as an outpatient procedure, but he Justice Department said the hospitals performed the surgeries as inpatient procedures to increase Medicare billings.</blockquote> The current media reports provided little detail about the allegations, but did note that this case has been litigated for a while, <blockquote class="tr_bq"> A similar settlement was reached last year, when 14 hospitals agreed to pay a settlement of more than $12 million. And in 2008, the Justice Department agreed to a $75 million settlement with Medtronic Inc.’s spine business. The government was investigating allegations that Kyphon, a company that had been acquired by Medtronic Spine in 2007, advised hospitals to do inpatient kyphoplasties to bulk up their Medicare payments.</blockquote> The Players Per the AP, there were quite a few <blockquote class="tr_bq">In the latest settlement, the largest payments are being made by Atrium Medical Center of Middletown, Ohio, which will pay $4.2 million; Mount Sinai Medical Center in Miami, $1.8 million; Altru Health System of Grand Forks, N.D., $1.5 million; Cedars Sinai Medical Center in Los Angeles, $1.5 million; Wayne Memorial Hospital in Goldsboro, N.C., $1.3 million; Trover Health System of Madisonville, Ky., $1.2 million; The Queen’s Medical Center in Honolulu, $1.1 million; and Des Peres Hospital in suburban St. Louis, $900,000. Several multi-hospital organizations agreed to settlements, including: —Twenty-three hospitals with <a href="http://hcrenewal.blogspot.com/search/label/HCA">HCA Inc</a>. of Nashville, Tenn., paying a total of $7.1 million. —Six hospitals with Lifepoint Hospitals Inc. of Brentwood, Tenn., $2.5 million. —Five hospitals with Trinity Health of Livonia, Mich., $3.9 million. —Four hospitals with Morton Plant Mease BayCare Health System of Clearwater, Fla., $2.4 million. —Three hospitals with Baptist Memorial Hospital-Golden Triangle of North Columbus, Miss., $1.8 million. —Two hospitals with Bayhealth Medical Center of Newark, Del., $1.1 million.</blockquote> A Modern Healthcare <a href="http://www.modernhealthcare.com/article/20130702/NEWS/307029967/55-more-hospitals-settle-in-kyphoplasty-overpayment-cases">report</a> noted that the leadership of HCA, the hospital system with the largest liability, made it out to all be a misunderstanding, <blockquote class="tr_bq">Hospital executives say the allegations are prompted by  unclear Medicare rules on when spinal-surgery patients should be held overnight. And they note that even though the whistle-blowers and the government are targeting hospitals, the decision to admit patients is usually dictated by the treating physician. 'We are pleased to see new clarification of industry care standards, which help physicians make decisions regarding kyphoplasty patients,' HCA spokesman Ed Fishbough said in an e-mailed statement Tuesday. 'We are confident as a result that this issue has been resolved.'</blockquote> However, the case appears to be more complicated than that. What Really Happened, and Who Benefited? In fact, we <a href="http://hcrenewal.blogspot.com/2008/05/corporate-integrity-agreement-for.html">discussed</a> the Medtronic settlement in 2008.  At that time, a New York Times <a href="http://www.nytimes.com/2008/05/23/business/23device.html">article</a> described the government's allegations about what went on this way, <blockquote class="tr_bq">A unit of Medtronic defrauded Medicare of hundreds of millions of dollars, according to a civil lawsuit that was unsealed Thursday and simultaneously settled with the Justice Department. Two insiders had said Kyphon, which Medtronic acquired in 2007, improperly persuaded hospitals to keep people overnight for a simple outpatient procedure to repair small fissures of the spine. Medicare then reimbursed the hospitals much more generously than it otherwise would have for the procedure, which was developed as a noninvasive approach that could usually be done in about an hour. By marketing its products this way, Kyphon was able to artificially drive up demand among hospitals, bolstering its revenue and driving up its stock price. Medtronic subsequently bought the company, its competitor, for $3.9 billion, greatly enriching Kyphon’s senior executives. </blockquote> Furthermore, <blockquote class="tr_bq"> The scheme at Kyphon was based on Medicare’s practice of reimbursing hospitals more for complex inpatient back surgery than for outpatient care. The two whistle-blowers, Charles M. Bates and Craig Patrick, said Kyphon had deliberately urged doctors to admit patients overnight, knowing the admissions were unnecessary. Hospitals saw the overnight admissions as a way to raise revenue, the two said, and bought Kyphon’s products, even though they were expensive, starting at $3,500 to repair one spinal fissure. The hospitals could recover the cost through the improper reimbursements for overnight stays. Kyphon sold so much equipment this way that at one point it enjoyed a 90 percent profit margin, according to the two insiders, both of whom worked in sales positions. The former employees said the scheme began in 1999, when Kyphon’s products first came to the market. Kyphon’s rapid sales growth and profitability eventually gave rise to a patent dispute with Medtronic, which was dropped when Medtronic acquired it. The acquisition richly rewarded Kyphon’s shareholders, particularly its top executives. The company said its top 15 executives stood to receive about $145 million by cashing in their options and restricted stock.</blockquote> Note that at that time, Medtronic leadership, whose decision to purchase of Kyphon would end up so enriching Kyphon executives, seemingly had no worries, <blockquote class="tr_bq">A  spokeswoman for Medtronic, Marybeth Thorsgaard, said the company had known Kyphon was under investigation when it made the acquisition. She said it knew that Kyphon’s marketing strategy was being challenged, and took the risk of litigation into account. 'There were no surprises,' she said.</blockquote> I can find no public record that any individual who authorized, directed, or implemented the arrangements above that lead to huge overcharges to Medicare, and huge revenues to Kyphon and the hospitals was subject to any negative consequences.  As noted above, it appears that the executives who lead Kyphon at the time it was acquired by Medtronic made substantial amounts of money apparently attributable to this scheme to allegedly "defraud Medicare of hundreds of millions of dollars" (as it was described above in the New York Times).  Using the public record available on the internet, I tried to see how the top three Kyphon executives are doing now.  It appears they are not doing badly, and remain influential in health care.  According to its <a href="http://www.sec.gov/Archives/edgar/data/1123313/000119312507096257/ddef14a.htm">2007 proxy statement</a>, just before Kyphon was bought out, its CEO was Richard W Mott.  As best as I can tell, <a href="http://people.equilar.com/bio/richard-mott-alfred-university/salary/525993#.UdRnh6zNrrI">per Equilar,</a> he currently runs a consulting firm (Walkabout Consulting LLC), and was previously chairman of <a href="http://www.linkedin.com/company/photothera">PhotoThera</a>, which just went out of business.  Kyphon's chief science officer was  Karen D Talmadge, PhD, who is now on the <a href="http://www.diabetes.org/about-us/board-of-directors/karen-d-talmadge.html">board of directors of the American Diabetes Association,</a> and is also "Chair of the Board of Directors of Gynesonics, and serves on the Boards of Directors of Amplyx Pharmaceuticals, Velocity Pharmaceutical Development and Venous Health Systems."  Kyphon's chief operating officer was Arthur T Taylor, who is now on the <a href="http://www.providencemt.com/board-directors">board of directors of Providence Medical Technology</a>. The CEO of Medtronic at the time it bought out Kyphon, and the CEO of HCA at the time the arrangements began appear not to be doing badly either.  The CEO of Medtronic at the time it acquired Kyphon was Arthur D Collins Jr, who is now on the boards of directors of Boeing, Alcoa, and US Bancorp, also, according to his <a href="http://www.boeing.com/boeing/corp_gov/board_directors.page?">Boeing biography,</a> he is a senior adviser to Oak Hill Capital Partners, and is on the Board of Overseers of the Wharton School.  The CEO of HCA at the time of its arrangement with Kyphon began was Dr Thomas Frist Jr, who is currently <a href="http://www.forbes.com/profile/thomas-frist-jr/">on the Forbes list of billionaires</a> at number 262 in the world, with a total worth estimated at $4.3 billion. Summary In retrospect, this case allegedly involved arrangements between Kyphon, a device company, and multiple hospitals to increase the revenue of all parties by billing the US government for unnecessary hospitalizations occurring after the use of a device made by Kyphon.  The arrangements appeared to have been particularly lucrative for Kyphon's executives after a larger device company, Medtronic, chose to buy Kyphon. Medtronic ultimately paid a large fine and entered into a corporate integrity agreement nine years after the arrangements began.  Now fourteen years after the arrangements began, at least some of the hospitals involved have also paid fines.  The former Kyphon executives who benefited the most seemingly paid no penalties, nor seemingly did any managers of Medtronic or the hospitals who might have gotten larger compensation because of all the revenue that these arrangements generated.     So initially, the big losers from this complex dance were the US government, and ultimately US tax payers.  Some patients may have also paid out of pocket for unnecessary services and thus lost money too.  Whether some patients suffered due to adverse effects of unneeded procedures was not clear.  Much later, Medtronic and some of the hospitals involved did pay big fines and thus lost some money.  However, it does not appear that they paid anything like what they made from the original scheme, and their payments were delayed for years.  However, the insiders who personally made a lot of money never apparently paid anything later.  So, this case appears to be a vivid example of how such insiders can walk away with piles of money from the misbehavior of their own corporations, while others pay the price. Many of those of us of a certain age were brought up on myths that ultimately the good guys win and the bad guys lose.  We would all like to believe that the "arc of the moral universe ... bends toward justice."  History and this recent example suggest that it may not do so without our active intervention.  In health care, as we have said many times (look <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">here</a> for examples), when bad behavior occurs within a large health care organization, rarely are the insiders who authorized or directed it, and who had the most to gain from the behavior ever made to suffer any negative consequences.  As long as health care leaders have such impunity, expect them to continue to personally profit from unethical behavior.  As a result, expect health care costs to continue to rise as quality and access get worse and worse. True health care reform.needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

55 of Medtronic's Best Hospital Friends, Including HCA, Settle for $34 Million

The case of the over-marketing of Kyphon's kyphoplasty device (look here ) just got more complicated, and now appears to have involved a...

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