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Over the weekend, the New York Times published a head-turning tale about Dr. Mark Midei, a star cardiologist at St. Joseph Medical Center in Townson, Maryland. According to federal investigators, Dr. Midei implanted potentially dangerous cardiac stents in the arteries of as many as 585 patients who didn’t need them. A hard worker, he managed to knock off those 585 procedures in just two years, from 2007 to 2009. Medicare paid $3.8 million of the $6.6 million charged for the treatments.

The Baltimore Sun broke Dr. Midei’s story in January. In February the U.S. Senate Committee on Finance, which oversees Medicare and Medicaid, began investigating. Monday, the Finance Committee released a 1200-page report.

The report reveals that Midei was a favorite son of Abbott Laboratories, the company that manufactured the stents. Indeed, in August of 2008, Abbott celebrated the fact that the handy doctor had inserted 30 of the company’s cardiac stents into trusting patients in a single day: “Two days later, an Abbott sales representative spent $2,159 to buy a whole, slow-smoked pig, peach cobbler and other fixings for a barbecue dinner at Dr. Midei’s home.”  Employees from St. Joseph’s attended the feast.

Although St. Joseph’s has not admitted to any wrongdoing, last month it agreed to pay a $22 million fine to settle charges that it paid illegal kickbacks to Dr. Midei’s medical practice in exchange for patient referrals. In other words, it seems that the hospital encouraged the doctor to implant those tiny mesh tubes in his patients’ arteries. Certainly, hospital executive knew that they were making handsome profits on Midei’s stent procedures. This is why they paid him those “bonuses” to shepherd unwitting patients to their cath-lab where doctors can diagnose heart attacks, and quickly open arteries. Midei was a rainmaker.

Clinical guidelines generally suggest that an artery be at least 70 percent blocked before a stent is used to open it up, and St. Joseph's rules consider anything less than 50 percent blockage to be “insignificant.”  But court documents allege that some of Midei's patients were told they had blockages in the 90 percent range, while a subsequent review of their records shows blockages closer to 10 percent or less.

             Medical Journals Have Been Telling Us This for Years

But what I find most disturbing is that the story about Dr. Midei is not new; nor is it “news.”  As Dr. Nortin Hadler, author of Worried Sick, argues in his guest-post below, medical research suggests that stents have been overused, nationwide, for years, exposing patients to needless risk and exorbitant expense.

In January of 2006, an article published in the journal Circulation observed that although there has been a dramatic increase in artery-opening procedures in order to prevent heart attacks over the last 10 to 15 years, the rate of heart attacks stayed relatively constant. The findings came from two studies, one done in the U.S. and one done in Canada.

At the time Dr. Thomas Graboys, a professor of medicine at Harvard Medical School, told the Center for Medical Consumers that stents “are virtually useless, in stopping the progress of the disease itself.”  “The public is looking for a magic bullet,” Graboys warned. “Go to a non-hospital-based doctor in the community. A well-trained internist can take care of the lion’s share of people with coronary heart disease. The vast majority of people do well on medication—cholesterol-lowering drugs, antihypertensives, low-dose aspirin.”

For an expert opinion on “the best” and most persuasive of the many studies that raise serious questions about invasive heart procedures, see Dr. Hadler’s post below. 

Nevertheless, as the Center for Medical Consumers reported in 2006: “The number of people undergoing artery-opening procedures continues to rise not only because they are huge money-makers , but they are also very effective at relieving the severe chest pain of angina, which is a common symptom of heart disease.” Patients like the “quick fix” of the stent treatment for angina. Medication doesn’t work as rapidly.

Writing about the Midei case over at Kevin M.D,. Bob Wachter, Professor of Medicine and Chief of the Division of Hospital Medicine at the University of California, San Francisco, comments on the patient response: “Most of his patients were probably quite content – many had chest pain and a stent undoubtedly seemed like an appropriately aggressive, high-tech cure. ‘He put two stents in almost immediately,’ said one grateful patient. ‘I felt relief.’

“Although this patient, 66-year-old Peggy Lambdin, later received a letter indicating that her coronary artery was less than 50 percent blocked (clinically meaningless and not an indication for stenting), she was unfazed,” Wachter observes. “No one can ever tell me that I didn’t need that stent,’ she told the Baltimore Sun. ‘I feel like [Dr. Midei] saved my life.’

“Moreover, I’m guessing that Dr. Midei’s complication rate was quite low,” Wacther continues, “as it usually is when one does procedures on healthy people. He probably followed all the protocols mandated by accreditors and the relevant specialty societies. (Oh yeah, except for the ones regarding professionalism.)

“The problem is this,” he concludes, “as long as the cardiologist reading the cath is the one who pulls the trigger on the intervention, we have a potential Fox/Henhouse problem.”

                                     “Gizmo Idolatry”

What may be most troubling about the Medei imbroglio is that it highlights how our infatuation with high-tech medicine tempts us to ignore medical evidence. The popularity of stents is all part of a mindset that Drs. Bruce Leff and Thomas E. Finucane have termed “gizmo idolatry.” 

Back in June of 2006, a few months before I began HealthBeat, I wrote a post about our use of stents for The Health Care Blog. It was titled: “Tech: Is Newer Better? It’s a Coin Toss.” Below, an excerpt :

 “Last week The Annals of Internal Medicine roiled the medical world by publishing a study suggesting that the drug-coated stents produced by companies like Boston Scientific and J&J may not be quite as miraculous as first advertised. (You will find the abstract here) Following a two-year study, researchers at the Cedars-Sinai Medical Center in Los Angeles are now suggesting that the ‘putative superiority’ of drug-coated stents is founded on questionable premises.’  Or as The Wall Street Journal put it, the clinical trials of drug-coated stents (mostly funded by manufacturers), may ‘have exaggerated their real-life advantage.’ [Dr. Midei was using a new generation of drug-coated stents.]

“Stents, you may remember, are those tiny metal scaffolds that cardiologists use to prop arteries open after they have been cleared of fatty deposits. Since they were approved in the early 1990s, manufacturers have made a fortune peddling the devices which, they say, can prevent a future heart attack while avoiding riskier and more invasive bypass surgery.  Today, stents are used in 85% of all coronary interventions in the United States.

“Before turning to the new Cedars Sinai study, it should be said that THCB has long harbored doubts as to whether these cunning devices represented the best solution for quite so many patients. Back in 2003, THCB quoted a Stanford study which suggested that, over the long term, patients with multi-vessel disease would achieve better outcomes, at a lower cost, if they opted for the bypass operation. In 2005 THCB questioned the cost-effectiveness of the new, improved “drug-coated” stents that are designed to prevent the growth of scar tissue inside the artery. . .

Yet “drug-coated stents have become wildly popular, thanks in part to what The Annals of Internal Medicine describes as ‘aggressive marketing’ and the unbridled expectations of patients. Wall Street likes them too. At $2300 a pop (vs. a mere $700 for the uncoated, bare-metal variety), the newer stents are far more profitable. Despite the hoopla, nine months ago THCB was once again forced to ask ‘Are Stents A Waste of Money?’ after reading about a study of 826 patients, published in Lancet, which suggested that the drug-coated stents made by J&J and Boston Scientific aren't cost-effective for all patients and should be restricted to those at highest risk for heart attack.

“A second 2005 study, published in The New England Journal of Medicine, added to the uncertainty about the widespread use of stents by reporting that patients suffering minor heart attacks do equally well with drug therapy. ‘In a study colliding with established practice, recovery from small heart attacks went just as well when doctors gave cardiac drugs time to work as when they favored quick, vessel-clearing procedures,” the NEJM reported. "The surprising Dutch finding raises questions over how to handle the estimated 1.5 million Americans annually who have small heart attacks – the most common kind. Most previous studies support the aggressive, surgical approach. . . .  Meanwhile, just last fall, Dr. Eric Topol, chairman of the cardiology department at the Cleveland Clinic, warned Consumer Reports: ‘Unfortunately, the extensive use of such stents is far ahead of the data that can be cited to support them.’

 “But it’s not just that manufacturers over-estimated the benefits; they underestimated the new risk that the coated stent introduces. For after reviewing outcomes research, Cedars Sinai’s clinicians found that the drug-coated stents increase the danger that a blood clot will form inside the stent-- months, or even years after the procedure. Such clots can be life-threatening. . .

“The stent story illustrates a major problem in our money-driven health care system. When a product is very profitable, it is promoted to the skies—and, in such cases manufacturers tend to put the very best face on their clinical research. A startling study published last month in the Journal of the American Medical Association comparing clinical trials funded by for-profit entities to clinical trials funded by nonprofit entities underlines the point: it seems that that the industry-funded trials were far more likely to report positive findings.

“Finally, most patients (and even many physicians) tend to assume that, when it comes to medical technologies, ‘newer’ means ‘better.’ This is why, when asked to participate in a randomized clinical trial, some patients refuse, fearing that they will ‘miss out’ on receiving what they assume is the newer, better product. Yet the odds that the bleeding-edge therapy represents an improvement over existing technology are only about 50/50. As Americans we tend to believe in what’s new---as if medical science progressed in a straight linear fashion, one breakthrough after another, from Madame Curie to me. As a result, we pay more—and more—and more—as drug makers and device-makers flood the market with ‘new, improved’ products.”

In Money-Driven Medicine: The Real Reason Health Care Costs so Much, I quote Kaiser Permanente CEO George Halverson who points out that few modern researchers are willing to risk betting their own money on their newest products or procedures. In some cases, he reports, when health care plans have been asked to cover a new, as yet unproven treatment, they have said: ‘Try it. If it works, we’ll pick up the bill. If it fails, then it’s your cost, not ours.’

“Researchers virtually never take the bet because they ‘know that most research fails,’ says Halvorson. “So having their personal incomes tied to the actual success of their unproven care isn’t at all attractive. There is some irony in the fact that the same researchers who enthusiastically extend hope to individual patients are, almost without exception, far too practical about the actual value of their experimental care to risk their own income.”

     ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

I wrote that post in 2006.

Monday, the Times’ story acknowledged that “Prosecutors, malpractice lawyers and state medical boards are only now waking up to the issue . . .The Texas Medical Board last month accused a widely known cardiologist in Austin of inserting unnecessary stents. In September, federal prosecutors accused a cardiologist in Salisbury, Md., of performing unnecessary stent surgeries, and last year a Louisiana doctor was sentenced to 10 years in prison for inserting unneeded stents. . . ”

The Times went on to quote Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic: “What was going on in Baltimore is going on right now in every city in America.” Nissen added that he “routinely treats patients who have been given multiple unneeded stents. We’re spending a fortune as a country on procedures that people don’t need.”

I would love to see the Times expand on these comments by exploring the larger national problem. Ideally, the nation’s paper of record would launch an investigation by looking into the use of stents in its own backyard—Manhattan.

                 Why the Delay in Acting on the Problem?

 Why has it taken so long for state medical boards to “wake up?

I am afraid that many hospitals have resisted the news for one simple reason:  procedures that involve stents are extremely lucrative. In 2007 Business Week told the story of how stents rescued New York’s Mt. Sinai hospital:

“The 2,000-doctor hospital was struggling in March, 2003, when Dr. Kenneth L. Davis took over as chief executive. During the previous six months, Sinai had lost $50 million, partly as the result of tougher caps on Medicare reimbursement rates.  . . . While trimming costs, Davis also decided to build up practices in high-margin specialties. ‘Interventional cardiology was one of myriad areas where we were eager to facilitate growth,’ Davis explains. Dr. Samin Sharma, Mt. Sinai’s “King of Stents,” ran a cath lab which was central to this campaign, performing procedures that typically brought in as much as $20,000 a piece for the hospital.

“Sharma convinced his bosses that to capitalize fully on the stent boom, Mount Sinai should turn his cath lab into a 24/7 operation. At a cost of $400,000 a year, he figured, the hospital could put enough doctors and nurses on call to do emergency angioplasties late at night and on weekends. Soon the lab was averaging 15 off-hours patients a month. Interventional cardiology became a key revenue source for Sinai. By the end of 2006 the hospital's total patient revenues had grown 41%, to $1.2 billion. Cardiology services, excluding surgeries such as heart bypass, contribute 15% of that, most of which comes from Sharma's cath lab.”

This is one of many such stories. Two years ago, a physician at another prestigious Manhattan hospital explained to me why his hospital didn’t offer palliative care: “The COO would rather put the money into expanding the cath lab; it’s far more profitable.”

Let me add that I don’t think that most doctors who recommend procedures using stents are motivated by greed. As Dr. Hadler points out in his guest post, there are many ways for physicians to rationalize their use. Professional pride plays a role: doctors who implant stents firmly believe that they are helping their patients.

Since 2007 Study, Use of Stents Has Dropped, but Many Remain Undaunted

Not everyone has ignored the research. The Baltimore Sun notes that “after a landmark 2007 study in the New England Journal of Medicine concluded that stents were often not beneficial,” enthusiasm waned. “In 2009, Medicare paid ‘just’ $3.5 billion for stent procedures nationwide, down from about $5 billion a year before the 2007 study” was released.  According to the Sun: “The 2007 study didn’t find that stents are worthless, just that not implanting a stent can often be as good — and avoids the real risks of complications or even death from the procedure. But hospitals can’t bill $12,000 for deciding not to implant a stent, even if that’s the best thing for the patient.”

Some physicians remain clearly undeterred by the research.

For example, the Sun reports, "Dr. Midei’s [use of stents] increased, by his own estimate, 50 percent, to about 1,200 a year.” 

As for Mt. Sinai’s Stent star, Cardio Brief, a blog for cardiologists and other cardiovascular health care professionals, heard from Dr. Sharma just last year, shortly after the Brief reported that Columbia University cardiologist Jeffrey Moses had earned  $2.5 million in 2006-7, vaulting him to 8th place in the Chronicle of Higher Education’s Hit Parade of individuals receiving the “highest total compensation at private colleges, 2006- 2007.” Apparently Dr. Sharma was miffed. He got in touch with the blog to point out that “he performs 1,500 complex coronary interventions each year, which apparently is an American record,” Cardio Brief noted. “Sharma also wanted to let us know that the Chronicle's list failed to include Sharma’s own salary of $2.75 million which would have put him ahead of Moses.”

              Health Care Reform Legislation Points to Solutions

Bob Wachter recalls that when the Midei scandal broke, a reporter asked him “Why didn’t peer review catch this?”

Peer review is improving Wachter says, but cases like Dr. Midei’s don’t trip any alarms. Patient who think he saved their lives don’t complain. Still, there are ways stop them.

“Obviously, the Mideis of the world could be caught by requiring that every cath undergo an independent second reading,” Wacther adds. His point is that the physician who diagnoses the need for stents shouldn’t be the one who also performs the procedure. “Some insurers in New Jersey now require such readings before they authorize a stent, and at least one SoCal Kaiser hospital mandates that each cath be presented at a conference before a treatment decision is rendered, analogous to what many tumor boards do for cancers.”

No doubt many of the New Jersey insurers’ customers—and some physicians—object to the requirement. But this is an example of how insurers can add value to health care, not by trying to make treatment decisions themselves, but by calling for more collaboration. If a second doctor must sign off on the reading, this could stop a serial stenter in his tracks. It’s one thing to close your eyes when a colleague is wheeling one patient after another into the cath lab, quite another to associate your name with his activity.

Under health care reform, doctors are more likely to be looking over each others’ shoulders. There will be incentives to join Accountable Care Organizations where doctors or doctors and hospitals work together, and all share in the financial rewards if they are able to avoid waste. Under the Affordable Care Act (ACA) bonuses will encourage doctors to move away from fee-for-service, and toward working on salary (as doctors already do at multi-specialty clinics such as Kaiser or the Mayo Clinic) or accepting “capitated” payments.

In Massachusetts, Blue Cross/Blue Shield, which owns about 45 percent of the private insurance market in the state, already has moved to a combination of capitation and  bonuses for higher quality care. BCBS pays contracting groups of doctors to provide all care, including inpatient services, for its members. The payments are risk-adjusted for age, gender, and health status. Any savings the physicians achieve remain with their group, unless they share the risk with a hospital; in the latter case, part of the savings flow back to the hospital.

Physicians and hospitals also can receive bonuses of as much as 10 percent by doing well on nationally recognized process and outcomes measures. The Massachusetts Blues program is the first major global capitation effort on the East Coast in a decade. Capitation has remained more common the West, where HMO penetration remains greater.

The Centers for Medicare and Medicaid is determined to move away from “fee- for service” payment because we know that inevitably, it leads to more procedures, yet   earlier this year, the Commonwealth Fund reported that “physicians and industry leaders [feel] that cost reductions of 20 percent to 30 percent are achievable under well-constructed global payment models” which pay doctors a lump sum to keep patients well. Meanwhile “patient care suffers in the fee-for-service environment.”  Medicare will not force physicians to give up fee-for-service, but those who cling to being paid “piece work” are less likely to be eligible for the bonuses that reward collaboration and better outcomes.

Under the Affordable Care Act doctors who create a “medical home” also  will be rewarded if they are able to keep their patients healthy and out of the hospital, while avoiding invasive treatments. For heart patients, medication, and diets like Bill Clinton’s “plant diet” are likely to be favored.

In addition, the Medicare Payment Advisory Commission (MedPAC) has suggested that when Medicare spots high volume combined with high profits margins, this is a place to look for overtreatment. The Accountable Care Act allows the Secretary of HHS to lower fees for “overvalued medical services.” One would expect that she will take MedPAC’s advice and that especially in light of the Senate Finance Committee report, as well as legal action in a number of states, procedures involving stents would come under scrutiny.

Finally, as I reported earlier this year, a more proactive Food & Drug Administration has announced that it plans to begin requiring drug makers and device makers to disclose details about their clinical trials—providing detail on their failures as well as their successes. Greater transparency will make it much harder for those who manufacture stents to paint a rosy picture of risks versus benefits—the FDA aims to make sure that these companies are not hiding information about risks.

                          Reform Will Mean More Team Work

Wachter goes on to suggest that team work can also reduce medical errors—including overtreatment. Many at the hospital must have known what Midei was doing, he suggests, but looked the other way. “Cardiologists don’t perform caths on desert islands – they are assisted by cath techs and nurses.  In my experience, these folks become as adept at reading cath films as any physician. If the allegations against Midei are true, it strains credibility to think that no one in the lab knew that inconsequential lesions were being read as tight stenoses and treated with stents.

“And what about hospital administrators?” he asks. “While it is possible that no St. Joe’s leader knew precisely what was happening, I’m guessing that some did but chose to look the other way: the pressure to steer clear of the golden-egg-laying goose must have been intense. Perhaps the fact that the hospital’s CEO and two other senior executives resigned after the case broke provides a clue as to who knew what when.

“Cases like this one are terribly troubling,” he continues, “not just because they harm individual patients but because they do violence to the trust that is so fundamental to the physician-patient relationship.

“But these cases also force us to consider the kind of culture that could allow such a fraud to take root and go on for years – a culture that likely prized the hospitals’ and physicians’ financial health over the clinical health of their patients. If the allegations are true, the penalties should be severe, not only for Dr. Midei but also for leaders who knew – or should have known – what was going on, yet remained silent.”

Under reform, “accountability” is likely to extend beyond the individual patient-doctor relationship. Physicians and hospitals that work together—and are paid as a team—will become accountable for each other.

Read More: http://www.healthbeatblog.com/2010/12/stent-scandal-a-shocking-story-but-not-news-.html