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Overuse of Cardiac Stents Linked to Patient Deaths

Courtesy of USA Today ( June 20, 2013)
News Medical Industrial Complex Recommended Links Indications and counter-indications for cardiac stents How Much Does an Angioplasty Cost?   Health insurance
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When the same cardiologist diagnose the problem prescribe the procedure and does the surgery the potential for abuse is enormous. Around 300K unnecessary stent are inserted annually in the USA. This is a big business and you should ne aware that they want money, and do not actually care much about your health.  Health care industry (aka medical industrial complex)  that seems to be driven by the quantity of procedures, rather than the quality of patient care. Number of cardiologists sentenced to jail terms in the USA is counted in dozens. And they are just the tip of the iceberg -- neoliberal perversion of health care. Making profit motive central.

Profit motives is the primary driver ("greed is good") for many medical practices, who abandon Hippocratic oath. Among one of the notable types of abuse is cardiac stenting (which is a mass practice in the USA). Per-conditions for inserting the sent are fuzzy. Insurance companies do not require the proof that arteries are clogged using independent diagnostic method. So greed dominated  (and cost insurance companies and Medicare a lot of money).

Especially abhorrent is behaviour of some cardiologists who abuse patient who get into emergency with completely different problem (say arrhythmia). 

this is the area where control of of "proper preconditions" is very difficult as the same doctor recommends the procedure and later does the surgery. no one requres consilium in non-acute cases. Which encourages corruption. 

When you’re a hammer everything looks like a nail.


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[Jan 04, 2017] Study suggests route to improve artery repair

Notable quotes:
"... People with any form of diabetes are at greater risk of developing cardiovascular conditions than people without the disease. Moreover, if they undergo an operation to open up a clogged artery by inserting a "stent" surgical tube, the artery is much more likely to clog up again. ..."
"... Surgical stents for artery repair are typically coated with slow-releasing drugs that aim to suppress excessive regrowth of the surrounding smooth muscle cells. This approach to release drugs locally might work for drugs that boost SHP-1 expression, King speculates. ..."
Jan 04, 2017 | www.eurekalert.org
BOSTON - (January 4, 2017) - People with any form of diabetes are at greater risk of developing cardiovascular conditions than people without the disease. Moreover, if they undergo an operation to open up a clogged artery by inserting a "stent" surgical tube, the artery is much more likely to clog up again.

However, researchers at Joslin Diabetes Centers now have uncovered an explanation for why these procedures often fail, which may lead toward better alternatives.

An enzyme known as SHP-1, which can suppress the growth of smooth muscle cells lining the inside of blood vessels, plays a crucial role in stent failure, says George King, M.D., Joslin's Chief Scientific Officer and senior author on a paper in the journal Diabetologia describing the work.

Stents coated with a drug that activates SHP-1, and thus slows the accelerated growth of these vascular cells, might help in treating arterial disease in diabetes, says King, who is also Professor of Medicine at Harvard Medical School.

His team's research began with experiments among mice fed a high-fat diet and rats that were genetically modified to display insulin resistance and related metabolic conditions related to diabetes. "We found that SHP-1 expression was decreased in the arteries from all of these animal models," says Weier (Glorian) Qi, co-lead author on the paper. "We also found that SHP-1 expression dropped in the arteries of patients with type 2 diabetes."

Next, the scientists created mice that were genetically engineered to over-express the protein in their vascular smooth muscle cells. When the scientists fed these mice a high-fat diet that clogged their arteries and performed a procedure similar to stent insertion, they found that the arteries in these animals were less clogged than in normal mice given the same procedure.

The researchers went on to demonstrate that SHP-1 is reduced in mouse vascular smooth muscle cells primarily by the high levels of lipids in the blood associated with diabetes and related conditions, rather than the high levels of glucose also present in those conditions.

Following up on these findings may help to address a major research puzzle in diabetic complications, says King: Each type of tissue seems to react differently to the disease.

For example, he explains, smooth muscle cells grow thicker in large blood vessels like arteries, but similar type of contractile cells begin to die off in tiny blood vessels in the eye.

"These opposite cell growth patterns are an enigma," King comments. "They also make it difficult to develop therapeutics, because we would want to deactivate SHP-1 in the eye and activate it in large arteries."

Surgical stents for artery repair are typically coated with slow-releasing drugs that aim to suppress excessive regrowth of the surrounding smooth muscle cells. This approach to release drugs locally might work for drugs that boost SHP-1 expression, King speculates.

"We hope our research encourages ideas about how to address this problem for people with diabetes," he adds. ""The more ideas that come up, the greater the chances that we can achieve such a needed treatment."

Joslin's Qian Li1 was the other co-lead author on the paper. Joslin contributors also included Christian Rask-Madsen, Samuel Lockhart, Yu Xia, Xuanchun Wang and Mogher Khamaisi. Chong Wee Liew of the University of Illinois at Chicago; Lars Melholt Rasmussen of Odense University Hospital in Odense, Denmark; and Kevin Croce of Brigham and Women's Hospital also were co-authors. Lead research support came from the JDRF, the American Diabetes Association and the National Institute of Diabetes and Digestive and Kidney Diseases.

[Dec 04, 2016] The goal of the majority of providers is to increase total sales by ordering many procedures and or drugs that are not needed. Much of this is done from ignorance and is not necessarily indicative of a purely capitalistic motive.

Notable quotes:
"... The goal of the majority of providers is to increase total "sales" by ordering many procedures and or drugs that are not needed. Much of this is done from ignorance and is not necessarily indicative of a purely capitalistic motive. ..."
www.amazon.com
Dwight Clark on May 1, 2013
An author that really knows and understands the complexities of the healthcare (sickcare) industry

I was a practicing cardiologist in the US for over 30 years. I, as most other practicing cardiologist, was trained and fully believed the prevailing methods of diagnosis and treatment were not only correct but absolutely necessary. Several decades of experience taught me this is not close to being accurate. The majority of medical tests, and much of the treatment, is not only unnecessary, but harmful and/or dangerous. The goal of the majority of providers is to increase total "sales" by ordering many procedures and or drugs that are not needed. Much of this is done from ignorance and is not necessarily indicative of a purely capitalistic motive.

David Goldhill is one of the few authors that have experienced this travesty and is educated and intelligent enough to understand the consequences of this nationwide epidemic and the needless, wasteful, and dangerous care. His ability to sort through all of the "noise" prevalent in the governmental and media diatribe and isolate the real problem as full insurance for everyone is unique. This system is doomed for failure. There will never be enough resources to fund medical care as long as the consumer is not the payer. They will always demand more and the providers are happy to accommodate them.

I have left the US and am presently living in Beijing, China, attempting to establish purely preventive heartcare clinics. This is more general education regarding diet, smoking, sedentary lifestyle, and alcohol abuse. than traditional western medicine. Less income, but certainly more satisfying.

[Dec 04, 2016] Overuse of Cardiac Stents Linked to Patient Deaths

About a third of all cardiac stents implanted in patients are unnecessary, says cardiologist David Brown of Stony Brook University School of Medicine
Notable quotes:
"... About a third of all cardiac stents implanted in patients are unnecessary, says cardiologist David Brown of Stony Brook University School of Medicine. That amounts to more than 200,000 stents a year, and controversy surrounding this practice has spurred nationwide litigation and a federal investigation into several cases involving illegal kickbacks and allegations of cardiac stent malpractice. ..."
"... Blood clots can occasionally form in an inserted stent, which can then lead to the artery narrowing once again. In some cases, the blood vessel can become completely blocked – a condition called in-stent thrombosis. ..."
"... Most patients that undergo stenting are prescribed blood thinners in the wake of the procedure to ensure such events don't occur. ..."
"... Cardiac stents are big business for hospitals and their staff, with the average private insurance reimbursement for a procedure totaling $25,000. By placing a stent inside an artery, surgeons can restore blood flow that has been compromised in heart attack patients, or give help to patients at risk for future heart attack. But when misused or overused in patients, cardiac stents can prove fatal, as they did for former postal service worker Bruce Peterson. ..."
"... Peterson developed several blood clots and blockages due to his weakened heart, which ultimately caused his untimely demise, argues his widow Shirlee Peterson. ..."
"... Nortin Hadler, a UNC Chapel Hill professor of medicine told Bloomberg News, "Stenting belongs to one of the bleakest chapters in the history of Western medicine. Cardiologists "are marching on" because "the interventional cardiology industry has a cash flow comparable to the GDP of many countries" and doesn't want to sacrifice the revenue, he said. ..."
medstak.com

About a third of all cardiac stents implanted in patients are unnecessary, says cardiologist David Brown of Stony Brook University School of Medicine. That amounts to more than 200,000 stents a year, and controversy surrounding this practice has spurred nationwide litigation and a federal investigation into several cases involving illegal kickbacks and allegations of cardiac stent malpractice.

For the most part, stenting procedures are relatively low in risk and moderately safe. However, as with any surgical procedure – even a minimally invasive one – there is a risk of developing complications. Blood clots can occasionally form in an inserted stent, which can then lead to the artery narrowing once again. In some cases, the blood vessel can become completely blocked – a condition called in-stent thrombosis.

Most patients that undergo stenting are prescribed blood thinners in the wake of the procedure to ensure such events don't occur.

Additionally, manipulating arteries with a stent or any other sort of medical procedure can lead to the walls of the blood vessel becoming injured or damaged. The innermost layer of coronary arteries, known as the endothelium, is particularly susceptible to this sort of damage; the result can be the formation of scar tissue in the area of the stent, and this too can lead to the artery re-narrowing in a process known as restenosis. Treating Restenosis can involve an additional stenting procedure, though in severe cases where a stented artery recloses it may be necessary to have a patient undergo a coronary artery bypass to remedy the condition.

Overuse of cardiac stents leads to patient deaths

Cardiac stents are big business for hospitals and their staff, with the average private insurance reimbursement for a procedure totaling $25,000. By placing a stent inside an artery, surgeons can restore blood flow that has been compromised in heart attack patients, or give help to patients at risk for future heart attack. But when misused or overused in patients, cardiac stents can prove fatal, as they did for former postal service worker Bruce Peterson.

After suffering chest pain, Peterson paid a visit to cardiologist Dr. Samuel DeMaio, who inserted 21 stents in his patient's chest over a period of eight months, including five mesh tubes in a single artery. Peterson developed several blood clots and blockages due to his weakened heart, which ultimately caused his untimely demise, argues his widow Shirlee Peterson.

She later sued DeMaio for cardiac stent malpractice – an increasingly common charge in a Dr. Darshan P. Godkar, MD - Cedar Knolls, NJ - Cardiology & Interventional Cardiology & Internal Medicine Healthgrades.comqaDr. Darshan P. Godkar, MD - Cedar Knolls, NJ - Cardiology & Interventional Cardiology & Internal Medicine Healthgrades.com

Nortin Hadler, a UNC Chapel Hill professor of medicine told Bloomberg News, "Stenting belongs to one of the bleakest chapters in the history of Western medicine. Cardiologists "are marching on" because "the interventional cardiology industry has a cash flow comparable to the GDP of many countries" and doesn't want to sacrifice the revenue, he said.

Cardiac stent problems cost $2.4 billion a year

The U.S. health care system spends an estimated $2.4 billion a year caring for patients that received unnecessary cardiac stents, says Dr. Sanjay Kaul, of Cedars-Sinai Medical Center. Patients face a much greater risk for complications like coronary scar tissue, blood clots and uncontrolled bleeding from anticoagulant medications – all of which can be life-threatening. Jim Simecek told Bloomberg that he is on blood-thinning medicine for the rest of his life to prevent clots in the cardiac stents he received from a Cleveland doctor who is currently the subject of a federal probe.

Sixty-four year old Monica Crabtree's cardiac stent problems caused a torn artery, which resulted in an infection and her death, according to her husband. He also pursued legal action after it was determined by another cardiologist that Monica's stent was completely needless. The surviving spouse recovered $240,000 in a malpractice settlement brought against the surgeon.

FDA reports hundreds of deaths attributed to cardiac stents

Some 773 patient deaths linked with cardiac stents were logged with the FDA last year, according to Bloomberg. Though this figure has jumped more than 70 percent since 2008, with recent media coverage on cardiac stent overuse and ongoing federal investigations, cardiologists may be using fewer stents and only on suitable patients.

John Harold, president of the American College of Cardiology said the doctors who have been charged with cardiac stent malpractice or fraud are essentially "outliers" in their community, and that these surgeons fail to represent the "overwhelming majority."

[Oct 14, 2016] Deaths Linked to Cardiac Stents Rise as Overuse Seen

Notable quotes:
"... Jashu Patel, an interventionalist in Jackson, Michigan, billed $2.7 million for procedures in 2007, according to a U.S. Justice Department case against him settled in July. (He is no relation to Mehmood Patel). ..."
"... The suit alleged Patel implanted needless stents in at least two patients, including one that led to a blood clot that killed an unnamed woman who had reported no symptoms of reduced cardiac blood supply. A stress test showed normal blood flow, and notes in her file said she didn't want interventions, said Julie Kovach, a cardiologist who worked with Patel and brought the case to the government's attention. ..."
"... "It was appalling," Kovach said in an interview. "Patel coerced her into getting a stent she didn't need, which killed her." ..."
"... "I do believe that Bruce was a guinea pig," she said. "That was the way it was done." ..."
Bloomberg

When Bruce Peterson left the U.S. Postal Service after 24 years delivering mail, he started a travel agency. It was his dream career, his wife Shirlee said.

Then he went to see cardiologist Samuel DeMaio for chest pain. DeMaio put 21 coronary stents in Peterson's chest over eight months, and in one procedure tore a blood vessel and placed five of the metal-mesh tubes in a single artery, the Texas Medical Board staff said in a complaint. Unneeded stents weakened Peterson's heart and exposed him to complications including clots, blockages "and ultimately his death," the complaint said.

DeMaio paid $10,000 and agreed to two years' oversight to settle the complaint over Peterson and other patients in 2011. He said his treatment didn't contribute to Peterson's death.

"We've learned a lot since Bruce died," Shirlee Peterson said. "Too many stents can kill you."

Peterson's case is part of the expanding impact of U.S. medicine's binge on cardiac stents -- implants used to prop open the arteries of 7 million Americans in the last decade at a cost of more than $110 billion.

When stents are used to restore blood flow in heart attack patients, few dispute they are beneficial. These and other acute cases account for about half of the 700,000 stent procedures in the U.S. annually.

Among the other half -- elective-surgery patients in stable condition -- overuse, death, injury and fraud have accompanied the devices' use as a go-to treatment, according to thousands of pages of court documents and regulatory filings, interviews with 37 cardiologists and 33 heart patients or their survivors, and more than a dozen medical studies.

'Marching On'

These sources point to stent practices that underscore the waste and patient vulnerability in a U.S. health care system that rewards doctors based on volume of procedures rather than quality of care. Cardiologists get paid less than $250 to talk to patients about stents' risks and alternative measures, and an average of four times that fee for putting in a stent.

"Stenting belongs to one of the bleakest chapters in the history of Western medicine," said Nortin Hadler, a professor of medicine at the University of North Carolina at Chapel Hill. Cardiologists "are marching on" because "the interventional cardiology industry has a cash flow comparable to the GDP of many countries" and doesn't want to lose it, he said.

Stenting abuse is by no means the norm, but neither is it a rarity. Federal cases have extended from regional medical centers in Louisiana, Kentucky and Georgia to a top-ranked metropolitan hospital system in Ohio.

Asset Seizure

A doctor practicing at a hospital owned by the Cleveland Clinic, rated the premier heart center in the country by U.S. News and World Report, had his assets seized by federal agents in a stent investigation, according to federal court filings in April. The Clinic has not been accused of wrongdoing, and says it's cooperating with the investigation.

Two out of three elective stents, or more than 200,000 procedures a year, are unnecessary, according to David Brown, a cardiologist at Stony Brook University School of Medicine in New York. That works out to about a third of all stents.

Brown said his estimate is based on eight clinical trials of 7,000 patients in the last decade, which he analyzed in the Archives of Internal Medicine last year. Two cardiology researchers who have studied the use of stents say the number could be as low as about half Brown's estimate, and one said it is probably larger.

Costs, Risks

Even the low end of these estimates translates into more than a million Americans in the past decade with implants in their coronary arteries they didn't need, said William Boden, chief of medicine at a Veterans Administration hospital in Albany, New York. Boden was the principal investigator of a 2007 study known as Courage that found stents added no benefit over medicines, exercise and dietary changes in stable patients.

Unnecessary stents cost the U.S. health care system $2.4 billion a year, according to Sanjay Kaul, a cardiologist and researcher at Cedars-Sinai Medical Center in Los Angeles. Patients who received them are living with risks including blood clots, bleeding from anti-clotting medicine and blockages from coronary scar tissue, any of which can be fatal, Kaul said.

Monica Crabtree died at age 64 after one of her arteries was torn in a stent procedure that led to infection, according to her widower, Gary Crabtree. He received at least $240,000 from a 2011 settlement of his lawsuit against her doctor, after a second cardiologist reviewed the case and told him the stent wasn't needed. Crabtree choked up speaking about his late wife and showed pictures of their 47 years together.

Worried Shaving

"It wasn't just a simple mistake," said the retired auto worker in Largo, Florida. "If the stent was something she really needed, I could have handled it. But it was a total loss of life that didn't need to happen."

Jim Simecek, of Medina, Ohio, said he worries every morning that a nick from shaving could bleed out of control. Simecek, who works at a Ford dealership, said he has to take blood-thinning medicine for life to ward off clots in the six stents he received from a Cleveland-area cardiologist who's under federal investigation for his stent work.

"It's as if your heart was open and somebody was sticking a knife in," said Rhonda McClure, 54, referring to eight stents she received from a Kentucky cardiologist who agreed in June to plead guilty to a federal Medicaid-fraud charge for falsifying records used to justify a stent he placed.

Patient Letters

Cardiac stents were linked to at least 773 deaths in incident reports to the U.S. Food and Drug Administration last year, according to a review by Bloomberg News. That was 71 percent higher than the number found in the FDA's public files for 2008. The 4,135 non-fatal stent injuries reported to the FDA last year -- including perforated arteries, blood clots and other incidents -- were 33 percent higher than 2008 levels.

The FDA declined to comment on whether the reports were a cause for concern. It said adverse-event reports tied to medical devices have increased overall due to agency efforts. It also said the data can contain incomplete and unverified accounts from reporting parties.

More than 1,500 patients have gotten letters from hospitals since 2010 alerting them that their stents may have been unnecessary. In Philadelphia, the University of Pennsylvania Health System sent 700 such notices in April.

Stenting Decline

At least 11 hospitals have settled federal allegations of charging for needless stenting and other misdeeds in the catheterization labs where the procedures are performed. Federal probes of stenting practices continue in at least five states. In Louisiana and Maryland, cardiologists went to federal prison last year for implanting the devices and charging for them without medical justification. A third doctor has agreed to do time in a plea bargain.

"There is a huge financial incentive to increase the number of these procedures," said Jamie Bennett, a former assistant U.S. Attorney in Baltimore who handled stent investigations. "The cases we have seen to date are just the tip of the iceberg."

Since Boden's Courage study, stenting procedures have declined by about 20 percent. Still, this July, a panel of experts convened by the American Medical Association and the Joint Commission, a hospital accreditor, named elective stenting as one of five overused treatments that too often "provide zero or negligible benefit to patients, potentially exposing them to the risk of harm."

Better Choices

Doctors are using fewer stents and choosing more-appropriate patients than they were a few years ago, according to John Harold, president of the American College of Cardiology, the specialty's main professional group. Harold said that "real-world clinical practice" and research indicates Brown probably overestimated how many people with coronary artery disease could be handled initially only with drug-based treatment.

He said there are examples of inappropriate use and the ACC is taking steps to "address and correct the imbalance" with treatment guidelines and by urging more hospital oversight. Cardiologists who've been accused of fraud or are serving prison time are "outliers" who don't represent the "overwhelming majority."

Lawyers for John McLean, a Salisbury, Maryland, cardiologist convicted of billing for unwarranted stenting, argued in a federal appeal last year that inappropriate usage is widespread and their client was prosecuted for behavior that's the industry norm.

Lost Appeal

They cited a 2011 study in the Journal of the American Medical Association that found only half of elective stent procedures nationally were appropriate under usage guidelines written by societies of heart specialists. The study found 12 percent were inappropriate, and 38 percent fell into the uncertain category of the guidelines.

"The study demonstrated clearly that a large number of stable patients receive coronary artery stents that are later found to be inappropriate or questionable," the appeal argued. "The same was true of the patients in Dr. McLean's practice." McLean's appeal was denied in April. He is serving an eight-year sentence.

Elective-stent patients typically see rapid quality-of-life improvements, including in their ability to work and be active, according to Ted Bass, president of the Society for Cardiovascular Angiography and Interventions, whose members specialize in cardiac implants. The Courage trial found stents, compared to medication and lifestyle changes, were better at relieving chest pain for as long as two years after placement -- a benefit that ended by 36 months.

Profit Centers

First used in Europe in 1986, cardiac stents took off in the 2000s as cardiologists found them to be more effective in heart attacks than angioplasty. In that earlier technology, a small balloon is inflated to widen blood passages and then withdrawn. Stenting facilities, known as "cath labs," spread at hospitals and became profit centers.

Hospitals receive an average payment of about $25,000 per stent case from private insurers, according to Healthcare Blue Book, a website that tracks reimbursements. The federal Medicare program pays less. Doctors who implant stents earn a separate fee that averages about $1,000 and ranges from $500 to $2,850, according to Medicare and Blue Book data.

The procedure typically involves inserting the stent with a catheter through a small incision in the groin area or wrist and snaking it through to heart vessels. It usually takes less than 45 minutes.

Kickbacks Alleged

Stony Brook's Brown, and Boden, who led the Courage study, argue that many elective patients should be getting medical therapy before they risk stents. Only 44 percent try medication and lifestyle changes before stenting, a 2011 study in the Journal of the American Medical Association found.

At least five hospitals have reached settlements with the Justice Department over allegations that they paid illegal kickbacks to doctors for patient referrals to their cath labs. St. Joseph Medical Center in Towson, Maryland, paid the government $22 million without admitting liability.

Prosecutors alleged the hospital paid kickbacks to a practice co-founded by Baltimore cardiologist Mark Midei for stent referrals. His doctor's license was revoked in 2011 when the Maryland Board of Physicians found he falsified records to justify unwarranted stents.

St. Joseph told 585 of its patients they may have received unnecessary stents. In May, 252 patients reached a settlement with the hospital under confidential terms, according to Jay D. Miller, an attorney for the plaintiffs.

Plea Agreement

The hospital settled the government's case "to avoid the expense and uncertainty of litigation," it said in a statement. Spokeswoman Julia Sutherland said the hospital declined to comment on any patient lawsuits.

In an interview, Midei denied he stented without medical need. He took issue with experts who deemed many of his stents needless, and said disagreement among cardiologists on cases is common. Midei was not a party to the federal settlement. The government has said its investigation of the case continues.

In June, Sandesh Patil, a cardiologist practicing at another St. Joseph hospital -- this one in London, Kentucky -- agreed to plead guilty to charging Medicaid for a stent that wasn't medically warranted under the program's rules. (Although both hospitals were once owned by the same parent, the one in Maryland has been sold.)

Catheterization procedures multiplied at St. Joseph in London after Patil began practicing there in 2000, when the hospital had a different name. In that year, the type of procedure used for stents was done 210 times. They climbed to 929 by 2009, state data show.

Multiple Stents

Stenting income from Medicare alone was more than a sixth of the hospital's 2009 operating income, based on data from American Hospital Directory, a research firm. When Patil left London in 2010, catheterization procedures fell 34 percent from their 2009 high. Using the midpoint of the directory's price range for such procedures, the decline would have cost the hospital about $15 million. David McArthur, the hospital's spokesman, declined to comment on its revenues.

Rhonda McClure, one of Patil's patients, had her arteries catheterized 18 times by him and his partners over four years, according to her deposition and other filings in a lawsuit she and 361 other patients have brought against Patil, St. Joseph and other doctors who practiced there. She said she received eight cardiac stents. The defendants deny the negligence and fraud allegations against them.

McClure's deposition says a cardiologist who reviewed her case after the stents told her that scarring caused by "too many procedures" was her main problem.

Short Breath

McClure said she suffers from chest pain and shortness of breath, and has been told by her new doctor that she may need more stents and surgery to keep her coronary arteries from closing. She said she gets so tired she needs to sit and rest after walking down the stairs.

St. Joseph-London repaid Medicare $256,800 for unnecessary procedures and is cooperating with federal prosecutors, McArthur said. He said Patil was never employed by St. Joseph and lost his privileges to practice there in December 2010. Patil's attorney said his client had no comment.

Under his plea bargain, Patil agreed to serve 30 to 37 months in federal prison. He forfeited his Kentucky medical license for five years. In 2012, he told a family court judge his monthly income was $53,300.

"Thirty-seven months is nothing for all the injuries he done for money," McClure said.

Message Balancing

After the Courage trial shed doubt on stents' effectiveness for stable patients, stent-implanting cardiologists felt unfairly attacked and organized a campaign to "better balance the messaging," said Bonnie Weiner, who was president of the Society for Cardiovascular Angiography and Interventions at the time.

The society hired a public relations firm and paid it more than $300,000 a year to help publicize the benefits of stents, according to the group's filings with the Internal Revenue Service. The firm helped launch a consumer website for SCAI, SecondsCount.org, which has published several articles, including one under the headline, "For many patients, open arteries are better than closed arteries."

SCAI collected $2.7 million in donations for "public education" between 2008 and 2011 from stent makers Abbott Laboratories Inc., Boston Scientific Corp., Cordis Corp. and Medtronic Inc., its Web site says. Manufacturers' sales of cardiac stents were about $5.5 billion globally last year, down 5 percent from 2011, according to the Health Research International consulting firm.

High Median

Medtronic spokesman Joseph McGrath said grants to SCAI for patient education are "unrestricted," and SCAI is solely responsible for how the funds are used. Spokesmen for Abbott, Boston Scientific and Cordis declined to comment.

Interventional cardiologists, the specialty SCAI represents, earn a median income of $562,855 a year, as compared to $207,117 for family doctors, according to Medical Group Management Association, which surveys physician practices. The interventionalists ranked 13th among 118 specialties tracked by MGMA.

Michigan Death

Mehmood Patel, a Lafayette, Louisiana, cardiologist who went to prison last year on 51 counts of charging for needless stents, made over $16 million in one three-year span, evidence in the case showed. Prosecutors said he was driven by the desire to be the busiest cardiologist in town.

He unsuccessfully argued that he used his best medical judgment in every case and lost an appeal. Patel is serving a 10-year sentence in a federal penitentiary.

Jashu Patel, an interventionalist in Jackson, Michigan, billed $2.7 million for procedures in 2007, according to a U.S. Justice Department case against him settled in July. (He is no relation to Mehmood Patel).

The suit alleged Patel implanted needless stents in at least two patients, including one that led to a blood clot that killed an unnamed woman who had reported no symptoms of reduced cardiac blood supply. A stress test showed normal blood flow, and notes in her file said she didn't want interventions, said Julie Kovach, a cardiologist who worked with Patel and brought the case to the government's attention.

"It was appalling," Kovach said in an interview. "Patel coerced her into getting a stent she didn't need, which killed her."

False Claims

Kovach said that when she told the chief operating officer of the hospital where Patel worked about the death, the executive, Karen Chaprnka, diverted the conversation. Reached recently by e-mail through a hospital spokesman, Chaprnka said she "disagreed with the allegations made by Dr. Kovach."

"He's their cash cow," said Kovach, now co-director of a clinic that treats congenital heart disease at the Detroit Medical Center. "They're not about to turn him in."

Patel and the hospital, Allegiance Health, agreed to pay the U.S. a total of $4 million to settle the federal charges. Kovach was awarded $760,000 as a whistle-blower under the U.S. False Claims Act. Allegiance disagreed with the allegations and settled the claims to avoid "lengthy litigation," it said in a statement.

Patel continues to practice at the hospital and must improve record-keeping to substantiate cardiology procedures, Allegiance said. In the settlement, Patel agreed to hire a consultant to oversee treatment of his patients and an auditing firm to monitor billings. He didn't return phone messages.

Cleveland Raid

In Ohio, Simecek, the worker at the Ford dealership, grew suspicious after his sixth stent from cardiologist Harry Persaud at the Cleveland Clinic's Fairview Hospital in 2011. Simecek said he went for a second opinion and was told he didn't need any of the stents. Now he said he has to take blood thinners the rest of his life.

"With the littlest cut, the blood starts running," said Simecek. "What if I am in an auto accident?"

Persaud is under criminal investigation for health care fraud, mail fraud and money laundering, according to federal court filings. Last October, Federal Bureau of Investigation agents raided his office and removed financial records and patient files for procedures at three Cleveland-area hospitals. The government has seized $343,634 from his and his wife's bank accounts, alleging the funds represent the proceeds of fraud related to a "significant number" of unnecessary stent procedures.

Multiple, Elongated

The Cleveland Clinic found "problems related to the use of stents in some patients" at Fairview and reported them to the government, according to spokeswoman Eileen Sheil. She would not say how many patients were affected. Persaud resigned from the hospital staff last year.

At least 64 of Persaud's patients at St. John Medical Center in suburban Westlake received letters from the hospital saying they may have received an unnecessary stent between 2010 and 2012, according to spokesman Patrick Garmone, who said Persaud no longer practices there.

Persaud denied wrongdoing in court filings and said his stent procedures were proper. Neil Freund, his attorney in lawsuits filed by patients alleging unwarranted stents, said "it is our intent to defend these cases." He had no comment on the federal investigation.

Final Order

In Texas, the state medical board's final order in DeMaio's case found that the cardiologist placed "multiple, elongated, overlapping" stents in patients in areas of "insignificant or only moderate disease." Peterson, the retired mailman, was identified only as Patient C in the staff complaint. No patient was mentioned in the final order.

Peterson was thriving in his new career in the travel business, his wife Shirlee said. He had a heart attack in 1997, which didn't crimp his love of travel and dance, she said. "He was an awesome man who never met a stranger," she said.

After his death, Shirlee Peterson said a friend told her she had a cardiologist who refused to do multiple stents.

"I do believe that Bruce was a guinea pig," she said. "That was the way it was done."

DeMaio said Peterson was extremely sick when he came to him. He said it was significant that the board's final order didn't use the word "excessive" in describing his stent work. That included 31 stents stretching for 14 inches inside the arteries of Patient B in the staff complaint.

"Any patient of mine who received a full metal jacket" -- interventional cardiology's term for such extensive work -- "would have been turned down by at least one, if not multiple surgeons," DeMaio said. He said he doesn't use stents as much these days because standards have changed and he doesn't see as many seriously ill patients.

[Oct 09, 2016] Data Also Shows Increased Stent Thrombosis for Bare Metal Stents

Data Also Shows Increased Stent Thrombosis for Bare Metal Stents
Oct 09, 2016 | ptca.org

DAPT Study Extended Treatment After Stenting Lowers Stent Thrombosis and Heart Attacks

"Longer is better."

That's what Dr. Dean Kereiakis told Angioplasty.Org when characterizing the results of the long-awaited Dual Antiplatelet Therapy (DAPT) study, which were presented today at the annual American Heart Association Scientific Sessions in Chicago.

Dr. Kereiakes is the co-principal investigator for this five year study of 10,000 patients, which adds to the knowledge base of whether long-term treatment with aspirin and a thienopyridine, such as Plavix, after stent implantation is beneficial to patients.

[Oct 09, 2016] Do You Really Need a Stent for CAD

Apr 13, 2016 | www.verywell.com
Reviewed by a board-certified physician. Updated We have all heard the claims that cardiologists are inserting too many stents in patients with coronary artery disease (CAD) . And the fact is that this happens much more often than we would like to think.

So what should you do if your doctor says you need a stent? Are you one of those people who actually do need a stent - or should your doctor be talking to you about medical therapy instead?

If your doctor tells you that you need a stent, it is likely he or she will attempt to explain why. But the issue can be quite complicated, and your doctor may not be entirely clear in his/her explanation. And you may be too stunned by the news that you need a stent to concentrate completely on what you are being told.

Fortunately, if your doctor says you need a stent, there are three simple questions you can ask which will tell you what you really need to know. If you ask these three questions, you stand a much better chance of getting a stent only if you really need one.

Question One: Am I Having A Heart Attack?

If you are in the early stages of an acute heart attack, the immediate insertion of a stent can stop the damage to your heart muscle, and can help reduce your chances of suffering cardiac disability or death. If the answer to this question is "yes," then a stent is a very good idea.

No need to go on to Question Two.

Question Two: Do I Have Unstable Angina?

Unstable angina , like an actual heart attack, is a form of acute coronary syndrome (ACS) - and therefore it should be considered a medical emergency. The early insertion of a stent can stabilize the ruptured plaque that is producing the emergency, and can improve your outcome.

If the answer to this question is "yes," placing a stent is most likely the right thing to do. No need to go on to Question Three.

Question Three: Isn't There Medical Therapy I Can Try First?

If you get to Question Three, it means that you are not having an acute heart attack or unstable angina. In other words, it means you have stable CAD. So, at the very least, placing a stent is not something that needs to be done right away. You have time to think about it, and to consider your options.

It is the patients with stable CAD who, according to the best clinical evidence available, are receiving far too many stents. In stable CAD, stents turn out to be very good at relieving angina , but they do not prevent heart attacks or reduce the risk of cardiac death. So, the only really good reason to insert stents in people with stable CAD is to relieve persistent angina when aggressive treatment with medication fails to do so.

The Best Approach For Stable CAD

The best treatment for people with stable CAD is to take every step that is available to stabilize plaques in the coronary arteries -- that is, to keep the plaques from rupturing.

(It is the rupture of a plaque that produces ACS in the first place).

Stabilizing plaques requires the control of cholesterol , blood pressure , and inflammation, no smoking , regular exercise, and making clotting less likely. Aggressive drug therapy will include aspirin , statins , beta blockers , and blood pressure medication (when necessary). If you are having angina, adding nitrates , calcium channel blockers , and/or ranolazine will usually control the symptoms.

If your angina persists despite this kind of aggressive medical therapy, then by all means a stent is something that should be strongly considered. But keep in mind that a stent only treats one particular plaque, and that most people with CAD have several plaques. Furthermore, while most of these plaques are considered "insignificant" by traditional measures (since they are not producing much blockage in the artery), it now appears that the majority of cases of ACS occur when one of these "insignificant" plaques suddenly ruptures.

What this means is that, whether or not you end up getting a stent for your stable CAD, you still will need aggressive medical therapy to prevent the rupture of one of those "other" plaques, the "insignificant" ones, the ones for which too many cardiologists may express little or no interest.

Summary

If you are told you need a stent, you can quickly determine how badly you need one, if at all, by asking three simple questions. These questions are so easy for your doctor to answer - generally with a simple yes or no - that there will be no excuse for his/her failing to take them up with you.

But if it turns out that you have stable CAD, and therefore a stent is at least not an emergency, you are owed a full discussion about all your treatment options before you are pressured into a stent.

[Oct 09, 2016] Unnecessary stents costing millions

Notable quotes:
"... MJA ..."
"... The Finance Committee reportedly found that Abbott Laboratories, which manufactures stents, had long been in the practice of rewarding Dr Midei financially for being a high-volume user of its stents. ..."
"... "Stenting in stable angina is open to debate in some circumstances as to whether it reduces mortality but every study done shows it is effective in relieving symptoms," he said. ..."
"... New England Journal of Medicine ..."
"... Journal of the American College of Cardiology ..."
"... There is also another interesting dynamic operating here. In the days when the cardiologists did "medical therapy" and the Cardiothoracic surgeons did bypass procedures, the cardiologists were the gatekeepers to the surgical therapy, referring on those who had failed medical therapy. The dynamics have now changed with interventional cardiology – there is no gatekeeper to interventional therapy – cardiologists self-refer for intervention – procedures from which they derive considerable profit. It would be difficult to argue that this has had no influence on the stent rate. ..."
"... As an interventionist, I unfortunately know of at least one cardiologist who stents clearly non-significant disease a la Dr Midei. He doesn't "believe" in FFR or MIBI scans! It is very hard to prove though. ..."
Oct 09, 2016 | doctorportal.com.au
13 December 2010 MJA InSight

UP TO one-third of coronary stents inserted in patients with stable coronary artery disease (CAD) in Australia each year ― about 3500 stents - may be unnecessary, potentially harmful and costing the nation millions of dollars, according to a leading cardiologist.

Professor Richard Harper, emeritus director of cardiology at MonashHeart, Monash Medical Centre in Melbourne, said any experienced interventional cardiologist would admit that many coronary lesions with 50‒70% stenosis were being stented in Australia without certain knowledge that the particular lesion was causing ischaemia.

Medicare statistics show that, last year, there were 22 383 operations for insertion of a stent or stents in Australia (20 780 in 2008 and 21 204 in 2007), for which Medicare paid $6.78 million ($6.24 million in 2008 and $6.2 million in 2007).

These payments do not include the cost of a coronary angiography, radiological services and preparation, or aftercare.

The average cost of coronary angiography with stent insertion, including hospital stay, is $18 300 of which Medicare pays $1647.

Professor Harper said about 50% or more of stents were inserted in stable CAD patients and the remainder were in patients with acute heart attack, for which stenting was almost always warranted.

A rapid online publication of a detailed paper written by Professor Harper on the use of stents in CAD patients has been published by the MJA .

He was commenting after the issue of unnecessary stenting hit the headlines in the United States, with the revelation that Baltimore cardiologist Dr Mark Midei may have implanted 585 stents that were medically unnecessary from 2007 to 2009.

An article in theheart.org , the website for cardiovascular health professionals, said a US Senate Finance Committee report called the Midei imbroglio "a clear example of potential fraud, waste, and abuse". (1)

The Finance Committee reportedly found that Abbott Laboratories, which manufactures stents, had long been in the practice of rewarding Dr Midei financially for being a high-volume user of its stents.

However, many US cardiologists believe Dr Midei is being treated unfairly.

The Cardiac Society of Australia and New Zealand (CSANZ)'s Interventional Council chair, Associate Professor Andrew MacIsaac, said any fraud or criminal behaviour by a cardiologist, as was being alleged in the US, was appalling and would be totally unacceptable.

However, he had never heard of it occurring in Australia and it was different from doctors having a diversity of opinion over the appropriate indications for coronary stenting.

"Stenting in stable angina is open to debate in some circumstances as to whether it reduces mortality but every study done shows it is effective in relieving symptoms," he said.

Professor Harper said the problem with what he considers to be unnecessary stents in Australia "lies in our system of reimbursement for coronary procedures".

He said patients often had more than one coronary lesion and the only sure way to tell which one was the cause of the myocardial ischaemia was by measuring fractional flow reserve (FFR) - or the effect of the narrowing on blood flow - during coronary angiography.

However, FFR was not commonly undertaken in Australia because the flow wire was costly and not adequately reimbursed in either the public or private system.

The procedure was also fiddly, took time and resulted in fewer stent insertions - a procedure which attracted a much higher fee.

"Faced with a 50-70% coronary stenosis, it is easier and more remunerative for an interventional cardiologist to stent the lesion rather than measure FFR - particularly when there is a two-thirds likelihood that the result will show no need for the stent," Professor Harper said.

Medicare statistics show that, last year, only 385 procedures for FFR were carried out in Australia (234 in 2008 and 131 in 2007).

Professor Harper said the health system should be restructured to make it more financially viable to measure FFR.

He said a pivotal randomised study in the New England Journal of Medicine last year, of 1000 patients with multi-vessel coronary artery disease, showed that routine measurement of FFR in patients undergoing percutaneous coronary intervention with drug-eluting stents significantly reduced the rate of death, non-fatal myocardial infarction and repeat revascularisation compared with patients who had stents inserted on the basis of angiography alone. (2)

The patients who underwent FFR had fewer stents implanted at a lower cost.

The results were replicated in a follow-up study at two years, which was reported in the Journal of the American College of Cardiology . (3)

Professor MacIsaac said CSANZ had been lobbying for more than 10 years for the establishment of a national registry of coronary interventions to audit outcomes and quality assurance.

However, it was still waiting for federal and state funding.

"A database has essentially been prepared but there is no funding mechanism to implement the collection or analysis of the data," he said.

"If we really want to be assured that everything is fine, that would be the way to go."

A Medicare spokeswoman said the unnecessary insertion of cardiac stents had not been identified as a specific compliance issue.

"However, health professionals should be aware that when Medicare Australia has a concern that items are being claimed without meeting the item requirements, an audit may be conducted," she said.

Medicare Australia treated all allegations of non-compliance seriously and encouraged anyone who suspected potential fraud or non-compliance under the Medicare program to call the Australian Government Services Fraud Tip-off Line on 131 524.

  1. Sue says: December 14, 2010 at 11:52 am

    There is also another interesting dynamic operating here. In the days when the cardiologists did "medical therapy" and the Cardiothoracic surgeons did bypass procedures, the cardiologists were the gatekeepers to the surgical therapy, referring on those who had failed medical therapy. The dynamics have now changed with interventional cardiology – there is no gatekeeper to interventional therapy – cardiologists self-refer for intervention – procedures from which they derive considerable profit. It would be difficult to argue that this has had no influence on the stent rate.

  2. Rick says: December 14, 2010 at 5:45 pm

    Very interesting and informative article with some good comments – need more like this.

    • – Highlights a long-standing major problem with Medicare failing to keep up with technology, but would interventionalists change their habits if Medicare changed? In the public sector the Medicare rebate usually doesn't matter; in private they'll charge (and should charge) what they feel is the appropriate fee. What is needed is proper peer review and clinical governance in both sectors.
    • – Probably highlights the need for better funding of cognitive work compared to intervention.
    • – As far as MIBI scans go, not all labs are equal. If I can, I get mine done in hospital labs with regular through-put where they regularly correlate results with angiography.
    • – Predictable response from the Medicare bureaucrat, but not understanding the issue at all (nothing to do with fraud, and everything to do with delivering a better outcome more cheaply).
  3. Stewart mair says: December 15, 2010 at 9:49 am

    Myocardial perfusion studies are well reimbursed and are an arm's length procedure. It is also rumoured that stress echo, not an arm's length procedure, works.

  4. Stenter says: December 15, 2010 at 12:50 pm

    The emperor has no clothes!

    As an interventionist, I unfortunately know of at least one cardiologist who stents clearly non-significant disease a la Dr Midei. He doesn't "believe" in FFR or MIBI scans! It is very hard to prove though.

  5. Brett Forge says: December 15, 2010 at 11:56 pm

    The article makes some very important and quite radical points about diagnosis and assessment of chest pain and atherosclerosis.

    But they then assert that in patients with ischaemia, revascularisation improves outcomes, and that patients with significant ischaemia should have invasive angiography.

    This is unproven. All the randomised trials of stable angina show that revascularisation may reduce short term angina but does not reduce mortality or myocardial infarction rates.

    If they want to reduce the cost and wastage in modern cardiology just restrict PCI to those patients in whom angina is limiting or in whom an adequate trial of medical therapy has failed to control symptoms.
    This will reduce the numbers of interventions by far more than 30%.
    If and when FFR measurements are shown to reduce mortality or AMI then the conclusions of this article will be evidence based. At the moment they are not.
    Whilst many procedures are beneficial to patients, vast numbers of procedures are performed on patients in whom no proven long-term benefit has been demonstrated.
    Has there been a greater racket in the history of medicine?

  6. Anonymous says: December 19, 2010 at 2:45 am

    Hasn't MIBI scanning been providing this info for the past 20 years already?
    It's arms length and much more reliable than stress echoes.

  7. Rick says: December 19, 2010 at 8:53 pm

    The MJA article also states that stenting non-ischaemic lesions (ie with normal FFR) worsens the prognosis. This is of concern.
    The article also suggests abolishing the item number for MIBIs and using CT coronary angios to diagnose CAD – not sure that this is a viable option for patients with significant renal failure or even in areas where CT coronary angio is relatively new; seems like an exclusively teaching hospital perspective.

  8. Surgeon says: January 17, 2011 at 9:23 pm

    And this overuse does not cover the large number of patients having multiple stents and ending up with a definitive operation some time and multiple infarcts later

  9. prof Montage says: January 18, 2011 at 8:42 pm

    I was late to look at this dialogue.
    Brett Forge has it spot-on.
    He usually does!

  10. john langdon says: November 12, 2012 at 3:17 pm

    John.
    This is happening in australia now. Have 3 drug eluting stents fitted with no tests prior,same niggles of exertional pain continued at start of exersise then dissapeared for duration of 1.5 hours bike ride after stents.niggles of chest pain lasted approx 4 months after stenting. Never breathless/overweight/or smoked,very athletic. Father 100 years old no cardiac history. Have had conformation of my angiogram confirmed that there were no restrictions by leading USA medical institution, that needed intervention. Qld cardiologist also falsified his files, where do I go now?.

[Oct 09, 2016] Many Stent Procedures Unnecessary

Mar 26, 2007 | www.webmd.com

Hundreds of thousands of Americans may undergo unnecessary angioplasty and stent procedures to open clogged heart arteries each year, a landmark study suggests.

The long-awaited results show that people with stable coronary artery disease who got common medications to lower blood pressure and cholesterol levels were no more likely to die or to have a heart attack over the next five years than those who also underwent angioplasty with stents .

Of the more than 1.2 million angioplasty procedures performed each year, at least 50% of them are done on an elective basis in people with stable coronary artery disease, says Stephen Nissen, MD, president of the American College of Cardiology (ACC) and head of cardiovascular medicine at The Cleveland Clinic.

In people with coronary artery disease, plaque builds up in the arteries, making it harder for blood to get through, thereby depriving the heart muscle of oxygen. This can lead to chronic chest pain that worsens during exercise and to heart attacks .

During angioplasty, a balloon at the end of a long tube is threaded through an artery in the groin. The doctor shimmies the probe up through the patient's leg and into the arteries of the heart, inflating the tiny balloon at the spot where the vessel has narrowed.

To keep the vessel open, doctors usually add a stent to the end of the balloon catheter. These metal, mesh-like tubes prop open clogged arteries to restore blood flow.

Angioplasty Still Best for Some

The study's results do not apply to people who get stents because they are in the midst of a heart attack or whose chest pain suddenly gets worse, doctors stress. For them, angioplasty is a proven lifesaver.

Additionally, angioplasty is better at relieving the chest pain associated with angina , says researcher William Boden, MD, of Buffalo General Hospital/Kaleida Health in Buffalo, N.Y.

"For an individual patient, angioplasty may still be the best option," he tells WebMD. "But there has been an implication that if you give patients drug therapy rather than angioplasty, you're giving them less than optimal treatment.

"Now we know that if you opt for medicine, you are not putting patients at risk," Boden says.

The study, known as COURAGE, was released at the annual meeting of the American College of Cardiology and simultaneously published online by The New England Journal of Medicine .

Stent Patients as Likely to Die, Have Heart Attack

The researchers studied 2,287 people with stable coronary artery disease who experienced chest pain for about two years, with an average of 10 episodes per week. All had at least a 70% blockage in one or more heart arteries.

All participants were put on optimal drug therapy, which includes nitroglycerin to control chest pain, beta-blockers to control heart rate , ACE inhibitors for lowering blood pressure, and statins to lower cholesterol . Everyone was also urged to exercise more and lose weight and quit smoking , if needed.

Then, about half the participants also underwent angioplasty, usually with stents.

Over the next five years, 19% of those in both groups died or had a heart attack. Similar numbers of people in both groups -- about 12% -- were hospitalized for heart problems.

However, there were some benefits to angioplasty. People who had the procedure were 40% less likely to need another procedure to open up blocked heart arteries. And, particularly in the first two years, they reported better quality of life and less frequent episodes of chest pain.

But over time, some of the differences started to dissipate. By five years later, 74% of people who had angioplasty were angina-free vs. 72% of those who got drugs alone, a difference so small it could be due to chance.

Results Stun Medical Community

Boden notes that COURAGE is "the first properly-sized study to answer the question of whether angioplasty and stents reduce the risk of death and heart attacks in people with stable coronary artery disease."

The results came as a shock to many in the cardiology community -- even to the researchers themselves.

"The study was designed with the hypothesis that the combination of angioplasty and optimal medical therapy would be superior," Boden says. "But the results do not support its benefit in reducing heart attacks and death when used as an initial management strategy."

So why would so many doctors recommend a costly procedure without strong evidence it works?

The average cost of having an angioplasty was $38,000 in 2003, according to the American Heart Association.

Nissen thinks it's because "it seems so intuitively obvious: If you open up a block artery, you'll fix the problem."

American Heart Association President Raymond J. Gibbons, MD, chief of cardiology at the Mayo Clinic, adds that there's a financial incentive for doctors. "People get paid for how many procedures they do," he tells WebMD.

But this study "clearly shows there is no advantage to PCI [percutaneous coronary intervention, or angioplasty] as an initial strategy. It's unnecessary," Gibbons says. "Angioplasty should be reserved for patients [who can't be helped] by medical therapy."

Adds Nissen, "This study will change a lot of thinking. The benefits of angioplasty in people with stable chest pain is very modest, at most. It should be reserved for patients for intolerable symptoms."

Results Questioned

But many doctors who perform angioplasties say the procedure's proven benefits in relieving angina, or chest pain, is getting lost in the shuffle.

Donald Baim, MD, chief medical officer of Boston Scientific, a manufacturer of drug-eluting stents, says, "COURAGE is not a catastrophic failure. [It shows that angioplasty plus stents] improves symptoms."

Marty Leon, MD, of Columbia University Medical Center, says, "There are so many deep flaws in the way this study was executed and planned. It was rigged to fail," and it did. "This study should not affect treatment patterns."

Boden says the criticism is unfounded, pointing out that the researchers purposely studied people at medium to high risk of having a heart attack or dying -- "the very people you would expect to benefit most from the procedure."

[Oct 09, 2016] Medicares second highest-paying doc performed unnecessary heart procedures

Notable quotes:
"... Last year, the DOJ joined two whistleblower lawsuits against Asad Qamar, who owned the Institute of Cardiovascular Excellence in Ocala, Florida. The lawsuits alleged that he regularly billed for unnecessary procedures and violated the Anti-Kickback Statute by waiving Medicare copayments. ..."
"... Months later, the Centers for Medicare & Medicaid Services banned Qamar from the Medicare program ..."
"... Qamar was Medicare's second-highest paid physician in 2012, earning $18.3 million. In 2013, he made $16 million, more than seven times the amount received by the next highest earning Florida cardiologist, according to data collected by ProPublica. ..."
"... Unnecessary cardiology procedures have been a focal point for government investigators over the last year, and some have questioned whether Medicare's fee-for-service model incentivizes unnecessary surgeries. ..."
Jul 05, 2016 | www.insurancefraud.org
, Washington, DC - One of the country's highest paid physicians agreed to a three-year exclusion to settle claims that he billed Medicare for medically unnecessary cardiac procedures, according to the Department of Justice.

Last year, the DOJ joined two whistleblower lawsuits against Asad Qamar, who owned the Institute of Cardiovascular Excellence in Ocala, Florida. The lawsuits alleged that he regularly billed for unnecessary procedures and violated the Anti-Kickback Statute by waiving Medicare copayments.

Months later, the Centers for Medicare & Medicaid Services banned Qamar from the Medicare program , prompting support from a Super PAC of former patients who were "disgusted and distressed" by the government's portrayal of Qamar.

In addition to a three-year exclusion from Medicare, Qamar will pay $2 million and forgo an additional $5.3 million in suspended claims.

Qamar was Medicare's second-highest paid physician in 2012, earning $18.3 million. In 2013, he made $16 million, more than seven times the amount received by the next highest earning Florida cardiologist, according to data collected by ProPublica.

Unnecessary cardiology procedures have been a focal point for government investigators over the last year, and some have questioned whether Medicare's fee-for-service model incentivizes unnecessary surgeries.

Source: Fierce Healthcare

[Oct 09, 2016] Stent Scandal A Shocking Story, But Not News Health Beat by Maggie Mahar

Oct 09, 2016 | www.healthbeatblog.com
Posted on December 8, 2010 by Maggie Mahar 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.

NG on December 8, 2010 at 12:49 pm said:
You go to jail for assualt, correct?? Reply ↓

Maggie Mahar on December 8, 2010 at 1:56 pm said:
Yes, but physicians rarely go to jail for malpractice.
Even in Redding, California, where a doctor performed hundreds of unnecessary bypasses and angioplasties, he did not go to prison.
Part of the problem is that in these cases, the doctor may well have thought that he was helping the patients.
The physician himself becomes part of a mass cultural delusion about the efficacy of certain procedures. People are thanking and congratulating him– patients, their relatives, the hospital, etc.
He may well believe he is saving lives.
Though of course there are extreme cases where a doctor is consciously over-treating, but I suspect those are very rare. Reply ↓

jim jaffe on December 8, 2010 at 4:14 pm said:
whilst I'm enthusiastic about CMS moving toward capitation, I'm not holding my breath. In the meantime, simply releasing payment information would help the press and public target such excess, as the WSJ piece on prostate care indicates. Reply ↓

VA Loan income on December 8, 2010 at 4:37 pm said:
@ NG medical malpractice is not assault. Furthermore, I believe you mean battery. Reply ↓

Pat S on December 8, 2010 at 4:47 pm said:
NG –
Just to clarify –
As long as a doctor has obtained a signed consent, they are pretty much immune from assault charges, unless of course they engage in sexual or other illegal activity with a patient. As Maggie says, doctors who engage in inappropriate care are guilty of malpractice, a violation of contract (civil) law, not criminal law.
If it can be demonstrated that a doctor was willfully negligent or engaged in fraudulent behavior, many, perhaps most, malpractice policies have clauses that obsolve the insurance company of responsibility, potentially leaving the doctor responsible for the entire cost of settlement or judgements themselves. In practice, this is rarely invoked except in cases involving falsifying records after the fact, perjury, and other similar things, but in theory it could be in some cases. Court findings of fraud or willful negligence also expose the doctor to potential punitive financial damages, in addition to the usual compensatory damages. Malpractice insurance generally does not cover punitive damages.
In addition, of course, doctors are subject to investigation and censure by their hospitals, potentially leading to loss of privileges (the right to work in the hospital) or other lesser sanctions, and by state medical boards, potentially leading to loss of license or other lesser sanctions.
Finally, if there is a finding that a doctor willfully or fraudulantly billed for false charges to Medicare, Medicaid, or private insurance, the doctor would be liable for a judgement of insurance or Medicare fraud. That can result in criminal charges and in permanent or temporary loss of the right to bill Medicare for services. Reply ↓

Maggie Mahar on December 8, 2010 at 4:54 pm said:
VA–
You are correct-you if you make physical contact with your victim, that's battery.
But doctors can go to jail for malpractice–typically if they are found guilty of fraud and malpractice.
A doctor who knowingly performs unnecessary surgery– or hospializes patients who don't need to be hospitalized– is bilking the insurer while harming the patient, and can go to jail.
Intent is very important.
Of course very, very, very few doctors ever intend to harm a patient. But some do set out to over-charge insurers, Medicare or Medicaid, and sometimes the patient suffers the "collateral damage."
I'm not an attorney, so I don't know whether a prosectuor has
to prove intent, or whether there are cases where criminal negligence could put a doctor in jail.
Ordinarily, though doctors are not imprisoned for malprctice because society acknowledges that we all are human and even the very best doctors make mistakes. Reply ↓

Barry Carol on December 9, 2010 at 9:54 am said:
Maggie,
I have a different take on this.
First, my own experience goes like this. I had quintuple bypass surgery in 1999. I was told that I probably had a small heart attack sometime in the past and never realized it as there was some minor heart damage. I was put on maximum medical therapy after the surgery and have been on it ever since. I take a beta blocker, an ACE inhibitor, a statin, an anti-spasmodic drug and a blood thinner plus baby aspirin. After six years, an angiogram following new complaints of chest pain found one artery that was 85% blocked and a stent was inserted on the spot which took only an incremental 15 minutes or so beyond the time for the angiogram by itself. While I occasionally have some chest pain from time to time, it's minor and the medical regimen continues and will continue indefinitely.
I was glad to get the stent at the time of the angiogram rather than have to come back for a separate procedure. If a second doctor had to sign off to confirm the need for one or more stents, it would delay treatment and add to the patient's anxiety. If the first and second doctor each worked for the hospital with their compensation tied, at least in part, to the hospital's revenue and profit, I'm skeptical how many times the first interventional cardiologist would be overruled.
Instead, when payers, including commercial payers as well as Medicare and Medicaid notice that a particular doctor and/or hospital is performing an unusually large number of procedures of any type, timely unannounced post-procedure audits should be performed by experts hired and paid for by the payers. If clearly unnecessary procedures are being done, especially when claiming that a blockage is much greater than the film shows it to be, the consequences for the doctor should be swift and severe including prosecution for fraud and, possibly, loss of his medical license. If hospital compliance departments want to perform their own audits as well, more power to them.
With regard to the studies that claim to show that there is no benefit from stents regarding either life expectancy or preventing future heart attacks or strokes, they don't speak to the quality of life implications of reduced chest discomfort. Chest discomfort, especially if it occurs at rest and not during or shortly after eating is not only stressful, it can be perceived as life threatening. By contrast, pain from, say, arthritis, is both annoying and can negatively affect quality of life, but it's not life threatening. That's a huge difference to those of us who live with heart disease.
Finally, the new reform driven approach to pay hospitals modest bonuses if they meet certain quality standards is not likely to be as effective as you think or imply. Hospitals that don't do procedures don't get paid. For capitation or bundled payments to work, they would need probably to be assured of total revenue equal or at least close to what they are generating today. For most hospitals, 60% of their costs are fixed and 40% are variable. It's not that easy for them to reduce costs in the short term.
As an aside, I recently met with the CEO, who is also a physician (OBGYN), of a large hospital system in the NYC metropolitan area and the CFO of a well known hospital system in Pennsylvania. Both said that they could not make money if they had to take Medicare rates from all comers even if there were no uncompensated care. Reply ↓

Pat S on December 9, 2010 at 5:41 pm said:
Barry –
Your story is a good example of why anecdotal results don't mean much.
It is true that people with angina often get faster relief from stents than medical treatment, but it is also true that medical treatment is usually successful at providing relief from angina after a short interval, an interval that can usually be bridged successfully with use of morphine and nitrates. On the other side of the coin, stent patients have much higher incidence of problems related to stent failure, re-stenosis, and delayed stent complications, plus face the risk of acute complications, including death, during the procedure.
In fact, in most stent patients the stent most likely is responsible for the pain effects for only a fairly short time, at which point the maximal medical therapy they are almost always on as well takes over and carries most if not all of the weight.
Studies still do suggest that stenting is the preferred treatment in either acute heart attacks or in unstable angina, but the studies are very convincing, as shown elsewhere on this and the related thread, in showing that there is no real advantage and most likely a slight disadvantage to managing both standard angina and non-symptomatic coronary artery disease with stents instead of medical therapy alone. Reply ↓

Maggie Mahar on December 9, 2010 at 9:02 pm said:
Barry–
]
The research shows that
stent procedures offer relief from the pain of angina for a while–but not forever.
It's fast, but a band-aid fix.
Drugs and a change of diet
can help the patient for a much longer period of time.
And as Pat S. points out in his comment, pain-relieving drugs can help patients until the other medications kick in.
As for whether hospitals can make money on Medicare-or lowered Medicare payments– sse the Medicare Payment Advisory Commission report which I have referenced in the past showing that
most hospitals do turn a profit on most Meidcare patients.
As for hospital CEOs at overpaid hospitals in NYC and PIttsburgh who tell you they couldn't surive on Medicare paymtents? (I'm pretty sure I know the hospitals you are referring to) What did you think these CEO's would say?

As for Medicare paying hospitals less: this will begin quite soon. Medicare will be penalizing hospitalis with excessive readmissions, and, each year, they will be cutting annual increases to all hospitals by 1%.

Medicare wants to put hospitals under some fianncial pressure because MedPAC reserach shows that when hospitals are under financial pressure, they learn to become more efficient–and, in fact, beginning making a profit on those Medicare reimbursements.

As Pat S. points out, in his comment, anecdotes (or stories you hear from people with an ane to grind) are one thing; MedPAC's well-documented analysis is another.
These CEOs are making 7-figure salaries as a reward for running a hospital as a revenue center (as opposed to a patient-care center).Of course they will say that the government isn't paying hospitals enough.
Pat S.
Yes–tand hank you.
But in your last paragraph I think you mean "but the studies are NOT very effective" ???
If so, let me know, and I can go in and make the fix. Reply ↓

Barry Carol on December 10, 2010 at 5:30 am said:
Pat –
Do you have any data on the percentage of stent placements that go into patients who are either asymptomatic or have stable angina? I don't understand why and under what circumstances asymptomatic patients would ever be sent to the cath lab in the first place. Conversely, I also wonder how many patients who receive stents would have been better off for the longer term with a CABG.
Maggie –
The PA hospital system is based in Philadelphia, not Pittsburgh. The CFO said their current margin on their Medicare business overall ranges from 0 to -10%. They make decent money on the surgical procedures but the medical admissions, as a group, are more problematic from a financial standpoint. He also said that in the two years prior to this year, their costs per adjusted admission grew 3.5% with the comparable number for this year at 2.0%. Meanwhile, Medicaid pays them less than 70% of their costs with more payment reductions coming due to state fiscal pressures. If Medicare payments rise only 1% or so while their costs continue to go up at 2%, it's a formula for continued cost shifting to commercial insurers.
The main area where all hospitals have the potential to get better is in reducing 30 day readmission rates and they are all working on that. ACO's certainly have the potential to do a better job with care coordination, especially if decent electronic records are in place and used. The trend toward more hospital employed physicians makes it easier to consolidate vendors and standardize operating room protocols. At the same time, they could lead to even greater concentration of market power which could result in healthcare costs even greater than they would have been under fee for service even with global payments, bundled payments for surgical procedures or partial capitation.
The powerful hospitals will vigorously resist value based insurance design though BCBS of Massachusetts is moving ahead with the introduction of a tiered in network insurance product on January 1, 2011. While I strongly support that approach, I suspect that, in the end, we may well wind up with an all payer system but Medicare and, especially, Medicaid will have to pay more than they do now. That's a heavy lift in the current fiscal environment. Reply ↓

Maggie Mahar on December 11, 2010 at 12:34 am said:
Barry–

As you know, a profit margin turns on the cost of operations.

MedPAC has found that the cost of operations at a great many hospitals is much, much higher than it needs to be. This is because they are terribly inefficient.

Just one example: they have three or four ORs that are all very busy during the morning and more or less empty in the afternoon.
This is because many surgeons prefer to operate in the morning, and if these surgeons bring in business, hospital administrators do their best to please them.
These hospitals need only two ORs.

As for hospitals having greater market power as physicians and hospitals consolidate, the government pays more and more hospital bills, "the makket" is not going to determine prices. Government (taxpayers) already pays more than 50% of all health care bills in the U.S.

Going forward, govt's share will grow (as more people age into Medicare, and as as Medicaid and SCHIP expand).
Note what happened this year when the Secretary of HHHS negotiated with Medicare Advantage insurers on prices: next year, premiums will be 1% lower than they were this year, and Sebelius insisted that they slash co-pays for extremely expensive drugs for cancer, MS, etc.

In other words, government is beginning to regulate prices. (Medicare Advantage insures will be pushing back, refusing to overpay drugmakers, hospitals, etc.)

The Affordable Care ACt also cuts increases in payment to hospitals and nursing homes by 1% a year–every year. This provision is designed to put pressure on hospitals to become more efficient.

As MedPAC research show, when hospitals are under some financial pressure, they find a way to cut waste in what it costs them to deliver care. Reply ↓

Maggie Mahar on December 11, 2010 at 12:40 am said:
Barry–
Pat didn't say that "asymptomiatic patients" undergo stent procedures.

He said that patients suffering from angina–who have never had heart attacks- undergo these procedures.

This is true.

And, research shown that while angioplasty with stents offers them quick relief from pain, over the long term, their angins often comes back.

Medication and change of diet, on the other hand, is much more likley to lead to long-term relief from angina.

More imporantly, when patients undergo angioplasty with stents, long-term repeated reserach shows that their chances of suffering a heart attack–or dying from a haert attack– are NOT REDUCED.. Reply ↓

Pat S on December 11, 2010 at 6:45 pm said:
Barry –
Non-symptomatic patients end up in cath lab because of results of other tests - ecg, stress ecg, nuclear cardiology, lab tests, and these days especially coronary artery CT. These tests are advocated as screening tests and are obtained for things like clearance to begin exercise programs, "executive" physicals, family history or other risk factors, or just plain general prinicples. When they have positive findings, the logical next step is to send the patient to cath. Part of this is pure overkill, and part of it is due to some physicians' desire to locate patients with the so-called "widowmaker" lesion - significant stenosis in the left main coronary artery - before they suffer severe or life threatening events.

The result goes: screening suggested for one reason or another > abnormal results in screeing > cath > abnormal cath findings > stenting. It is a good example of the problem of accidentally creating disease by the doctor boxing themselves in with testing that was not needed in the first place.
I have no idea of what the percentages of people who are non-symptomatic who end up getting stents, but simple angina is the most common cause of heart cath and stenting in many centers.

I personally once had a stress ecg - clear back when I was in my late 40′s - as a screening test at the urging of my doctor despite being asymptomatic at the time. Fortunately, it was negative and everything ended there. Reply ↓

Pat S on December 11, 2010 at 6:58 pm said:
Maggie –
Actually, I did say that asymptomatic patients undergo cath and stenting, under the circumstances that I outlined in my answer to Barry. The problem is that some, probably many or most, cardiologists believe that once they discover what they consider to be a significant stenosis they more or less HAVE to treat it to prevent it from causing the patient problems down the road.

As to the sentence: it may be awkward because of the parenthetical phrase, but what it says, minus the aside, is:
"the studies are very convincing in showing that there is NO real advantage and most likely a slight disadvantage to managing both standard angina and non-symptomatic coronary artery disease with stents instead of medical therapy alone."
(caps added to "no" for empnasis.) Reply ↓

Barry Carol on December 11, 2010 at 8:29 pm said:
Pat –
Thanks for the explanation of how non-symptomatic patients wind up in a cath lab. It makes perfect sense. In my own case in 2005, there were some symptoms and a stress test showed a significant adverse change from my prior stress test a year or so earlier.
I understand that stent placement is a lucrative procedure for both the hospital and the interventional cardiologist. I wonder, though, what role defensive medicine plays in the equation as compared to how decisions about how to treat screening test findings are determined in other countries. I could see where formula based protocols might be developed here that would call for a stent if the percent blockage is above X depending on where it is – maybe a lower threshold for the Left Main or, perhaps, the LAD as compared to one of the distal branches. Even if the interventional cardiologist knows that the patient has stable angina or is non-symptomatic, if the percent blockage is above the threshold, and he doesn't put a stent in, what if the patient has a heart attack in the next week / month / year? The path of least resistance in our litigious culture is to insert the stent. Oh, and by the way, it pays well too. If the docs in other countries perceive, correctly, that, as a practical matter, they are unlikely to ever be sued, even if the screening results are positive, the patient may not be sent to the cath lab if he/she is non-symptomatic or has stable angina. My sense is that defensive medicine may be an important part of the equation that determines interventional cardiologists' practice patterns in the U.S. even though its effect cannot be specifically determined or quantified. Reply ↓

run75441 on December 11, 2010 at 10:34 pm said:
"This is pretty much what happened in one notorious case,that of Shasta Regional Medical Center in the small town ofRedding, California. There, two rogue cardiologists, Chae Hyun Moon and Fidel Realyvasquez Jr., headed a team that performed extraordinary volumes of unnecessary and recklessly dangerous heart operations. In the end, both would lose their licenses, and each would pay a $1.4 million fine in lieu of federal criminal prosecution. Yet for years before, their building reputations as top-notch cardiologists brought in patients from all over Northern California. In gratitude, the hospital pampered them with department chairmanships and perks. Dr. Moon even enjoyed occasional use of the hopital's emergency helicopter to fly to golf tournaments.

Our Lady of Lourdes Regional Medical Center in Lafayette, Louisiana, provides another example of how high-volume rogue surgeons can escape scrutiny for years, either because hospital administrators don't know, or profit from pretending not to know, how dangerous they are. At Lourdes, there were rumors for years that one of its surgeons, a Dr. Mehmood Patel, was performing vast amounts of unnecessary heart operations. Yet it wasn't until one of Patel's fellow doctors at last secretly sued him in federal court under a special whistleblower law that the hospital revoked his admitting privileges. The hospital subsequently agreed to pay a fine of $3.8 million but still denies it had any way of knowing about the safety or effectiveness of Dr. Patel's care.

As the number of specialists in a community grows, many people cut out visits to their primary care physicians altogether. Instead, they skip from one specialist to another according to what body part gives them reason to complain that day, all the while gathering more and more bottles for the medicine cabinet." Phillip Longman "Best Care Anywhere" Reply ↓

Maggie Mahar on December 12, 2010 at 7:41 pm said:
run 75441-
Yes, the Redding story eptiomizes what has been happening.
I interviewed some of the victims of Redding when I wrote Money-Driven Medicne. Very sad stories.
And I do blame the hospitals. While looking at overtreatment, Dartmouth researchers realized that Redding was doing an extraordinary number of bypasses and angioplasties. Dartmouth helped expose the problem.
Dartmouth is on the ohter side of the country. Administrators at the California hospital should have realizled that something unusual was going on. Reply ↓

Pat S on December 13, 2010 at 6:41 pm said:
Barry –
This is the usual complicated stew of motives for performing tests and procedures that are not scientifically warranted. The main issue, in truth, is probably that the doctors believes that they are doing the right thing, based on their grasp of the science and their personal feelings about what they are doing, possibly influenced by personally not having kept up on the science and by the continued insistence of academic doctors with career stakes and of reps from supply, equipment, and drug companies that the evidence against the procedures are flawed, incomplete, or don't apply to a brilliant person like themselves who gets far better results than the people at institutions where the research is done .

It is very very hard for doctors to admit to themselves that something they have been doing for a while is now demonstrated to be of little value or even potentially harmful. The rest of the complicated motives behind this, ranging from the desire of their hospitals to keep expensive equipment paying for itself to personal prestige to the financial rewards to the feeling that if they don't do something they might be sued all enter into the mix, but the first is the main thing.

The interesting thing is that the article in the Times suggests that the tide has turned and that doctors are actually at greater risk of litigation from DOING the procedure than from NOT DOING it. This is relatively unusual in medical circles, although there have been some spectacular cases of litigation for performing a procedure that is useless or causes harm. The most spectacular was the case of retrolental fibroplasia causing blindness in infants who had been given too high of levels of oxygen in intensive care nurseries, usually because of prematurity. A small group of unfortunate pediatricians who had been somewhat behind the curve on the issue ended up being sued by the children when they reached adulthood, 18 to 21 years later. In many cases, the malpractice insurance that was in force for the incidents had been acquired two decades earlier and had cash limits that were way too low for the settlements and judgements that were being given, leaving the pediatricians, many of whom had already retired, to pay 7 figure awards out of their own pockets. That lesson influenced a lot of doctors from my generation, who saw all this happen early in our careers, but lessons that don't quite fit with personal ego and ambition have a tendency to be forgotten after a while, especially by younger people who did not see the events first hand. Reply ↓

Barry Carol on December 14, 2010 at 10:09 am said:
Pat –
Thanks for the very thorough and nuanced explanation. It makes a lot of sense as usual. I think it's encouraging that doctors may be starting to perceive greater litigation risk from doing this procedure as opposed to not doing it. In the meantime, with modern data analytics, I think both public and private payers could more aggressively audit some of these cases to confirm medical necessity, especially when they notice unusually large numbers of procedures being performed by a given institution or a specific physician or group. Reply ↓

Patrick McDonald on November 25, 2012 at 5:51 pm said:
I have been researching, investigating, speaking & writing on the ugly reality of physician misbehavior for more than a decade. I've seen it from the inside and out.

What any cursory investigation reveals is truly jaw-dropping:

    NO other profession injures & kills more citizens unnecessarily;

    No segment of professionals escape more appropriate discipline upon being found guilty

    2,500+ doctors are found responsible of Felony-level crimes each year – another 5,500 convicted of "lesser" bad behavior.

    Health Care almost never reports its own miscreants to authorities, as they are mandated by law to do.

The Nat'l Practitioner Data Bank holds files on a whopping 1/4 million physicians – just since 1985. A shocking number of them fall into the categories of "Dangerous" or "Questionable."

And that 250,000 is considered an extremely low number, by those who understand the scope of the misbehavior.

As a society, we are getting exactly what we tolerate – which as of this writing, includes skyrocketing health care costs, and almost exactly 500 innocent deaths . . . per day.

We are being enormously group-stupid in not bringing the roof down on the bad boys of medicine.

Maggie Mahar on November 25, 2012 at 6:19 pm said:
Patrick–

Thanks for the comment–I am afraid you are entirely right.

Why don't doctors police themselves and blow the whistle on bad doctors?

I've read that the "hazing" experience of med school causes doctors to bond with
each other: "anyone who has gone through this deserves to be a doctor."
That hazing–which includes being humiliated by people who are supposed to be
training you– makes doctors extremely sensitive to criticism.

These things may be true of many–though not necessarily most doctors.

A more practical reason is that doctors are concerned about being sued if they try to
blow the whistle on other doctors. (We need better laws protecting whistle-blowers).

Finally–and I am afraid this is a major reason– a great many hospital CEO's protect their
"rainmakers" –and this includes doctors who bring in revenues by doing too many surgeries (even when
they are very tired), too many unnecessary and expensive tests, etc. Often, if they're moving too fast and
doing too much, they make mistakes. If a colleague tries to bring this to the attention of the administration,
he may find himself in trouble. The politics inside hospitals can be ugly.

I wonder if you might want to write a guest post about this?
Click on "Contact Maggie" on the blog's home page.

[Oct 09, 2016] To Stent Or Not To Stent, That Is In Question

Notable quotes:
"... An internal review by Tennessee-based Hospital Corporation of America found unnecessary heart procedures being performed at several facilities, according to The New York Times. ..."
"... A 2011 study in the Journal of the American Medical Association found that only half of 144,000 nonemergency heart catheterizations - typically the use of tiny balloons and stents to clear blocked arteries - were appropriate; 38 percent were "uncertain" and 12 percent were "inappropriate." ..."
"... "It's presented in the media as if it's an aberrancy, when actually it's the rule," said Dr. David Brown, an interventional cardiologist and professor of medicine at SUNY-Stony Brook School of Medicine of the unnecessary heart procedures. "The medical system is addicted to the revenues that it generates." ..."
"... Comparisons to common practice among doctors and hospitals may not be the best barometer of proper patient care. Studies show that doctors often do not adhere to best practices when they treat patients who have plaque buildup in their coronary arteries but whose condition is stable. ..."
"... About 600,000 procedures are performed every year to clear coronary artery blockages, according to the American Heart Association. The procedure involves snaking a catheter through the patient's arteries and clearing the blockage with a tiny balloon and a small wire cage - the stent - that holds the artery open. ..."
"... But studies show that medicine alone is as effective in patients with stable heart disease and that many procedures to clear blockages are unnecessary. Brown published a review of eight studies and found "there's absolutely no evidence" for substituting stents for medical therapy in patients with stable heart disease, he said. ..."
"... Editor's Note: ProPublica is working on a project to document cases of harm to patients. You can share your story by filling out our Patient Harm Questionnaire , or by joining our ProPublica Patient Harm Community on Facebook . ..."
Aug 08, 2012 | www.propublica.org
by Marshall Allen As Hospital Corporation of America comes under scrutiny, experts say unnecessary heart procedures are common, costing taxpayers, driving insurance premiums and putting patients at risk.

An internal review by Tennessee-based Hospital Corporation of America found unnecessary heart procedures being performed at several facilities, according to The New York Times.

New accusations that one of the nation's largest hospital chains performed more than a thousand unnecessary heart procedures grabbed headlines this week, but the practice is far from unique in U.S. health care.

A 2011 study in the Journal of the American Medical Association found that only half of 144,000 nonemergency heart catheterizations - typically the use of tiny balloons and stents to clear blocked arteries - were appropriate; 38 percent were "uncertain" and 12 percent were "inappropriate."

"It's presented in the media as if it's an aberrancy, when actually it's the rule," said Dr. David Brown, an interventional cardiologist and professor of medicine at SUNY-Stony Brook School of Medicine of the unnecessary heart procedures. "The medical system is addicted to the revenues that it generates."

In 2011, Medicare alone spent nearly $1 billion on the procedures. While they boost revenues for doctors and hospitals, unnecessary procedures consume taxpayer money, raise insurance premiums and put patients at risk. Studies show that about 3 percent of patients experience serious complications .

The New York Times reported this week that the U.S. attorney's office in Miami is investigating allegations that patients underwent unnecessary heart treatments at facilities owned by Tennessee-based Hospital Corporation of America, a 163-hospital chain.

According to the Times, an internal HCA review found unnecessary procedures being performed at several facilities, including more than 1,200 at Lawnwood Regional Medical Center & Heart Institute, in Fort Pierce, Fla.

HCA did not return a call for comment, but said in a statement posted on its website that there's wide disagreement among physicians about which procedures are medically necessary and its use of stents was within the range of those at other hospitals.

Comparisons to common practice among doctors and hospitals may not be the best barometer of proper patient care. Studies show that doctors often do not adhere to best practices when they treat patients who have plaque buildup in their coronary arteries but whose condition is stable.

About 600,000 procedures are performed every year to clear coronary artery blockages, according to the American Heart Association. The procedure involves snaking a catheter through the patient's arteries and clearing the blockage with a tiny balloon and a small wire cage - the stent - that holds the artery open.

But studies show that medicine alone is as effective in patients with stable heart disease and that many procedures to clear blockages are unnecessary. Brown published a review of eight studies and found "there's absolutely no evidence" for substituting stents for medical therapy in patients with stable heart disease, he said.

The American Heart Association recommends putting patients with stable heart disease on blood thinning medication before they try a stent, said the authors of a May 2011 study in the Journal of the American Medical Association. Yet it happens in fewer than half of the cases where doctors use stents, the study found .

There is some debate about the scope of the problem.

Dr. William Zoghbi, president of the American College of Cardiology, says there are "pockets" around the country where unnecessary procedures are more prevalent. The college offers seminars and guidelines on appropriate use for doctors, he said, and keeps a national registry so they can compare their practices to others. Zoghbi said the educational efforts are showing signs of success.

Unnecessary stenting persists in part because doctors are not explaining the medication-alone option to patients, said Dr. Michael Barry, president of the Informed Medical Decisions Foundation, which has created a guide of treatment choices for patients with stable heart disease .

Barry was part of a team of researchers that surveyed 472 Medicare patients with stable heart disease about their interactions with doctors who performed nonemergency stent procedures on them. A key finding : Only 6 percent of the patients said their doctor offered medication as an alternative to a stent.

Editor's Note: ProPublica is working on a project to document cases of harm to patients. You can share your story by filling out our Patient Harm Questionnaire , or by joining our ProPublica Patient Harm Community on Facebook .

Correction: This post originally said that the Archives of Internal Medicine found that only half of 144,000 nonemergency heart catheterizations were appropriate. It was actually the Journal of the American Medical Association.

Tom

Aug. 8, 2012, 2:16 p.m.

I'm in healthcare and can tell you that there's an enormous amount of unnecessary procedures performed for the $$$. Also a lot of billing for procedures never performed, and even in some cases for patients never even seen. Some of the worst fraud and abuse is in cardiology, and… gastroenterology. Ted

Aug. 8, 2012, 2:50 p.m.

With licenses to steal, only the scrupulous place the patient ahead of the $$$ Eric Manheimer MD

Aug. 8, 2012, 3:09 p.m.

Very fine article. It is not just about "stents". Virtually all aspects of medicine from colonoscopies to mammography, to PSA's to what we pay for medications is part of the huge issue of "more is better" practice of US Medicine Inc. Warren Liebman

Aug. 8, 2012, 8:42 p.m.

I see that your survey is about patients that suffered harm through the insertion is stents. I had day surgery for a procedure unrelated to my heart. I had heart failure in the recovery room and was sent by ambulance to the nearby heart center where I had three stents inserted the next day.

My cardiologist thought the stents were the best alternative. I deferred to his opinion as I was unqualified to make the decision.

I was on Plavix for three years and now just blood pressure and cholesterol drugs. I am very pleased with the outcome.

M Felix Freshwater MD

Aug. 8, 2012, 8:58 p.m.

Carefully read the HCA online document that alleges that the number of cardiac caths and stent procedures has decreased per year.
Missing from the document is the number of HCA cath labs and HCA cardiologists doing the procedures.
As we know, HCA downsized so if it has fewer hospitals and or fewer cardiologists then there may be an increase in the number of procedures done per remaining hospital or remaining cardiologist. Greg

Aug. 9, 2012, 9 a.m.

Sadly, in America, Power & Profit take Precedence over People. John

Aug. 9, 2012, 9:22 a.m.

Given the setup, this is the inevitable result. With insurance in the way, doctors jump through hoops to get paid and money is invisible to the patient. Put those together, and the doctor has strong incentive (even if we completely ignore pressure from the pharmaceutical and other supply companies) to give everybody the most expensive health care possible, whether or not it's the best.

As Warren points out, stents are wonderful tools. But sledgehammers are also wonderful tools, and I wouldn't want to use such a tool to clean a dirty window. When you have the right tool for the right job, there's not much better.

And since, in this country, we confuse "health care" with "health insurance"-two completely unrelated things except through their placement in the dictionary-we drive to make it worse, every time.

And note, the organization in the middle always benefits. And they sell the idea to doctors that the problem with health care is fraudulent malpractice claims (i.e., blame the patient), while selling the idea to patients that we need protection from the big, bad doctor bills.

It's one of the best scams running, really. You keep the parties blaming each other AND play on the fear and implied threat that "it'd be a shame if something…happened to your health," while raking in profits from a biased system.

Patrick Hughes, MD, FACC

Aug. 9, 2012, 9:59 a.m.

The placement of a stent in a coronary artery that has no blockage (as described in the NY Times) is fraud. It also exposes the person receiving the stent to life-threatening complications at the time of the procedure and for years afterward. This is a criminal act that should be prosecuted aggressively. Innocent people deserve protection. Salvador

Aug. 10, 2012, 8:25 a.m.

I myself have had 6 procedures done, and they have been done because of actual blockage. My cardiologist that I have now is a very good Doctor; who use other ways of preventive care for someone like me, before doing any kind of senseless procedure. He communicates with me in every aspect of the disease that I have. As far I am concerned here in Austin Tx. I have had 2 cardiologist and have been wonderful, and I see no fraud in any of the cases that I have been with. what ever goes on in those parts of the country its because they have Dr. who don't care about their patients; only about how to rip off the federal government. Jason Buc

Aug. 10, 2012, 9:29 p.m.

So what are the guidelines for who ought to be stented vs those that ought to be treated with pharmacology? Is there ever a proper non-emergent stent? I am familiar with guidelines for who gets cathed emergently vs those that ought to receive fibrinolytics in the presence of mi. Salvador

Aug. 10, 2012, 9:44 p.m.

I don't know any guidelines, I am merely stating incidents that has happened to me. Believe me when I say that at the time of my procedures I felt I was on my dying bed massive MI and it took a lot out of me. I am still struggling but not as bad as I was then, and I am also under a major meds regimen, including blood thinner Effient. I have tried many other thinners that have failed me and appears that this one is doing its job (Effient). Sharon

Aug. 10, 2012, 11:09 p.m.

This is just the beginning of this reporting I hope ProPublica because you are hitting on THE most important driver of the ever increasing costs of healthcare. There is very little health in healthcare but there are huge profits.

And who pays when things go wrong? It's not the manufacturers or the doctors because you know frivolous lawsuits. The patients' in this country, if they were informed consumers would want more legitimate lawsuits that would weed out faulty products and procedures. Instead what we get are lawsuits that vilify a doctor when he doesn't use an expensive scan or treat with an expensive drug. Those lawsuits are allowed to proceed, step right up we'll help you sue your doctor. But when a product like gadolinium based contrasting agents is maiming and killing millions and GE is the manufacturer with the least stable product, the injuries go uncompensated. In these situations we have to pick up these costs through higher premiums, our largest employers pay and so do health insurance companies and the government. No matter what you think about health insurance companies and how evil they are they still shouldn't have to pay for GE's faulty products or other faulty products. Those costs should be borne by the ones that caused them. Great work ProPublica. I'm be watching and waiting for more reporting.

Steven

Aug. 13, 2012, 8:46 p.m.

While many unnecessary procedures are performed, some are actually related to the fact that patients consider one approach as 'doing something', and the medical approach as being passive and less thorough. A physician who does not perform a procedure has nothing to lose by recommending it. Any complications are the result of the operator. But if a procedure is not recommended and an event occurs, such as a heart attack, a physician may be blamed by the patient for 'not doing enough'. The fact that medical therapies may indeed be better than procedures is not strongly embedded in the culture of patients. And there is an aura of higher technology to procedures compared with medications.

This is an attitude that needs to change, both on the part of physicians and patients.

Salvador

Aug. 14, 2012, 12:18 a.m.

Perhaps everything that is being discussed here may make sense to some but not all. I'm sure that people are not ignorant; when they are being treated by a good Dr. or a very bad Dr.: that is why its always best top go for first, second, and even third diagnoses. As the old cliche goes we are only human, and we all make mistakes, must not be taken as advise when it comes down anybodies health. I my self am against lawsuits of any kind, as this is very degrading on both parts. Plus it goes contrary to what I believe and what I have been taught through the word of God. One thing I will say in the six procedures that I have had; I would rather do it all over again instead of having open heart surgery. The basic fact is, that we all have the cure within ourselves if we know how to do what is right, admittance, acceptance, and avoidance.

[Oct 09, 2016] What is Insurance Fraud

Notable quotes:
"... Medical provider knowingly submits false medical bills by billing for services not rendered, billing for wrong procedure codes or billing for procedures of a medical necessity when procedures may have been elective or cosmetic in nature and not covered by health insurance. ..."
Oct 09, 2016 | insurance.ca.gov
Medical Medical

Inflated Billing - Inflated billing by any medical facility, doctor, chiropractor, laboratory, etc.

Healthcare

Billing Fraud - Medical provider knowingly submits false medical bills by billing for services not rendered, billing for wrong procedure codes or billing for procedures of a medical necessity when procedures may have been elective or cosmetic in nature and not covered by health insurance.

[Oct 09, 2016] Cardiac Stent Malpractice – Overuse of Stents Linked to Patient Deaths

Notable quotes:
"... Blood clots can occasionally form in an inserted stent, which can then lead to the artery narrowing once again. In some cases, the blood vessel can become completely blocked – a condition called in-stent thrombosis. ..."
"... Most patients that undergo stenting are prescribed blood thinners in the wake of the procedure to ensure such events don't occur. ..."
"... Cardiac stents are big business for hospitals and their staff, with the average private insurance reimbursement for a procedure totaling $25,000. By placing a stent inside an artery, surgeons can restore blood flow that has been compromised in heart attack patients, or give help to patients at risk for future heart attack. But when misused or overused in patients, cardiac stents can prove fatal, as they did for former postal service worker Bruce Peterson. ..."
"... Peterson developed several blood clots and blockages due to his weakened heart, which ultimately caused his untimely demise, argues his widow Shirlee Peterson. ..."
"... Nortin Hadler, a UNC Chapel Hill professor of medicine told Bloomberg News, "Stenting belongs to one of the bleakest chapters in the history of Western medicine. Cardiologists "are marching on" because "the interventional cardiology industry has a cash flow comparable to the GDP of many countries" and doesn't want to sacrifice the revenue, he said. ..."
Oct 09, 2016 | medstak.com
Ava Lawson

November 7, 2013

About a third of all cardiac stents implanted in patients are unnecessary, says cardiologist David Brown of Stony Brook University School of Medicine. That amounts to more than 200,000 stents a year, and controversy surrounding this practice has spurred nationwide litigation and a federal investigation into several cases involving illegal kickbacks and allegations of cardiac stent malpractice.

For the most part, stenting procedures are relatively low in risk and moderately safe. However, as with any surgical procedure – even a minimally invasive one – there is a risk of developing complications. Blood clots can occasionally form in an inserted stent, which can then lead to the artery narrowing once again. In some cases, the blood vessel can become completely blocked – a condition called in-stent thrombosis.

Most patients that undergo stenting are prescribed blood thinners in the wake of the procedure to ensure such events don't occur.

Additionally, manipulating arteries with a stent or any other sort of medical procedure can lead to the walls of the blood vessel becoming injured or damaged. The innermost layer of coronary arteries, known as the endothelium, is particularly susceptible to this sort of damage; the result can be the formation of scar tissue in the area of the stent, and this too can lead to the artery re-narrowing in a process known as restenosis. Treating Restenosis can involve an additional stenting procedure, though in severe cases where a stented artery recloses it may be necessary to have a patient undergo a coronary artery bypass to remedy the condition.

Overuse of cardiac stents leads to patient deaths

Cardiac stents are big business for hospitals and their staff, with the average private insurance reimbursement for a procedure totaling $25,000. By placing a stent inside an artery, surgeons can restore blood flow that has been compromised in heart attack patients, or give help to patients at risk for future heart attack. But when misused or overused in patients, cardiac stents can prove fatal, as they did for former postal service worker Bruce Peterson.

After suffering chest pain, Peterson paid a visit to cardiologist Dr. Samuel DeMaio, who inserted 21 stents in his patient's chest over a period of eight months, including five mesh tubes in a single artery. Peterson developed several blood clots and blockages due to his weakened heart, which ultimately caused his untimely demise, argues his widow Shirlee Peterson.

She later sued DeMaio for cardiac stent malpractice – an increasingly common charge in a Dr. Darshan P. Godkar, MD - Cedar Knolls, NJ - Cardiology & Interventional Cardiology & Internal Medicine Healthgrades.comqaDr. Darshan P. Godkar, MD - Cedar Knolls, NJ - Cardiology & Interventional Cardiology & Internal Medicine Healthgrades.com

Nortin Hadler, a UNC Chapel Hill professor of medicine told Bloomberg News, "Stenting belongs to one of the bleakest chapters in the history of Western medicine. Cardiologists "are marching on" because "the interventional cardiology industry has a cash flow comparable to the GDP of many countries" and doesn't want to sacrifice the revenue, he said.

Cardiac stent problems cost $2.4 billion a year

The U.S. health care system spends an estimated $2.4 billion a year caring for patients that received unnecessary cardiac stents, says Dr. Sanjay Kaul, of Cedars-Sinai Medical Center. Patients face a much greater risk for complications like coronary scar tissue, blood clots and uncontrolled bleeding from anticoagulant medications – all of which can be life-threatening. Jim Simecek told Bloomberg that he is on blood-thinning medicine for the rest of his life to prevent clots in the cardiac stents he received from a Cleveland doctor who is currently the subject of a federal probe.

Sixty-four year old Monica Crabtree's cardiac stent problems caused a torn artery, which resulted in an infection and her death, according to her husband. He also pursued legal action after it was determined by another cardiologist that Monica's stent was completely needless. The surviving spouse recovered $240,000 in a malpractice settlement brought against the surgeon.

FDA reports hundreds of deaths attributed to cardiac stents

Some 773 patient deaths linked with cardiac stents were logged with the FDA last year, according to Bloomberg. Though this figure has jumped more than 70 percent since 2008, with recent media coverage on cardiac stent overuse and ongoing federal investigations, cardiologists may be using fewer stents and only on suitable patients.

John Harold, president of the American College of Cardiology said the doctors who have been charged with cardiac stent malpractice or fraud are essentially "outliers" in their community, and that these surgeons fail to represent the "overwhelming majority."

[Oct 09, 2016] Deaths Linked to Cardiac Stents Rise as Overuse Seen

Notable quotes:
"... Jashu Patel, an interventionalist in Jackson, Michigan, billed $2.7 million for procedures in 2007, according to a U.S. Justice Department case against him settled in July. (He is no relation to Mehmood Patel). ..."
"... The suit alleged Patel implanted needless stents in at least two patients, including one that led to a blood clot that killed an unnamed woman who had reported no symptoms of reduced cardiac blood supply. A stress test showed normal blood flow, and notes in her file said she didn't want interventions, said Julie Kovach, a cardiologist who worked with Patel and brought the case to the government's attention. ..."
"... "It was appalling," Kovach said in an interview. "Patel coerced her into getting a stent she didn't need, which killed her." ..."
"... "He's their cash cow," said Kovach, now co-director of a clinic that treats congenital heart disease at the Detroit Medical Center. "They're not about to turn him in." ..."
"... Patel continues to practice at the hospital and must improve record-keeping to substantiate cardiology procedures, Allegiance said. In the settlement, Patel agreed to hire a consultant to oversee treatment of his patients and an auditing firm to monitor billings. He didn't return phone messages. ..."
"... "I do believe that Bruce was a guinea pig," she said. "That was the way it was done." ..."
Oct 09, 2016 | www.bloomberg.com

Bloomberg

When Bruce Peterson left the U.S. Postal Service after 24 years delivering mail, he started a travel agency. It was his dream career, his wife Shirlee said.

Then he went to see cardiologist Samuel DeMaio for chest pain. DeMaio put 21 coronary stents in Peterson's chest over eight months, and in one procedure tore a blood vessel and placed five of the metal-mesh tubes in a single artery, the Texas Medical Board staff said in a complaint. Unneeded stents weakened Peterson's heart and exposed him to complications including clots, blockages "and ultimately his death," the complaint said.

DeMaio paid $10,000 and agreed to two years' oversight to settle the complaint over Peterson and other patients in 2011. He said his treatment didn't contribute to Peterson's death.

"We've learned a lot since Bruce died," Shirlee Peterson said. "Too many stents can kill you."

Peterson's case is part of the expanding impact of U.S. medicine's binge on cardiac stents -- implants used to prop open the arteries of 7 million Americans in the last decade at a cost of more than $110 billion.

When stents are used to restore blood flow in heart attack patients, few dispute they are beneficial. These and other acute cases account for about half of the 700,000 stent procedures in the U.S. annually.

Among the other half -- elective-surgery patients in stable condition -- overuse, death, injury and fraud have accompanied the devices' use as a go-to treatment, according to thousands of pages of court documents and regulatory filings, interviews with 37 cardiologists and 33 heart patients or their survivors, and more than a dozen medical studies.

'Marching On'

These sources point to stent practices that underscore the waste and patient vulnerability in a U.S. health care system that rewards doctors based on volume of procedures rather than quality of care. Cardiologists get paid less than $250 to talk to patients about stents' risks and alternative measures, and an average of four times that fee for putting in a stent.

"Stenting belongs to one of the bleakest chapters in the history of Western medicine," said Nortin Hadler, a professor of medicine at the University of North Carolina at Chapel Hill. Cardiologists "are marching on" because "the interventional cardiology industry has a cash flow comparable to the GDP of many countries" and doesn't want to lose it, he said.

Stenting abuse is by no means the norm, but neither is it a rarity. Federal cases have extended from regional medical centers in Louisiana, Kentucky and Georgia to a top-ranked metropolitan hospital system in Ohio.

Asset Seizure

A doctor practicing at a hospital owned by the Cleveland Clinic, rated the premier heart center in the country by U.S. News and World Report, had his assets seized by federal agents in a stent investigation, according to federal court filings in April. The Clinic has not been accused of wrongdoing, and says it's cooperating with the investigation.

Two out of three elective stents, or more than 200,000 procedures a year, are unnecessary, according to David Brown, a cardiologist at Stony Brook University School of Medicine in New York. That works out to about a third of all stents.

Brown said his estimate is based on eight clinical trials of 7,000 patients in the last decade, which he analyzed in the Archives of Internal Medicine last year. Two cardiology researchers who have studied the use of stents say the number could be as low as about half Brown's estimate, and one said it is probably larger.

Costs, Risks

Even the low end of these estimates translates into more than a million Americans in the past decade with implants in their coronary arteries they didn't need, said William Boden, chief of medicine at a Veterans Administration hospital in Albany, New York. Boden was the principal investigator of a 2007 study known as Courage that found stents added no benefit over medicines, exercise and dietary changes in stable patients.

Unnecessary stents cost the U.S. health care system $2.4 billion a year, according to Sanjay Kaul, a cardiologist and researcher at Cedars-Sinai Medical Center in Los Angeles. Patients who received them are living with risks including blood clots, bleeding from anti-clotting medicine and blockages from coronary scar tissue, any of which can be fatal, Kaul said.

Monica Crabtree died at age 64 after one of her arteries was torn in a stent procedure that led to infection, according to her widower, Gary Crabtree. He received at least $240,000 from a 2011 settlement of his lawsuit against her doctor, after a second cardiologist reviewed the case and told him the stent wasn't needed. Crabtree choked up speaking about his late wife and showed pictures of their 47 years together.

Worried Shaving

"It wasn't just a simple mistake," said the retired auto worker in Largo, Florida. "If the stent was something she really needed, I could have handled it. But it was a total loss of life that didn't need to happen."

Jim Simecek, of Medina, Ohio, said he worries every morning that a nick from shaving could bleed out of control. Simecek, who works at a Ford dealership, said he has to take blood-thinning medicine for life to ward off clots in the six stents he received from a Cleveland-area cardiologist who's under federal investigation for his stent work.

"It's as if your heart was open and somebody was sticking a knife in," said Rhonda McClure, 54, referring to eight stents she received from a Kentucky cardiologist who agreed in June to plead guilty to a federal Medicaid-fraud charge for falsifying records used to justify a stent he placed.

Patient Letters

Cardiac stents were linked to at least 773 deaths in incident reports to the U.S. Food and Drug Administration last year, according to a review by Bloomberg News. That was 71 percent higher than the number found in the FDA's public files for 2008. The 4,135 non-fatal stent injuries reported to the FDA last year -- including perforated arteries, blood clots and other incidents -- were 33 percent higher than 2008 levels.

The FDA declined to comment on whether the reports were a cause for concern. It said adverse-event reports tied to medical devices have increased overall due to agency efforts. It also said the data can contain incomplete and unverified accounts from reporting parties.

More than 1,500 patients have gotten letters from hospitals since 2010 alerting them that their stents may have been unnecessary. In Philadelphia, the University of Pennsylvania Health System sent 700 such notices in April.

Stenting Decline

At least 11 hospitals have settled federal allegations of charging for needless stenting and other misdeeds in the catheterization labs where the procedures are performed. Federal probes of stenting practices continue in at least five states. In Louisiana and Maryland, cardiologists went to federal prison last year for implanting the devices and charging for them without medical justification. A third doctor has agreed to do time in a plea bargain.

"There is a huge financial incentive to increase the number of these procedures," said Jamie Bennett, a former assistant U.S. Attorney in Baltimore who handled stent investigations. "The cases we have seen to date are just the tip of the iceberg."

Since Boden's Courage study, stenting procedures have declined by about 20 percent. Still, this July, a panel of experts convened by the American Medical Association and the Joint Commission, a hospital accreditor, named elective stenting as one of five overused treatments that too often "provide zero or negligible benefit to patients, potentially exposing them to the risk of harm."

Better Choices

Doctors are using fewer stents and choosing more-appropriate patients than they were a few years ago, according to John Harold, president of the American College of Cardiology, the specialty's main professional group. Harold said that "real-world clinical practice" and research indicates Brown probably overestimated how many people with coronary artery disease could be handled initially only with drug-based treatment.

He said there are examples of inappropriate use and the ACC is taking steps to "address and correct the imbalance" with treatment guidelines and by urging more hospital oversight. Cardiologists who've been accused of fraud or are serving prison time are "outliers" who don't represent the "overwhelming majority."

Lawyers for John McLean, a Salisbury, Maryland, cardiologist convicted of billing for unwarranted stenting, argued in a federal appeal last year that inappropriate usage is widespread and their client was prosecuted for behavior that's the industry norm.

Lost Appeal

They cited a 2011 study in the Journal of the American Medical Association that found only half of elective stent procedures nationally were appropriate under usage guidelines written by societies of heart specialists. The study found 12 percent were inappropriate, and 38 percent fell into the uncertain category of the guidelines.

"The study demonstrated clearly that a large number of stable patients receive coronary artery stents that are later found to be inappropriate or questionable," the appeal argued. "The same was true of the patients in Dr. McLean's practice." McLean's appeal was denied in April. He is serving an eight-year sentence.

Elective-stent patients typically see rapid quality-of-life improvements, including in their ability to work and be active, according to Ted Bass, president of the Society for Cardiovascular Angiography and Interventions, whose members specialize in cardiac implants. The Courage trial found stents, compared to medication and lifestyle changes, were better at relieving chest pain for as long as two years after placement -- a benefit that ended by 36 months.

Profit Centers

First used in Europe in 1986, cardiac stents took off in the 2000s as cardiologists found them to be more effective in heart attacks than angioplasty. In that earlier technology, a small balloon is inflated to widen blood passages and then withdrawn. Stenting facilities, known as "cath labs," spread at hospitals and became profit centers.

Hospitals receive an average payment of about $25,000 per stent case from private insurers, according to Healthcare Blue Book, a website that tracks reimbursements. The federal Medicare program pays less. Doctors who implant stents earn a separate fee that averages about $1,000 and ranges from $500 to $2,850, according to Medicare and Blue Book data.

The procedure typically involves inserting the stent with a catheter through a small incision in the groin area or wrist and snaking it through to heart vessels. It usually takes less than 45 minutes.

Kickbacks Alleged

Stony Brook's Brown, and Boden, who led the Courage study, argue that many elective patients should be getting medical therapy before they risk stents. Only 44 percent try medication and lifestyle changes before stenting, a 2011 study in the Journal of the American Medical Association found.

At least five hospitals have reached settlements with the Justice Department over allegations that they paid illegal kickbacks to doctors for patient referrals to their cath labs. St. Joseph Medical Center in Towson, Maryland, paid the government $22 million without admitting liability.

Prosecutors alleged the hospital paid kickbacks to a practice co-founded by Baltimore cardiologist Mark Midei for stent referrals. His doctor's license was revoked in 2011 when the Maryland Board of Physicians found he falsified records to justify unwarranted stents.

St. Joseph told 585 of its patients they may have received unnecessary stents. In May, 252 patients reached a settlement with the hospital under confidential terms, according to Jay D. Miller, an attorney for the plaintiffs.

Plea Agreement

The hospital settled the government's case "to avoid the expense and uncertainty of litigation," it said in a statement. Spokeswoman Julia Sutherland said the hospital declined to comment on any patient lawsuits.

In an interview, Midei denied he stented without medical need. He took issue with experts who deemed many of his stents needless, and said disagreement among cardiologists on cases is common. Midei was not a party to the federal settlement. The government has said its investigation of the case continues.

In June, Sandesh Patil, a cardiologist practicing at another St. Joseph hospital -- this one in London, Kentucky -- agreed to plead guilty to charging Medicaid for a stent that wasn't medically warranted under the program's rules. (Although both hospitals were once owned by the same parent, the one in Maryland has been sold.)

Catheterization procedures multiplied at St. Joseph in London after Patil began practicing there in 2000, when the hospital had a different name. In that year, the type of procedure used for stents was done 210 times. They climbed to 929 by 2009, state data show.

Multiple Stents

Stenting income from Medicare alone was more than a sixth of the hospital's 2009 operating income, based on data from American Hospital Directory, a research firm. When Patil left London in 2010, catheterization procedures fell 34 percent from their 2009 high. Using the midpoint of the directory's price range for such procedures, the decline would have cost the hospital about $15 million. David McArthur, the hospital's spokesman, declined to comment on its revenues.

Rhonda McClure, one of Patil's patients, had her arteries catheterized 18 times by him and his partners over four years, according to her deposition and other filings in a lawsuit she and 361 other patients have brought against Patil, St. Joseph and other doctors who practiced there. She said she received eight cardiac stents. The defendants deny the negligence and fraud allegations against them.

McClure's deposition says a cardiologist who reviewed her case after the stents told her that scarring caused by "too many procedures" was her main problem.

Short Breath

McClure said she suffers from chest pain and shortness of breath, and has been told by her new doctor that she may need more stents and surgery to keep her coronary arteries from closing. She said she gets so tired she needs to sit and rest after walking down the stairs.

St. Joseph-London repaid Medicare $256,800 for unnecessary procedures and is cooperating with federal prosecutors, McArthur said. He said Patil was never employed by St. Joseph and lost his privileges to practice there in December 2010. Patil's attorney said his client had no comment.

Under his plea bargain, Patil agreed to serve 30 to 37 months in federal prison. He forfeited his Kentucky medical license for five years. In 2012, he told a family court judge his monthly income was $53,300.

"Thirty-seven months is nothing for all the injuries he done for money," McClure said.

Message Balancing

After the Courage trial shed doubt on stents' effectiveness for stable patients, stent-implanting cardiologists felt unfairly attacked and organized a campaign to "better balance the messaging," said Bonnie Weiner, who was president of the Society for Cardiovascular Angiography and Interventions at the time.

The society hired a public relations firm and paid it more than $300,000 a year to help publicize the benefits of stents, according to the group's filings with the Internal Revenue Service. The firm helped launch a consumer website for SCAI, SecondsCount.org, which has published several articles, including one under the headline, "For many patients, open arteries are better than closed arteries."

SCAI collected $2.7 million in donations for "public education" between 2008 and 2011 from stent makers Abbott Laboratories Inc., Boston Scientific Corp., Cordis Corp. and Medtronic Inc., its Web site says. Manufacturers' sales of cardiac stents were about $5.5 billion globally last year, down 5 percent from 2011, according to the Health Research International consulting firm.

High Median

Medtronic spokesman Joseph McGrath said grants to SCAI for patient education are "unrestricted," and SCAI is solely responsible for how the funds are used. Spokesmen for Abbott, Boston Scientific and Cordis declined to comment.

Interventional cardiologists, the specialty SCAI represents, earn a median income of $562,855 a year, as compared to $207,117 for family doctors, according to Medical Group Management Association, which surveys physician practices. The interventionalists ranked 13th among 118 specialties tracked by MGMA.

Michigan Death

Mehmood Patel, a Lafayette, Louisiana, cardiologist who went to prison last year on 51 counts of charging for needless stents, made over $16 million in one three-year span, evidence in the case showed. Prosecutors said he was driven by the desire to be the busiest cardiologist in town.

He unsuccessfully argued that he used his best medical judgment in every case and lost an appeal. Patel is serving a 10-year sentence in a federal penitentiary.

Jashu Patel, an interventionalist in Jackson, Michigan, billed $2.7 million for procedures in 2007, according to a U.S. Justice Department case against him settled in July. (He is no relation to Mehmood Patel).

The suit alleged Patel implanted needless stents in at least two patients, including one that led to a blood clot that killed an unnamed woman who had reported no symptoms of reduced cardiac blood supply. A stress test showed normal blood flow, and notes in her file said she didn't want interventions, said Julie Kovach, a cardiologist who worked with Patel and brought the case to the government's attention.

"It was appalling," Kovach said in an interview. "Patel coerced her into getting a stent she didn't need, which killed her."

False Claims

Kovach said that when she told the chief operating officer of the hospital where Patel worked about the death, the executive, Karen Chaprnka, diverted the conversation. Reached recently by e-mail through a hospital spokesman, Chaprnka said she "disagreed with the allegations made by Dr. Kovach."

"He's their cash cow," said Kovach, now co-director of a clinic that treats congenital heart disease at the Detroit Medical Center. "They're not about to turn him in."

Patel and the hospital, Allegiance Health, agreed to pay the U.S. a total of $4 million to settle the federal charges. Kovach was awarded $760,000 as a whistle-blower under the U.S. False Claims Act. Allegiance disagreed with the allegations and settled the claims to avoid "lengthy litigation," it said in a statement.

Patel continues to practice at the hospital and must improve record-keeping to substantiate cardiology procedures, Allegiance said. In the settlement, Patel agreed to hire a consultant to oversee treatment of his patients and an auditing firm to monitor billings. He didn't return phone messages.

Cleveland Raid

In Ohio, Simecek, the worker at the Ford dealership, grew suspicious after his sixth stent from cardiologist Harry Persaud at the Cleveland Clinic's Fairview Hospital in 2011. Simecek said he went for a second opinion and was told he didn't need any of the stents. Now he said he has to take blood thinners the rest of his life.

"With the littlest cut, the blood starts running," said Simecek. "What if I am in an auto accident?"

Persaud is under criminal investigation for health care fraud, mail fraud and money laundering, according to federal court filings. Last October, Federal Bureau of Investigation agents raided his office and removed financial records and patient files for procedures at three Cleveland-area hospitals. The government has seized $343,634 from his and his wife's bank accounts, alleging the funds represent the proceeds of fraud related to a "significant number" of unnecessary stent procedures.

Multiple, Elongated

The Cleveland Clinic found "problems related to the use of stents in some patients" at Fairview and reported them to the government, according to spokeswoman Eileen Sheil. She would not say how many patients were affected. Persaud resigned from the hospital staff last year.

At least 64 of Persaud's patients at St. John Medical Center in suburban Westlake received letters from the hospital saying they may have received an unnecessary stent between 2010 and 2012, according to spokesman Patrick Garmone, who said Persaud no longer practices there.

Persaud denied wrongdoing in court filings and said his stent procedures were proper. Neil Freund, his attorney in lawsuits filed by patients alleging unwarranted stents, said "it is our intent to defend these cases." He had no comment on the federal investigation.

Final Order

In Texas, the state medical board's final order in DeMaio's case found that the cardiologist placed "multiple, elongated, overlapping" stents in patients in areas of "insignificant or only moderate disease." Peterson, the retired mailman, was identified only as Patient C in the staff complaint. No patient was mentioned in the final order.

Peterson was thriving in his new career in the travel business, his wife Shirlee said. He had a heart attack in 1997, which didn't crimp his love of travel and dance, she said. "He was an awesome man who never met a stranger," she said.

After his death, Shirlee Peterson said a friend told her she had a cardiologist who refused to do multiple stents.

"I do believe that Bruce was a guinea pig," she said. "That was the way it was done."

DeMaio said Peterson was extremely sick when he came to him. He said it was significant that the board's final order didn't use the word "excessive" in describing his stent work. That included 31 stents stretching for 14 inches inside the arteries of Patient B in the staff complaint.

"Any patient of mine who received a full metal jacket" -- interventional cardiology's term for such extensive work -- "would have been turned down by at least one, if not multiple surgeons," DeMaio said. He said he doesn't use stents as much these days because standards have changed and he doesn't see as many seriously ill patients.


[Oct 09, 2016] Heart Stent Problems - Drug Eluting Stent Lawsuits

Oct 09, 2016 | www.youhavealawyer.com

Heart stents are small wire-mesh tubes which are used to keep previously clogged arteries open. Following heart bypass surgery and angioplasty, the stents are left in the artery to prevent it from re-closing. Stents gained widespread use in the medical community during the 1990s. Original designs were bare metal devices inserted into the arteries.

Since 2003, newer types of heart stents containing a medication coating have dominated the stent market. The Johnson and Johnson Cypher heart stent was introduced in 2003 and the Boston Scientific Taxus heart stent was introduced in 2004. These medicated stents have been linked to an increased risk of serious blood clots which could occur years after the stent is implanted.

Medicated stent lawsuits are being reviewed by the lawyers at Saiontz & Kirk, P.A. for individuals who have suffered:

To find out if you, a friend or family member may be entitled to compensation, request a free consultation and claim evaluation .

Heart Stent Lawyers

The lawyers at Saiontz & Kirk are investigating potential heart stent lawsuits for individuals throughout the United States who have experienced problems.

REVIEW A CASE

Drug eluting stents were designed to prevent the formation of scar tissue inside of the cardiac arteries which could be caused by bare-metal stents. The drug-coating is intended to reduce inflammation at the site of the stent which could lead to tissue growth. The intended benefit of the drug coating is that it reduces the risk of new blockages forming by this scar tissue. However, recent studies have shown the drug coating could actually increase the risk of more serious and deadly blood clots.

The drug coating prevents heart cells from creating a biological lining around the metal of the stent. This leaves the metal exposed, which acts as a clot magnet for months and even years after the stent is implanted. When these blood clots form, it leads to a major heart attack or death approximately 70% of the time.

>>INFORMATION: Medicated Heart Stent Problems

As a result of the increased risk of heart stent blood clots, experts have recommended that patients take a blood thinning medication for significantly longer than what the manufacturers have been recommending. Currently the warning label for the Cypher heart stent recommends only three months of blood thinner and the Taxus heart stent recommends only six months. The increased risk of late stent thrombosis may require individuals to take a blood thinner for years, or even the rest of their lives. However, the necessity for continued use of anti-clotting drugs could carry additional risks. For example, Plavix side effects could include severe gastrointestinal bleeding, ulcers, heart attacks and strokes.

Since the heart stent problems have become more widely known, there has been a change in philosophy regarding the use of stents in heart patients. Many experts are indicating that drug coated stents have been used in many situations where bare-metal stents or long-term drug therapy would be a safer alternative. Only 20% of the drug eluting stents implanted each year are for patients meeting the profile for which they were approved by the FDA.

MEDICATED STENT LAWSUITS

It has been estimated that over 2,000 deaths each year could have been caused by drug coated heart stent problems. Although cardiologists previously expressed concerns about the safety of drug coated stents, the manufacturers have attempted to minimize the risks. They have previously taken the position that there is no difference in the risk of clotting between medicated stents and older bare metal. However, recent studies have established that this information is incorrect.

The medicated heart stent lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for individuals who have received a drug coated stent.. If you, a friend or family member have received a cardiac stent and suffered blood clots, heart attack or death, you may be entitled to compensation. There are no fees or expenses unless a recovery is obtained.

[Oct 09, 2016] Angioplasty overkill? Financial incentives may be driving surgeons to massively over-treat heart patients

Notable quotes:
"... Though the Elyria doctors say they are doing a good job and caring well for their patients, some experts say doctors with financial incentives to prescribe costly treatments cannot be completely unbiased when assessing how to treat a patient. "It's sort of like, you go to a barber and ask if you need a haircut," says Dr. David D. Waters, chief of cardiology at San Francisco General Hospital. "He's likely to say you do." ..."
Aug 21, 2006 | NewsTarget
(NewsTarget) Recent statistics show that a medical clinic in Elyria, Ohio prescribes profitable angioplasties for heart patients nearly four times as often as the rest of the country, which has raised questions among experts as to why the Elyria cardiologists recommend the procedure so often.

Almost all of the angioplasties at the Elyria hospital are performed by a group of cardiologists at the North Ohio Heart Center. The group's leader, Dr. John W. Schaeffer, says his group treats cardiac patients "very aggressively," and says his doctors simply detect disease more often than doctors in the rest of the country and are quicker to intervene.

However, outside experts say they are concerned that the Elyria doctors represent a larger trend in U.S. medicine, in which doctors make medical decisions based more on financial incentives than what is best and safest for the patient.

For example, Medicare pays the Elyria hospital $11,000 per angioplasty that uses a drug-coated stent, which earns the cardiologist roughly an extra $800. The Elyria doctors performed 3,400 angioplasties in 2004, which is three times the rate of the procedure in Cleveland, just 30 miles away. Dr. Eric Topol, a nationally recognized cardiologist at the Cleveland Clinic, says the Elyria hospital's high rate of angioplasties lacks "a good explanation," and says Elyria does not seem to have different risk factors than the rest of Ohio, which has much lower angioplasty rates.

"It's clear that when doctors and surgeons are financially rewarded for treating patients with certain profitable procedures, many will find a myriad of ways, either consciously or unconsciously, to come up with a diagnosis that benefits their personal bank accounts," said Mike Adams, a consumer health advocate and critic of unnecessary surgical procedures.

"This particular practice in Ohio seems to be an angioplasty factory rather than anything resembling genuine health care."

Other healthcare systems have adopted a way of paying doctors that effectively removes financial incentives for prescribing profitable treatments.

Kaiser Permanente says its Ohio patients are less likely to undergo the kinds of cardiac procedures performed at the Elyria hospital because its cardiologists work on a salary basis rather than being paid by the procedure.

Though the Elyria doctors say they are doing a good job and caring well for their patients, some experts say doctors with financial incentives to prescribe costly treatments cannot be completely unbiased when assessing how to treat a patient. "It's sort of like, you go to a barber and ask if you need a haircut," says Dr. David D. Waters, chief of cardiology at San Francisco General Hospital. "He's likely to say you do."

[Oct 08, 2016] Doctors should typically place stents only in patients who are having heart attacks or significant symptoms, such as chest pain

Notable quotes:
"... But stents haven't been shown to reduce the risk of heart attacks in patients without symptoms, says James Beckerman, a cardiologist at the Providence Heart and Vascular Institute in Portland, Ore. Stents also don't help these patients live longer. And Nissen notes that stents themselves can become clogged up, causing greater problems. ..."
"... Bush spokesman Ford said Tuesday that, while Bush didn't experience those symptoms, "the stent was necessary. His annual physical includes a stress test. EKG changes during the stress test yesterday prompted a CT angiogram, which confirmed a blockage that required opening." ..."
"... Nissen said he's concerned about "overtesting" and overtreating people like Bush when they have no symptoms. ..."
"... "He did a 100-kilometer bike ride," says Nissen, a feat that would be impossible for someone on the verge of a heart attack. "How can a stent make him better?" ..."
"... People without symptoms also don't need annual stress tests, in which patients walk on a treadmill while doctors perform a test called an EKG, or electrocardiogram, Nissen says. ..."
Oct 08, 2016 | www.usatoday.com

Patients typically will take blood thinners, such as aspirin and clopidogrel, which help prevent further clots, McPherson says. Doctors will also test Bush's cholesterol to see if he needs to take statins, which help reduce cholesterol and which, like clopidogrel and low-dose aspirin, would be taken for the rest of his life.

At 67, Bush is at an age that puts him at higher risk of a heart attack, McPherson says.

Yet Bush, an avid jogger and bicyclist, is exceptionally fit for a man of any age. Since leaving office, Bush has hosted 100-kilometer bicycle rides for wounded troops, the most recent in May near Waco.

But even a healthy lifestyle won't prevent all heart disease, McPherson says. And while the stent indicates that Bush has an increased risk of heart attack, managing his risk factors, such as his cholesterol and blood pressure, will help keep him healthy.

The Cleveland Clinic's Steven Nissen questions whether Bush will really benefit from a stent. Doctors typically place stents only in patients who are having heart attacks or significant symptoms, such as chest pain, says Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. Stents can help keep blood flowing and reduce the risk of a heart attack in these patients.

But stents haven't been shown to reduce the risk of heart attacks in patients without symptoms, says James Beckerman, a cardiologist at the Providence Heart and Vascular Institute in Portland, Ore. Stents also don't help these patients live longer. And Nissen notes that stents themselves can become clogged up, causing greater problems.

Bush spokesman Ford said Tuesday that, while Bush didn't experience those symptoms, "the stent was necessary. His annual physical includes a stress test. EKG changes during the stress test yesterday prompted a CT angiogram, which confirmed a blockage that required opening."

A significant number of patients end up with stents after a routine physical, McPherson says. That's because some patients who experience occasional chest pain or shortness of breath may not tell anyone about their symptoms until a doctor asks.

Nissen said he's concerned about "overtesting" and overtreating people like Bush when they have no symptoms.

"He did a 100-kilometer bike ride," says Nissen, a feat that would be impossible for someone on the verge of a heart attack. "How can a stent make him better?"

People without symptoms also don't need annual stress tests, in which patients walk on a treadmill while doctors perform a test called an EKG, or electrocardiogram, Nissen says.

Bush likely "got the classical thing that happens to VIP patients, when they get so-called executive physicals and they get a lot of tests that aren't indicated. This is American medicine at its worst."

While it's possible to have a major artery blockage without symptoms, Nissen says that screening everyone with stress tests would end up doing more harm than good. That's because these screenings can lead to risky medical procedures that don't offer any proven benefit.

Still, McPherson notes that experts agree it makes sense to test certain professionals, such as school bus drivers and airline pilots, because a sudden heart attack on the job could cost many lives.

[Oct 08, 2016] Indications for stents

One motivation for insurance fraud is a desire for financial gain. Public healthcare programs such as Medicare and Medicaid are especially conducive to fraudulent activities, as they are often run on a fee-for-service structure.[20]
Notable quotes:
"... Recent studies show that medicine and angioplasty with stenting have equal benefits. Angioplasty with stenting does not help you live longer, but it can reduce angina or other symptoms of coronary artery disease. ..."
"... Angioplasty with stenting, however, can be a life-saving procedure if you are having a heart attack ..."
Yahoo Answers

A few days ago I answered the same question about Coronary Artery Bypass Graft (CABG) surgery. The indications are essentially the same.

Stents are used to open blockages in a tubule structure. They are most commonly known for their use in the coronary arteries but may be used in other areas as well. In the arteries they are used to spread the artery open where a blockage or narrowing has occurred. Some patients are served well by stents but others require CABG. The decision is normally made by the cardiologist. Stenting or CABG is determined by the number of blockages, the severity and their location(s). Normally, you go in for a catheterization.

If blockages are found and stents are needed, it will normally be done at that time. If CABG is required, they will complete the catheterization then arrangements will be made to perform the CABG.

To see the question on CABG and my and others answers click this link:

http://answers.yahoo.com/question/index;...

For information on stents click this link:

http://www.nhlbi.nih.gov/health/dci/Dise...

For information on CABG click this link:

http://www.nhlbi.nih.gov/health/dci/Dise...

There are a ton of other information sources. If you would like more just contact me by going to my profile. There you can click on "Email Terry S" or click the link below.

http://answers.yahoo.com/my/message_do?kid=AA10902014

Terry


gangadharan nair


The main purpose of a stent is to counteract significant decreases in vessel or duct diameter by acutely propping open the conduit by a mechanical scaffold or stent. Stents are often used to alleviate diminished blood flow to organs and extremities beyond an obstruction in order to maintain an adequate delivery of oxygenated blood. Although the most common use of stents is in coronary arteries, they are widely used in other natural body conduits, such as central and peripheral arteries and veins, bile ducts, esophagus, colon, trachea or large bronchi, ureters, and urethra.(Wikipedia)

Most of the time, stents are used to treat conditions that result when arteries become narrow or blocked. The devices are also used to unblock and keep open other tube-shaped structures in the body, including the ureters (the tubes that drain urine from the kidneys to the bladder) and bronchi (the small windpipes in the lungs).

Stents are commonly used to treat coronary heart disease (CHD). If you have coronary artery disease that does not cause symptoms, you can be treated with either medicine or angioplasty with stenting.

Recent studies show that medicine and angioplasty with stenting have equal benefits. Angioplasty with stenting does not help you live longer, but it can reduce angina or other symptoms of coronary artery disease.

Angioplasty with stenting, however, can be a life-saving procedure if you are having a heart attack

Other reasons to use stents include:

* Keeping open a blocked or damage ureter
* Treatment of aneurysms, including thoracic aortic aneurysms
* Unblocking a large artery, such as the carotid artery (carotid endarterectomy)
* To keep bile flowing in blocked bile ducts (biliary stricture)
* Helping you breathe if you have a blockage in the airways

Dr Frank

Stents are inserted routinely now at angioplasty to improve the chances of keeping the vessel open. They would be used for any lesion where the vessel is wide enough to take them. Since the routine use of better anti platelet drugs, clopidogrel, the risk that the stent itself will clot has been reduced dramatically.

Source(s):
GP for more years than I care to remember
Dr Frank · 9 years ago

[Oct 08, 2016] State of New Jersey office of the insurance fraud prosecutor

Notable quotes:
"... Toll Free 1-877-55-FRAUD (1-877-553-7283) ..."
"... Report Fraud Here! ..."
"... Reward Program ..."
www.nj.gov
Report Fraud...
Toll Free
1-877-55-FRAUD
(1-877-553-7283)
Report Fraud Here!
Reward Program

[Oct 08, 2016] Heart doctor in Ohio overbilled $7M for unnecessary procedures

Notable quotes:
"... A Westlake cardiologist was convicted of performing unnecessary catheterizations, tests, stent insertions and causing unnecessary coronary artery bypass surgeries as part of a scheme to overbill Medicare and other insurers by $7.2 million, law enforcement officials said. ..."
Sep 25, 2015 | Insurance Fraud News Service

A Westlake cardiologist was convicted of performing unnecessary catheterizations, tests, stent insertions and causing unnecessary coronary artery bypass surgeries as part of a scheme to overbill Medicare and other insurers by $7.2 million, law enforcement officials said.

Dr. Harold Persaud, 56, was convicted of one count of health care fraud, 13 counts of making false statements and one count of engaging in monetary transactions in property derived from criminal activity. He was acquitted on one count of making a false statement.

"The evidence presented at this trial was troubling," said U.S. Attorney Steven M. Dettelbach. "Inflating Medicare billings alone would be bad enough. Falsifying cardiac care records, making an unnecessary referral for open heart surgery and performing needless and sometimes invasive heart tests and procedures is inconsistent with not only federal law but a doctor's basic duty to his patients."

"This doctor violated the sacred trust between doctor and patient by ordering unnecessary tests, procedures and surgeries to line his pockets," said Stephen D. Anthony, Special Agent in Charge of the FBI's Cleveland Office. "He ripped off taxpayers and put patients' lives at risk."

"Medical providers have a duty and obligation to provide only those services that are medically necessary and are in the best interests of the patients under their care," said Lamont Pugh III, Special Agent in Charge, U.S. Department of Health & Human Services, Office of Inspector General – Chicago Region. "This conduct shows a disregard for patient needs in exchange for financial gain at taxpayer expense. The OIG will continue to work with our law enforcement and prosecutorial partners to identify fraudulent health care schemes and hold individuals accountable for their actions."

Persaud had a private medical practice at 29099 Health Campus Drive in Westlake and had hospital privileges at Fairview Hospital, St. John's Medical Center and Southwest General Hospital, according to court documents and trial testimony.

Persaud devised a scheme to defraud and obtain money from Medicare and other insurers. The scheme took place between Feb. 16, 2006, through June 28, 2012. According to according to court documents and trial testimony, his activities in furtherance of the scheme included:

Persaud selected the billing code for each customer submitted to Medicare and private insurers, and used codes that reflected a service that was more costly than that which was actually performed;

Persaud performed nuclear stress tests on patients that were not medically necessary;

He knowingly recorded false results of patients' nuclear stress tests to justify cardiac catheterization procedures that were not medically necessary;

Persaud performed cardiac catheterizations on patients at the hospitals and falsely recorded the existence and extent of lesions (blockage) observed during the procedures;

He recorded false symptoms in patient records to justify testing and procedures on patients;

Persaud inserted cardiac stents in patients who did not have 70 percent or more blockage in the vessel that he stented and who did not have symptoms of blockage;

He placed a stent in a stenosed artery that already had a functioning bypass, thus providing no medical benefit and increasing the risk of harm to the patient;

He improperly referred patients for coronary artery bypass surgery when there was no medical necessity for such surgery, which benefitted Persaud by increasing the amount of follow-up testing he could perform and bill to Medicare and private insurers;

Persaud performed medically unnecessary stent procedures, aortograms, renal angiograms and other procedures and tests.

As a result of this scheme, Persaud overbilled and caused the overbilling of Medicare and private insurers in the amount of approximately $7.2 million, of which Medicare and the private insurers paid approximately $1.5 million, according to the indictment.

This case is being prosecuted by Assistant U.S. Attorneys Michael L. Collyer and Chelsea Rice following an investigation by the Federal Bureau of Investigation and the U.S. Department of Health and Human Services – Office of Inspector General

[Oct 08, 2016] Heart Stent Problems - Drug Eluting Stent Lawsuits

Oct 08, 2016 | www.youhavealawyer.com

Heart stents are small wire-mesh tubes which are used to keep previously clogged arteries open. Following heart bypass surgery and angioplasty, the stents are left in the artery to prevent it from re-closing. Stents gained widespread use in the medical community during the 1990s. Original designs were bare metal devices inserted into the arteries.

Since 2003, newer types of heart stents containing a medication coating have dominated the stent market. The Johnson and Johnson Cypher heart stent was introduced in 2003 and the Boston Scientific Taxus heart stent was introduced in 2004. These medicated stents have been linked to an increased risk of serious blood clots which could occur years after the stent is implanted.

Medicated stent lawsuits are being reviewed by the lawyers at Saiontz & Kirk, P.A. for individuals who have suffered:

To find out if you, a friend or family member may be entitled to compensation, request a free consultation and claim evaluation .

DRUG ELUTING HEART STENT PROBLEMS

Injury Lawyers

Heart Stent Lawyers

The lawyers at Saiontz & Kirk are investigating potential heart stent lawsuits for individuals throughout the United States who have experienced problems.

REVIEW A CASE

Drug eluting stents were designed to prevent the formation of scar tissue inside of the cardiac arteries which could be caused by bare-metal stents. The drug-coating is intended to reduce inflammation at the site of the stent which could lead to tissue growth. The intended benefit of the drug coating is that it reduces the risk of new blockages forming by this scar tissue. However, recent studies have shown the drug coating could actually increase the risk of more serious and deadly blood clots.

The drug coating prevents heart cells from creating a biological lining around the metal of the stent. This leaves the metal exposed, which acts as a clot magnet for months and even years after the stent is implanted. When these blood clots form, it leads to a major heart attack or death approximately 70% of the time.

>>INFORMATION: Medicated Heart Stent Problems

As a result of the increased risk of heart stent blood clots, experts have recommended that patients take a blood thinning medication for significantly longer than what the manufacturers have been recommending. Currently the warning label for the Cypher heart stent recommends only three months of blood thinner and the Taxus heart stent recommends only six months. The increased risk of late stent thrombosis may require individuals to take a blood thinner for years, or even the rest of their lives. However, the necessity for continued use of anti-clotting drugs could carry additional risks. For example, Plavix side effects could include severe gastrointestinal bleeding, ulcers, heart attacks and strokes.

Since the heart stent problems have become more widely known, there has been a change in philosophy regarding the use of stents in heart patients. Many experts are indicating that drug coated stents have been used in many situations where bare-metal stents or long-term drug therapy would be a safer alternative. Only 20% of the drug eluting stents implanted each year are for patients meeting the profile for which they were approved by the FDA.

MEDICATED STENT LAWSUITS

It has been estimated that over 2,000 deaths each year could have been caused by drug coated heart stent problems. Although cardiologists previously expressed concerns about the safety of drug coated stents, the manufacturers have attempted to minimize the risks. They have previously taken the position that there is no difference in the risk of clotting between medicated stents and older bare metal. However, recent studies have established that this information is incorrect.

The medicated heart stent lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for individuals who have received a drug coated stent.. If you, a friend or family member have received a cardiac stent and suffered blood clots, heart attack or death, you may be entitled to compensation. There are no fees or expenses unless a recovery is obtained.

[Oct 08, 2016] Are Doctors Exposing Heart Patients to Unnecessary Cardiac Procedures

Notable quotes:
"... Angioplasty is performed in more than 600,000 patients a year – roughly half of them Medicare patients – often as an alternative to bypass surgery. ..."
"... A study published in the Journal of the American Medical Association in 2011 pegged the cost to the health care system at an estimated $12 billion a year. ..."
"... The procedure also has risks. About 5 percent of people suffer complications including bleeding, blood clots, infection, heart rhythm disturbances and even death from heart attack. ..."
"... When doctors install drug-coated stents, as most now do, patients must take aspirin and certain anti-clotting medications for a year to guard against life-threatening clots. ..."
"... But the need to rein in unnecessary procedures is still considered so pressing that the American College of Cardiology in 2012 published "appropriateness" criteria to guide physicians' judgment. ..."
"... Monroe ranks near the top of hospital referral regions with the highest level of "potentially avoidable hospital costs," according to the Commonwealth Fund Scorecard on Local Health System Performance. ..."
"... The question is: Are they doing things that need to be done? Or are they widget makers, putting in widgets because that's what the system incents them to do?" ..."
"... In 2012 alone, Paulus received $305,967 from Medicare for 923 catheterizations and angioplasties. His work accounted for more than 15 percent of all of the procedures performed in the region and made him the sixth-busiest cardiac catheterization specialist in the nation. Federal investigators were so struck by the hospital's high catheterization rates that they launched a probe of its catheterization laboratory. ..."
"... Last spring, the hospital agreed to pay the government $41 million to settle allegations that, between 2006 and 2011, the hospital submitted millions of dollars' worth of "false claims" to Medicare and Medicaid for performing angioplasties and implanting stents in "numerous" patients who did not need them, according to an FBI press release. ..."
"... "The decision to do the procedure is made by the person who would benefit from the procedure," says Dr. David O. Williams, a cardiologist at Brigham and Women's Hospital in Boston. ..."
Oct 08, 2016 | www.usnews.com

Feb. 11, 2015 | US News

Dr. Gregory Sampognaro is one of the busiest interventional cardiologists in the United States, clearing out clogged coronary arteries in hundreds of patients every year. Sampognaro ranked 17th in the U.S. in 2012 in the number of these procedures, according to a U.S. News & World Report analysis of Medicare data. What makes these numbers noteworthy is that Sampognaro works not in a medical mecca like New York or Chicago but in Monroe, Louisiana, a fading Mississippi-delta agricultural community of 54,000 in one of the poorest congressional districts in the U.S. Sampognaro is one of dozens of cardiologists in communities outside major metro areas who are performing catheterization procedures – such as diagnostic angiograms and artery-clearing angioplasties – at higher rates than doctors working at big city hospitals that serve as major cardiac referral centers, the U.S. News analysis found. While no one has accused Sampognaro of doing anything wrong, experts who have reviewed the U.S. News data say it raises a critical question, not just for patients seeking coronary care in Monroe but for those in other parts of the country: How many of these catheterization procedures are medically advisable and how many put patients at unnecessary risk and add billions of dollars to the nation's medical bill?

"You have to wonder what's going on," says Harvard physician and historian Dr. David Jones, author of "Broken Hearts: The Tangled History of Cardiac Care." "Are these doctors going to get bigger paychecks at the end of the month for doing more of these procedures? That may be an uncomfortable question to ask, but it's something patients should wonder about." By his own account, Sampognaro does most of the procedures in Monroe. "I already know that I'm one of the busiest cardiologists in the country," he says. "The reason is geography. I practice in an extremely underserved area. There are only four interventional cardiologists in northeast Louisiana. I'm one of four. In Shreveport, there's probably 30. Want to know why? No one wants to live in Monroe, except people who are from here. Now, if I was in some big city I wouldn't have those numbers because there are interventional cardiologists on every corner." Dwight Vines, Monroe's economic development officer, says it's "generally known" in Monroe that if you go see Sampognaro, he's likely to send you to the hospital for a procedure. "He sent me over." Vines says. "He does a lot of this." Until recently, U.S. doctors and their practice patterns were protected from scrutiny by a legal ruling that shielded Medicare data from public release. A U.S. District Judge lifted the ruling in 2014, making it possible for U.S. News and other organizations to examine Medicare data that reveal how doctors practice medicine, how much money they make and how they compare to their peers.

Angioplasties and related procedures are some of the most common and controversial in medicine.

Angioplasty is performed in more than 600,000 patients a year – roughly half of them Medicare patients – often as an alternative to bypass surgery.

A study published in the Journal of the American Medical Association in 2011 pegged the cost to the health care system at an estimated $12 billion a year.

Interventional cardiologists like Sampognaro insert a small tube called a catheter into a blood vessel in the patient's groin or wrist, and guide it to the coronary arteries. There they obtain diagnostic images and remove blockages. Expandable devices called stents are then inserted to prop open the blocked artery. Angioplasty's benefits are unquestioned for patients in the grip of a heart attack. Clearing a clogged artery and restoring the heart's blood supply can save a patient's life. In the two-thirds of patients who are not having heart attacks, however, angioplasty's benefits are far less clear. Angioplasty can relieve chest pain from chronic angina, but it cannot prevent heart attacks or prolong survival. Patients with unstable angina reap more symptom relief from angioplasty than from drug treatment. In chronic, stable heart-disease patients, studies show, drug treatment may work just as well angioplasty .

The procedure also has risks. About 5 percent of people suffer complications including bleeding, blood clots, infection, heart rhythm disturbances and even death from heart attack.

When doctors install drug-coated stents, as most now do, patients must take aspirin and certain anti-clotting medications for a year to guard against life-threatening clots.

"This is a very controversial arena. Any number of people don't want this exposed. Nobody wants to kill the goose that lays the golden egg," says William Boden, chief of medicine at the Albany Stratton VA Medical Center in Albany, New York. Boden was lead author of a study, published in 2007 in the New England Journal of Medicine, showing for the first time that optimal drug treatment worked as effectively as angioplasty and stenting in stable heart - disease patients.

A flurry of subsequent studies have since confirmed the finding and underpin the push to eliminate unnecessary procedures.

Experts have zeroed in on reducing the number of catheterizations as a way to slow rising health care costs. The total has declined dramatically since Boden's study, called Courage, appeared.

But the need to rein in unnecessary procedures is still considered so pressing that the American College of Cardiology in 2012 published "appropriateness" criteria to guide physicians' judgment.

Applying these standards nationwide could cut the number of catheterization procedures significantly, research shows. One study of more than 140,000 procedures, for instance, found that nearly 12 percent were unnecessary and 38 percent were questionable. The trouble is that it is difficult for anyone other than the cardiologist-or someone else with access to the patient's confidential medical record-to determine whether an interventional procedure is appropriate or not. The Medicare claims data used in the U.S. News analysis lack the critical information needed to make that determination.

But claims data can "flag hospitals that would potentially have a lot of cases that would then need to be investigated in more detail," says Edward Hannan, a professor of epidemiology at the State University of New York at Albany who pioneered efforts to evaluate the appropriateness of angioplasty procedures in New York State. U.S. Attorney Kerry Harvey, who handles Medicare, Medicaid and other cases in eastern Kentucky, says federal investigators use data-analysis techniques similar to those used by U.S. News to identify doctors and hospitals that merit a close look by medical experts.

The experts compare the doctor's notes and billing records with images of the patients' arteries. "We retain cardiologists," he says. "We look for people with great skills and no bias. You have these experts look at the films and compare what they see with what they see in the medical record. We steer a wide berth around medical judgment. If it's close we're going to give [physicians] the benefit of the doubt." Sampognaro performs many of his procedures at a same-day surgery center called P&S Surgical Hospital that he co-owns with 49 other physicians and a local full-service hospital.

In 2012, Medicare paid Sampognaro $1.1 million, of which $276,601 was for 729 angiographies and angioplasties. Services to patients covered by commercial Medicare HMOs or to patients under age 65 are not included, nor are copayments from Medicare patients.

The average cath-lab physician performed 99 procedures in 2012. Sampognaro asserts that the number of patients suffering from heart disease in the Mississippi Delta drives demand for his services. "We're also in the center of the most unhealthy part of the country," Sampognaro says. "People eat bad, they're overweight, the congressional district in this area is one of the poorest in the country. Everybody has coronary artery disease." Monroe's unhealthy population may partly explain why Medicare's cost per enrollee there is 35 percent higher than the national average. But the parish's health status isn't the only explanation.

Monroe ranks near the top of hospital referral regions with the highest level of "potentially avoidable hospital costs," according to the Commonwealth Fund Scorecard on Local Health System Performance.

U.S. News did a second analysis to examine whether population patterns influenced the number of procedures performed by cardiologists outside of urban areas. This analysis broke down cardiac catheterization statistics by hospital referral regions, which are geographic areas surrounding medical centers that serve as regional health care hubs. Rather than focusing on raw numbers of procedures, the second analysis calculated the procedure rate per 1,000 Medicare beneficiaries, which puts all of the analyzed areas on the same footing, regardless of population.

For every 1,000 beneficiaries in the region served by Monroe's hospitals , 59 went through cardiac catheterization lab procedures in 2012. That was double the national average and far higher than in cities that are home to major medical centers. In San Francisco, for example, the rate was 13 per 1,000 Medicare enrollees. The analysis resulted in similar findings for many other rural areas. U.S. News conducted a final analysis that adjusted the regional rates to account for the incidence of heart attack in each region in 2012. That analysis showed heart attack rates explained little of the regional variation in cardiac catheterization. Many of the rural communities with unusually high rates, including Monroe, remained outliers even after adjusting for the heart attack rate.

Dr. Christopher White, chief of interventional cardiology at the Ochsner Clinic Foundation in New Orleans, taught Sampognaro in the late 1990s during a cardiovascular disease fellowship. He says the U.S. News findings underscore the importance of making sure physicians are not exposing patients to unnecessary procedures. "Making seven figures isn't unusual for an interventional cardiologist," White says. "These guys work hard. They're putting in their 12- or 13-hour days.

The question is: Are they doing things that need to be done? Or are they widget makers, putting in widgets because that's what the system incents them to do?"

The U.S. News analysis flagged cardiologists in other communities as well. Judging from their catheterization rates, doctors in the Huntington, West Virginia, region were also among the busiest cardiologists in the United States. More than 91 of every 1,000 Medicare enrollees in the region underwent procedures in 2012-a rate nearly triple the national average. The probability that the high rates were due to random variation was less than one in 1,000. The doctor who submitted the largest bill for cardiac cath lab procedures in the region in 2012 was Dr. Richard Paulus, a prominent cardiologist at King's Daughters Medical Center in Ashland, Kentucky, an Ohio River community of 21,000, just west of Huntington, where the hospital has eclipsed the steel industry as the town's biggest employer. Paulus, who retired from the hospital in July 2014, is so closely identified with King's Daughters that the heart pavilion there carries his name.

In 2012 alone, Paulus received $305,967 from Medicare for 923 catheterizations and angioplasties. His work accounted for more than 15 percent of all of the procedures performed in the region and made him the sixth-busiest cardiac catheterization specialist in the nation. Federal investigators were so struck by the hospital's high catheterization rates that they launched a probe of its catheterization laboratory.

Last spring, the hospital agreed to pay the government $41 million to settle allegations that, between 2006 and 2011, the hospital submitted millions of dollars' worth of "false claims" to Medicare and Medicaid for performing angioplasties and implanting stents in "numerous" patients who did not need them, according to an FBI press release.

The settlement terms allowed the hospital to deny wrongdoing in the case. Paulus has not been charged. His lawyer, Robert Bennett, acknowledges that Paulus is under investigation, but asserts that his client "adamantly denies wrongdoing in this case."

Terre Haute, Indiana, ranked just after Huntington as the second-busiest region in the country for cardiac catheterization. For every 1,000 Medicare enrollees in the area, doctors performed 83 procedures. The Alexandria, Louisiana, region ranked third, with a rate of 73 per 1,000. Physicians there billed for 3,355 cath lab procedures. By contrast, in Las Vegas, a region that is home to a more than three times the number of Medicare beneficiaries, physicians billed the federal health plan for only 3,368 procedures. "In a world where everything made sense, it would be the big cities that have high-volume angioplasty centers," says Dr. Spencer King of Emory Healthcare in Atlanta, an angioplasty pioneer who reviewed the U.S. News data.

A factor that may contribute to the high rates of angioplasties is that some interventional cardiologists administer the stress tests and imaging studies that determine whether a procedure is warranted. For aggressive cardiologists, that approach has two potential benefits – it boosts their income and gives them control over interpreting the tests. One way to eliminate the conflict of interest, experts say, would be to shift responsibility for giving the green light from the interventional cardiologist who performs the procedure to the doctor who referred the patient in the first place. In most hospitals, that's not the way it works.

"The decision to do the procedure is made by the person who would benefit from the procedure," says Dr. David O. Williams, a cardiologist at Brigham and Women's Hospital in Boston.

High volumes alone don't necessarily translate into unnecessary procedures. In some cases, interventional cardiologists may perform large numbers of procedures because they serve many doctors who refer patients for specialized testing and treatment, says Dr. Gregory Dehmer, chief of cardiology at Scott & White Healthcare in Dallas. U.S. Attorney Harvey, who handled the Paulus case, agrees. "Just because you have a provider who's a statistical outlier, that doesn't mean the provider has done anything wrong," he says. " It simply raises questions. Sometimes there are completely legitimate explanation why the data is what it is." Even doctors who aren't swayed by financial considerations still wrestle daily with the challenging question of whom to treat. The ACC's National Cardiovascular Data Registry, which gathers clinical data on heart disease cases nationwide, has moved to address the issue by encouraging cardiologists to monitor their own practice patterns. Registry participation is voluntary, but the 1,600 member hospitals supply data on 95 percent of the nation's angioplasties. Doctors can explore their own procedure volumes, complications and outcomes against those of other doctors, available as benchmarked averages. They seldom do, says ACC cardiologist Dr. Ralph Brindis. "Only a small percentage of physicians have gotten the message and bother to look at their data," which have been available for about 18 months, Brindis says. The registry is prohibited by its member hospitals from making detailed physician performance data public, he adds.

Tags: hospitals , Medicare , heart surgery , Heart Health , doctors

Steve Sternberg Senior Writer

Steve Sternberg is a senior writer for U.S. News and a data journalist covering health care performance, health policy, clinical medicine and public health. You can follow him on Twitter ( @stevensternberg ), connect with him on LinkedIn or email him at ssternberg@usnews.com .

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