It is not a anti-pro stent article, nor anything per se to do with CCSVI or the treatment
thereof, what it does show however, that no matter the niceties or
bedside manners, we as patients need to always be diligent, ask
questions, and watch out for ourselves and each other.
Cath labs = cash cows for hospitals, clinics and doctors. In this particular
instance, a Dr. supremely underqualified was doing major treatments, and
the warnings by nurses were unheeded, because admins in rural locales
would do anything and promote anyone to keep those labs going.
Many issues to address in the article, too numerous to mention.
Sorry but sometimes the medical community is just downright evil
when it comes to the bottom line, period. Us guinea pigs need to keep
our collective head on a swivel.
Mother Dies Amid Abuses in $110 Billion U.S. Stent Assembly Line
Najam Azmat snaked a catheter on a guide wire into Judi Gary’s groin as he tried to insert a stent in an artery supplying blood to her pelvis and right leg.
On an X-ray monitor near where Gary lay, nurses saw blood leakages. The wire seemed to be in the wrong place, nurse Evan Gourley told Azmat. Everything was fine, the vascular surgeon replied. It wasn’t.
A stent body is attached to graft material. Stents, metal mesh devices that prop open clogged blood vessels, have been implanted via catheters in seven million heart patients over the last decade. Photographer: Alan Petersime/MCT via Getty Images
Like many rural hospitals, Satilla Regional Medical Center in Waycross, Georgia, has to pay “higher than average physician compensation due to pressures to recruit to the area,” according to a 2011 report prepared for Georgia’s attorney general. Photographer: Sydney P. Freedberg/Bloomberg
In November of 2005, surgeon Najam Azmat tore an artery supplying blood to Norman Wayne Copeland’s left leg during a stent procedure. Source: Family photo via Bloomberg
Azmat tore Gary’s aorta during the December 2005 procedure, according to documents filed with a U.S. Justice Department civil complaint. Nurses asked another surgeon to step in. Gourley left in disgust. Later, he went to administrators at Satilla Regional Medical Center in Waycross, Georgia, with a warning about Azmat.
“I told them that he will kill a patient if they let him continue to work,” Gourley said. Officials at the Satilla hospital got at least seven similar warnings about Azmat, according to another nurse’s notes.
They let him continue. One of his next patients died.
Azmat’s tenure at the 231-bed hospital, as described in interviews and more than 1,000 pages of medical records, internal documents and witness statements that were made public last year, shows the extremes one hospital went to in order to keep its catheterization clinic -- or “cath lab” -- operating and producing revenue.
Other hospitals paid millions in kickbacks -- using ghost jobs, padded fees, debt forgiveness or discounted office space -- to induce doctors to keep up the pace in U.S. medicine’s binge on stents, according to allegations made in five federal cases and three other private whistle-blower lawsuits.
Stents, metal mesh devices that prop open clogged blood vessels, have been implanted via catheters in seven million heart patients over the last decade -- perhaps as many as one-third of them needlessly, according to David Brown, a cardiologist at Stony Brook University School of Medicine in New York. In all, 11 hospitals have agreed to settlements with the Justice Department, resolving civil allegations of needless stenting and related wrongdoing.
Earlier in This Series
Deaths Linked to Cardiac Stents Rise as Overuse Seen
Needless Stents Alleged at Kentucky Hospital Amid 2-Year Probe
Mapping America's Coronary Stent Hot Spots
Most of these federal lawsuits, typically filed by whistle-blowers under seal, have slowly been made public since 2009. They, along with dozens of interviews with patients and doctors, reveal that hospitals benefited financially while overlooking -- or even encouraging -- allegedly inappropriate stent use.
At Satilla, Azmat punctured the wall of Ruth Minter’s right kidney while trying to insert a stent in an artery near the organ in January 2006. She died 17 days later of complications from heavy blood loss, the federal complaint said. The procedure “was not medically indicated,” according to a Justice Department expert’s report.
“People who should have and could have saved Mrs. Minter’s life were too interested in having Dr. Azmat continue to do procedures and make money for the hospital to do the right thing,” said surgeon Harold Kent, who reviewed Minter’s care for a lawsuit her family filed against the doctor and the hospital.
Satilla officials denied that they kept Azmat on the job in order to make money for the hospital’s cath lab, and said his services were both needed and valuable to patients.
“The number one concern of Satilla and the administration was patient safety,” said Joseph P. Griffith Jr., an attorney who represented the hospital and its chief administrator.
The hospital agreed to pay $840,000 to resolve the Justice Department’s complaint that it submitted claims for cath-lab services -- some of them unnecessary -- that Azmat was neither qualified nor properly credentialed to perform. The hospital admitted no wrongdoing.
Azmat declined to be interviewed for this story. He denied in court filings that he caused the death of Ruth Minter.
The flood of money poured into cardiac stents -- at least $110 billion for procedures over the last decade -- can lead to “corrupted practices,” said William Hsiao, a health-care economist at Harvard University.
Cardiovascular services, including stents, open-heart surgery and other procedures, can account for as much as 40 percent of net revenues in many hospitals, said Vikas Saini, president of the Lown Institute, a neighboring Brookline, Massachusetts-based group that works to extend health care to needy people and limit unnecessary treatments.
“The cath lab is like a boiler room -- the place that makes everything else go” in a hospital, said Saini, a cardiologist. “Hospital administrators will tell you that they don’t make the medical decisions, they don’t decide who gets a stent … ‘It’s our doctors who do that.’ But they have no incentive to scrutinize the behavior and appropriateness of what the doctors are doing. They have every incentive to look the other way.”
Cath labs and similar facilities will generate about $20 billion in billings this year as cardiologists and other specialists evaluate and treat about 4 million patients’ arteries, veins and valves via the long plastic tubes, said Brian Contos, executive director of research for the Advisory Board Company, a health-care consulting group.
Few dispute the benefits of coronary stents when they’re used to restore blood flow in heart-attack patients. Since 2007, when a national study found that coronary stents added no benefit over medicines, exercise and dietary improvements for stable heart patients, their use has declined. Last year, sales of the devices fell 5 percent to $5.5 billion. Meanwhile, sales of so-called peripheral stents, used to increase blood flow in vessels that serve such areas as the legs or kidneys, has increased -- by 8 percent last year to $2.1 billion, according to Health Research International, an industry consultant.
Still, as of 2011, coronary stent procedures were being performed at 1,653 sites in the U.S., Contos said -- up 58 percent from 1998.
In seeking to keep their labs bustling, some hospitals offered cardiologists no-show jobs, according to federal lawsuits.
In Erie, Pennsylvania, Tullio Emanuele said he had just started working as a cardiologist for a group called Medicor Associates in 2001, when his new boss asked him to become a medical director at Hamot Medical Center under a $75,000-a-year contract. Emanuele, a native of Italy who attended medical school in Rome, said he found the post had few responsibilities.
“My duties were just a few hours a month preparing for a meeting,” he said in an interview. He suspected something was wrong when a Medicor clerk asked him to sign timesheets that were already filled out and inflated his hospital hours, he said.
His “sham” contract was just one of several between Hamot and Medicor that Emanuele says were designed to induce a steady stream of patients for the hospital’s cath lab, according to a whistle-blower complaint he filed under the federal False Claims Act last November. The law gives people the right to seek to recover money on behalf of the U.S. government in cases of overpayment. The Justice Department has declined to join Emanuele’s complaint, which is pending in federal court.
Emanuele, who worked for Medicor until 2005, said he found cases in which stents were inserted in patients without significant heart disease. One, identified in his complaint only as A.R., died of complications from a needless cardiac catheterization in 2004, according to his lawsuit.
Officials for Hamot, which was purchased in 2011 by the University of Pittsburgh Medical Center, declined to comment, spokeswoman Caroline Manino said. Neal Devlin, an attorney for Medicor, also declined to comment.
In legal filings, Medicor said its medical directorships at Hamot were “legitimate and legal” and denied that any of its physicians accepted kickbacks or performed unneeded procedures. Hamot denied paying kickbacks or engaging in any unlawful relationships with physicians to induce patient referrals.
The cardiologists at EMH Regional Medical Center in Elyria, Ohio, built their heart business by ‘recycling patients’ -- that is, doing repeated procedures, including stents, on the same patients in the hospital’s cath lab -- according to a whistle-blower lawsuit filed by Abdul Wattar, a cardiologist, and unsealed in January.
“I’ve seen patients with an astonishing number of stents that I hadn’t heard before, sometimes exceeding 20 stents,” Wattar said in a deposition. From 2004 to 2009, he worked with a practice called the North Ohio Heart Center, which pressured him and others to refer patients to EMH’s cath lab, he said.
In January, the hospital and the cardiology group agreed to pay the U.S. $4.4 million to settle allegations that they billed Medicare for unnecessary stents from 2001 to 2006. Both deny wrongdoing and say they acted within established practice. EMH has fewer inappropriate stent cases than the average hospital, said Stephen Sozio, an attorney who represented the hospital in the federal lawsuit.
“The plaintiff’s allegations in these cases had no merit,” said John Schaeffer, the president of North Ohio Heart, in an e-mailed statement. “We made the best medical decisions available then, and we continue to do that now.”
“It was like an assembly line,” said Geraldine Koehler, whose mother, Margarette Kerrigan, was a repeat patient. Kerrigan, 77, died of massive internal bleeding 10 hours after North Ohio Heart’s leading cardiologist, Charles O’Shaughnessy, inserted two stents in 2003, an autopsy report and medical records show. O’Shaughnessy declined to comment, said Gary Zrimec, North Ohio Heart’s chief executive officer.
In another whistle-blower suit unsealed in January, Kenny Loughner, the former manager of EMH’s cath lab, said he saw O’Shaughnessy and another North Ohio Heart doctor “routinely instruct EMH nurses and technicians involved in the procedures to record fictitious and non-existent complaints of chest pain” or falsify heart-monitoring records to justify needless operations.
An expert hired by the U.S. Attorney’s Office independently determined that “false statements” were recorded in some medical records to justify procedures, according to a memo from the U.S. Department of Health and Human Services’ Office of Inspector General.
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