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Federal prosecutors launch investigation of prominent surgeon who double-booked operations

Boston Globe | Jonathan Saltzman |

Federal prosecutors are investigating the billing practices of one of the nation’s highest-paid surgeons after a Spotlight Team report detailed that Dr. David B. Samadi ran two surgeries simultaneously on hundreds of occasions — a routine that colleagues said many patients did not know about.

Samadi, the chief of urology at Lenox Hill Hospital in Manhattan and a medical expert on Fox News, already is the focus of a state inquiry into how he handles his enormous caseload of prostate surgeries. Current and former Lenox Hill medical personnel say he typically relied on unsupervised residents who were still learning how to do surgery.

Now, the US attorney’s office in Manhattan is looking at Samadi, too. Federal law prohibits surgeons at teaching hospitals from billing Medicare for two simultaneous operations unless the doctor was present for all “critical parts.”

“My Office has an open investigation into the billing practices of Dr. David Samadi,” wrote Assistant US Attorney Jessica Jean Hu to the Spotlight Team in an unsolicited e-mail late last month seeking information from the Globe, which published a story about Samadi in March.

A spokeswoman for the office said no one would comment further on the investigation, which appears to be focusing on potential civil violations rather than crimes.

Samadi’s office referred questions about the federal probe to Lenox Hill. Barbara Osborn, a spokeswoman for Lenox Hill’s parent company, said the Globe inquiry was the first time the hospital administration had heard about it.

“Neither Lenox Hill Hospital nor its parent, Northwell Health, is aware of any federal investigation into Dr. Samadi’s billing practices,” she said.

Reuben Guttman, a Washington, D.C., lawyer who has represented clients in federal cases alleging health-care fraud, said it was extraordinary for a prosecutor to disclose an open investigation.

The e-mail to the Globe, he said, was a “clear signal that the matter of concurrent surgeries is extremely material to the payment of Medicare and Medicaid funds.”

The federal investigation of Samadi comes amid a growing national debate over an operating room practice that was largely unknown to the public until late 2015, when the Spotlight Team published a story about simultaneous operations at Massachusetts General Hospital. There, over the objections of several colleagues, a handful of top orthopedic surgeons would sometimes schedule two operations that overlapped for hours, requiring them to shuttle back and forth between rooms to tend to their unconscious patients.

MGH strenuously defended its practices and said its own review showed that patient care was never compromised. There have been few independent studies into whether double-booked surgery patients are more likely to suffer complications, and there is no definitive evidence that they are.

But since the Spotlight report, the US Senate Finance Committee has urged hospitals to more strictly enforce Medicare rules limiting the practice. And the nation’s largest association of surgeons has revised its guidelines for such surgeries, saying patients must be informed whenever doctors run more than one operating room at a time.

Lenox Hill officials previously confirmed that Samadi uses two operating rooms at once, but said he was present for the entirety of “major surgeries,” that he performs all robotic surgeries himself, and that his “primary concern and priority has always been the well-being of his patients.” Osborn, the hospital spokeswoman, had also acknowledged the investigation by the state medical conduct board and said the hospital would cooperate.

Lenox Hill data obtained by the Spotlight Team showed that Samadi overlapped one case with another at some point in about 70 percent of his roughly 2,200 operations between mid-2013 and mid-2016. Hundreds of times, one operation overlapped completely with another. Most of the overlapping cases occurred when he was doing a robot-assisted prostate operation in one room and had a conventional procedure going in a second.

Six medical personnel told the Globe early this year that urology residents do the vast majority of Samadi’s nonrobotic surgeries, including two-hour operations to trim away excess prostate tissue blocking urine flow.

In fact, residents who train in Lenox Hill’s urology department complained in an anonymous 2015 survey that Samadi wasn’t teaching them the intricacies of robotic surgery at all, according to medical personnel and a letter written by the agency that accredits residency programs, called the Accreditation Council for Graduate Medical Education, or ACGME.

In 2015 and 2016, the council gave Lenox Hill a warning when it reaccredited the urology residency program, citing the survey responses and other factors. In August of this year, the accrediting agency downgraded the program further, putting it on probation. That means the program “has failed to demonstrate substantial compliance” with ACGME requirements, according to the agency’s regulations.

Lenox Hill replaced Samadi as director of the residency program in July. Osborn said the hospital’s parent company decided it didn’t want department chairs to also run residency programs.

An ACGME spokeswoman would not specify reasons for the probationary accreditation. But a veteran urologist affiliated with Lenox Hill said it means the program is in danger of losing accreditation, which would end the use of residents by the department and mean a loss in federal funding.

“It’s a disgrace,” said the urologist, who insisted on anonymity for fear of reprisals.

Osborn, the hospital spokeswoman, said Lenox Hill only recently received ACGME’s findings and that “a specific action plan has yet to be developed.”

Samadi is one of the highest-paid surgeons in the country, earning $6.7 million in 2015 and attracting international patients and well-known personalities, such as “Today Show” host Matt Lauer. Although his website boasts gushing testimonials from satisfied patients, other patients have questioned how much of a role he really had in their operations.

Peter Nadler, a retired restaurateur in Manhattan, told the Globe last winter that he barely saw Samadi the day of his 2015 operation for an enlarged prostate, and that his libido vanished after the procedure, a known risk of the surgery. In January, he said, he confronted Samadi about whether the urologist or another doctor did the operation.

“That’s a horrible thing to say to your doctor,” Samadi replied, according to Nadler’s wife, Lorraine, who accompanied him to the meeting. Records obtained by the Globe show that Samadi had another operating room going for all but 25 minutes of Nadler’s case.

Jonathan Saltzman can be reached at jonathan.saltzman
@globe.com.

Article available on line here.

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Whistle-blower files suit over alleged double-booked surgeries

By Jonathan Saltzman and Todd Wallack – GLOBE STAFF JUNE 07, 2017

Orthopedic surgeons at Massachusetts General Hospital repeatedly kept patients waiting under anesthesia longer — sometimes more than an hour longer — than was medically necessary or safe, as they juggled two or even three simultaneous operations, according to a federal lawsuit that alleges frequent billing fraud at the prestigious hospital.

Dr. Lisa Wollman, a former anesthesiologist at Mass. General, alleges in the lawsuit that at least five surgeons endangered patients by regularly performing simultaneous surgeries. Wollman charges that the doctors also defrauded the government by submitting bills for surgeries in which they were not in the operating room for critical portions of procedures, leaving the work to unsupervised trainees.

Wollman said she witnessed surgeons performing simultaneous operations repeatedly from 2010 to 2015, when she left MGH for New England Baptist Hospital. She said hospital policy gave the doctors financial incentives to do more procedures, and they never told patients they would be going back and forth between operating rooms.

. . .

Wollman’s lead attorney, Reuben Guttman of Washington, D.C., argues that the doctors violated rules for two government health insurance programs, Medicare and Medicaid, which require surgeons to be present for all “critical portions” of an operation in order to get paid. If surgeons weren’t present and billed the insurers without making their role clear, it could constitute billing fraud, though the rule has seldom been enforced.

. . .

Guttman, Wollman’s attorney, said it was premature to talk about the damages if Mass. General is found to have improperly billed Medicaid and Medicare, but the costs could be considerable. The law calls for treble damages and Mass. General could face an additional penalty of at least $5,000 for each instance of improper billing, Guttman said. If Wollman prevails, he added, she could potentially receive 25 percent to 30 percent of any money recovered under the False Claims Act.

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Celgene to Pay $280 Million to Settle Fraud Suit Over Cancer Drugs

The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.

Under the terms of the settlement, which resulted from a lawsuit filed by a whistle-blower — a former sales representative at Celgene — the company will pay $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia.

. . .

“The company got the idea that it could be fast and loose with what it was saying about its drug because it was selling to cancer patients who might be in need,” Mr. Guttman said. “At the end of the day, what this is about is that even when you’re on life’s edge,” he added, a company “can’t break the law by off-label marketing a drug.”

. . .

The settlement was reached after federal prosecutors declined to intervene in the case, although they continued to monitor it. Under the federal False Claims Act, private citizens like Ms. Brown can bring a suit against companies in the United States and share in any recovery. The amount of her reward has not yet been determined, Mr. Guttman said.

. . .

Read the full story here.

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Celgene to Pay $280 Million to Settle Fraud Suit Over Cancer Drugs

New York Times | By Katie Thomas |

The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.

Under the terms of the settlement, which resulted from a lawsuit filed by a whistle-blower — a former sales representative at Celgene — the company will pay $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia.

The Celgene settlement is the latest in a string of multimillion-dollar fines that pharmaceutical companies have paid to settle charges that they inappropriately marketed certain drugs in recent years, but this case is one of the largest settlements to involve a cancer drug, said Reuben A. Guttman, who represented the whistle-blower, Beverly Brown.

Cancer drugs are seen as more difficult to pursue in so-called off-label marketing cases in part because oncologists often prescribe drugs for unapproved uses in an effort to combat a deadly and still mysterious disease.

“The company got the idea that it could be fast and loose with what it was saying about its drug because it was selling to cancer patients who might be in need,” Mr. Guttman said. “At the end of the day, what this is about is that even when you’re on life’s edge,” he added, a company “can’t break the law by off-label marketing a drug.”

Brian Gill, a spokesman for Celgene, which is based in New Jersey, said in a statement on Tuesday that the company denied any wrongdoing and said it was “settling to avoid the uncertainty, distraction, and expense of protracted litigation.”

He noted that, before the settlement, a federal judge had dismissed a portion of the case that claimed that Celgene had illegally paid doctors to induce them to prescribe Thalomid and Revlimid, and he said that the company stood by the significance of its drugs, which he described as “breakthrough medicines.”

By 2016, Revlimid, which was closely related to Thalomid, was Celgene’s leading product, bringing in nearly $7 billion in sales. Thalomid’s sales in 2016 totaled $152 million, according to the company. The company’s shares were down 1 percent at the close of the stock market on Tuesday.

The settlement is the most recent chapter in the story of thalidomide, the notorious drug that was developed by a German company and marketed around the world in the 1950s as a sedative and anti-nausea treatment. In the 1960s, following discoveries that the drug caused horrific birth defects, thalidomide was pulled from pharmacy shelves worldwide. Although the drug was not approved in the United States, the thalidomide crisis led to the overhaul of the nation’s drug-approval process, including the requirement that companies prove a drug is not just safe but also effective.

In 1998, the Food and Drug Administration approved it for use in patients with a complication of leprosy, albeit with severe restrictions intended to prevent it from getting into the hands of pregnant women. Celgene called it Thalomid. Even though it was approved for a rare condition, many in the medical community expressed hope it could soon be used to treat a broader range of conditions, from cancer to autoimmune diseases and AIDS, according to news reports.

Sales of Thalomid quickly took off, in part because — as Ms. Brown claimed in her complaint — Celgene “flooded the country” with sales representatives who were under heavy pressure to pitch the drug to oncologists for a variety of cancers. The F.D.A. sent Celgene two warning letters, in 1998 and 2000, claiming the company had been marketing the drug to treat cancer. In 2000, one Wall Street analyst estimated that 90 percent of Thalomid’s sales were to treat cancer, according to Ms. Brown’s complaint.

Doctors have leeway in deciding which drugs to prescribe, but pharmaceutical companies are supposed to promote their products only for uses that are approved by the F.D.A.

Celgene did not gain approval to market Thalomid as a cancer treatment until 2006, when the F.D.A. cleared it to promote the drug for multiple myeloma.

In 2005, even before Thalomid received its approval for use in cancer patients, it was Celgene’s leading product, bringing in $387.8 million in net sales, according to the company’s financial statements.

Also in 2005, the company received approval to sell Revlimid for a rare cancer, and Ms. Brown’s complaint claims that the company — as it had with Thalomid — marketed it to treat a broader range of cancers. It also pressured doctors to switch Thalomid patients to Revlimid, which is more expensive.

Ms. Brown’s complaint also claimed that Celgene’s inappropriate marketing of Thalomid exposed patients to heightened risks that included potentially fatal blood clots and other side effects. Those risks were added to the drug’s warning label only after it received the approval for cancer treatment, Mr. Guttman said.

The settlement was reached after federal prosecutors declined to intervene in the case, although they continued to monitor it. Under the federal False Claims Act, private citizens like Ms. Brown can bring a suit against companies in the United States and share in any recovery. The amount of her reward has not yet been determined, Mr. Guttman said.

Celgene is expected to pay the settlement on Wednesday, the Justice Department said.

Article also available on line here.

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Whistle-blower files suit over alleged double-booked surgeries

By and
The Boston Globe

Orthopedic surgeons at Massachusetts General Hospital repeatedly kept patients waiting under anesthesia longer — sometimes more than an hour longer — than was medically necessary or safe, as they juggled two or even three simultaneous operations, according to a federal lawsuit that alleges frequent billing fraud at the prestigious hospital.

Dr. Lisa Wollman, a former anesthesiologist at Mass. General, alleges in the lawsuit that at least five surgeons endangered patients by regularly performing simultaneous surgeries. Wollman charges that the doctors also defrauded the government by submitting bills for surgeries in which they were not in the operating room for critical portions of procedures, leaving the work to unsupervised trainees.

Wollman said she witnessed surgeons performing simultaneous operations repeatedly from 2010 to 2015, when she left MGH for New England Baptist Hospital. She said hospital policy gave the doctors financial incentives to do more procedures, and they never told patients they would be going back and forth between operating rooms.

“This often meant an unwitting patient was left fully anesthetized — unconscious, paralyzed, intubated, dependent on a ventilator to breathe — for longer than medically necessary, often in the care of trainees, without the backup of a properly qualified surgeon, despite legal requirements,’’ said the suit filed Wednesday in US District Court in Boston.

Mass. General has previously disputed the validity and importance of virtually every complaint about surgeries that overlap, saying there’s no evidence any patients have been harmed. On Wednesday, Mass. General released a statement defending its approach to surgery: “The MGH continues to believe that its practices comply with all applicable laws and regulations, and the hospital will defend the claims accordingly.”

The lawsuit is believed to be the first filed by an MGH physician in the wake of a controversy that roiled Mass. General for years and prompted a national debate over safe surgical practices. Though many surgeons schedule operations to overlap by a few minutes — letting trainees close the surgical wound of the first operation while the surgeon moves on to the second — the debate at Mass. General focused on surgeries that overlapped for much longer.

There’s been relatively little research into the safety of simultaneous surgery, though a University of Virginia researcher found no increase in complications in operations that overlapped by up to 45 minutes. The American College of Surgeons last year issued its first-ever guidelines saying the practice is broadly permissible, within limits, but that “the patient needs to know” whenever a doctor runs more than one operating room at a time.

Wollman listed 16 dates from 2011 to 2013 when five orthopedic surgeons performed at least two operations simultaneously for hours. In every case, the suit said, patients lay under anesthesia longer than was warranted, increasing the risk of complications and inflating anesthesia charges.

Many of the allegations in the 54-page complaint were reported by The Boston Globe Spotlight Team in October 2015 in the first in a series of stories about the double-booking at MGH and other teaching hospitals. Wollman was among several doctors who criticized the practice to hospital leaders in meetings and in e-mails later obtained by the Globe.

The hospital dismissed the orthopedic surgeon who led the opposition to double-booked surgeries, Dr. Dennis Burke, for allegedly violating hospital policy by providing the Globe with internal records. Burke argued that he was fired for blowing the whistle on double-booking.

Wollman’s lead attorney, Reuben Guttman of Washington, D.C., argues that the doctors violated rules for two government health insurance programs, Medicare and Medicaid, which require surgeons to be present for all “critical portions” of an operation in order to get paid. If surgeons weren’t present and billed the insurers without making their role clear, it could constitute billing fraud, though the rule has seldom been enforced.

Wollman initially filed the lawsuit under seal in May 2015. It was recently unsealed after Carmen M. Ortiz, who was US attorney at the time, and state Attorney General Maura Healey declined to join the suit as plaintiffs. Wollman filed a revised version of the suit Wednesday, telling the Globe in a statement released by her lawyer that she decided to pursue it without government help because she wants to end a practice “based on deception and driven by economic benefit.”

“I am pursuing this case because my ethical obligation is to patients — past, current, and future — who are unknowingly scheduled for concurrent surgeries,” said Wollman, who worked at Mass. General, Harvard’s largest teaching hospital, for more than 20 years.

Both the US attorney’s office and Healey’s office declined to comment on Wollman’s suit.

The lawsuit, which names MGH and its parent company, Partners HealthCare System, as defendants, uses pseudonyms for five orthopedic surgeons who allegedly supervised simultaneous surgeries and, in Wollman’s view, defrauded the federal and state governments in the Medicare and Medicaid programs. But the Globe was able to identify several of the surgeons based on earlier reporting.

One of the surgeons appears to be Dr. Jon J.P. Warner, chief of MGH’s shoulder service and the highest compensated employee at the hospital about a decade ago, earning just over $2.1 million one year, according to financial documents filed by the hospital. Wollman’s suit said Warner, identified only as “Surgeon A” in the lawsuit, regularly booked two simultaneous operations in the morning and two in the afternoon.

One morning in October 2011, the suit said, a 65-year-old patient on blood pressure medication waited under anesthesia for a full 90 minutes before Surgeon A arrived from another operating room to start the patient’s surgery. The suit said Surgeon A had scheduled the two long shoulder operations to start within 15 minutes of each other.

Yet, the suit said, Warner wrote on the patient’s operative note that he participated in the entire surgery. Wollman complained to hospital officials at the time, the suit said, and Warner corrected his report.

On another occasion, one of Warner’s patients lay waiting for him anesthetized when a second surgical patient asked Wollman if she could see Warner, the suit said. It turned out that Warner was in another building on the MGH campus seeing other patients, the suit alleges.

Warner, described by the hospital as one of the nation’s foremost shoulder surgeons, could not be reached, but in the past has declined to discuss specific cases to protect patient privacy.

In general, Warner wrote in a 2015 statement to the Globe, “The suggestion that I am not managing all my patients’ care while they are in the operating room is both untrue and malicious.”

Warner noted he always performs the key components of surgery and that fellows occasionally do “noncritical activities,” such as positioning and making the initial incision.

Wollman said another doctor, identified as Surgeon B, “never appeared in the room” for an April 2013 operation when he was supposed to be the attending physician and she provided the anesthesia. Based on e-mails cited in the lawsuit that are identical to ones obtained by the Globe, Surgeon B appears to be Dr. Malcolm Smith.

Wollman said the patient suffered a serious and sudden constriction of the airways while Surgeon B was not present, though a senior trainee was. The lawsuit said that Wollman complained to the operating room director about Surgeon B’s absence, writing, “Isn’t he obligated to be there?”

But Wollman said senior medical officials at Mass. General did not follow up on her concerns “except to threaten her by saying that she had violated patient privacy and could face legal action.”

Smith could not be reached for comment, but he has previously said he did nothing improper and declined to comment on individual cases. In 2015, he told the Globe in a statement that allegations that he did not take proper care of his patients were based on “innuendo, incomplete and inaccurate data.”

But Wollman claims that incidents like the one involving Surgeon B both were frequent and continued long after the hospital placed more limits on overlapping surgeries in 2012.

“The practice of billing for unreasonable and unnecessary anesthesia was not a remote occurrence” among orthopedic surgeons, the suit says. “Rather, it was commonplace and a direct outgrowth of the concurrent surgery practice which, to succeed, required patients to be put under general anesthesia waiting for their surgeon to arrive.”

Guttman, Wollman’s attorney, said it was premature to talk about the damages if Mass. General is found to have improperly billed Medicaid and Medicare, but the costs could be considerable. The law calls for treble damages and Mass. General could face an additional penalty of at least $5,000 for each instance of improper billing, Guttman said. If Wollman prevails, he added, she could potentially receive 25 percent to 30 percent of any money recovered under the False Claims Act.

cf  www.bostonglobe.com

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