Law360, New York (October 20, 2017, 7:50 PM EDT) — A former Massachusetts General Hospital anesthesiologist on Thursday told a federal judge that she’s sufficiently shown in her qui tam suit that the hospital violated the False Claims Act when double-booking surgeries, even though she hasn’t been able to provide a specific bill charging the government for those patients.
Dr. Lisa Wollman, who first filed her suit in 2015, alleges that patients were treated by residents and fellows without teaching doctors supervising, in violation of Medicare rules, and then left under anesthesia unnecessarily long to wait for doctors busy with other surgeries. She urged the court to reject MGH’s motion to dismiss, saying the examples of patient surgeries are more than sufficient to prove fraud at this stage of the litigation.
“The locus of wrongdoing in this case was not the claims processing department,” Wollman said. “Here, the fraud occurred in MGH operating rooms sealed off from regular traffic. MGH’s billing personnel, who have access to all patients’ insurance information and all claims submitted to Medicare and Medicaid, are not privy to the fraudulent conduct alleged by relator. By the same token, Dr. Wollman … has no more access to the actual claims for payment than a pharmaceutical sales representative has to the claim submissions of the physicians he or she has bribed by payment of kickbacks.”
Wollman said that during her years as an anesthesiologist at the Boston hospital, procedures with the same surgeon would regularly be booked at least two at a time, leaving residents and fellows operating unsupervised, and making patients have to get extra anesthesia if they had to wait for surgeons when needed. That extra anesthesia, which is charged in 15-minute increments, constitutes unnecessary, excessive and dangerous prescribing, Wollman said.
It would be “highly implausible” that none of the thousands of patients involved in these surgeries were covered by Medicare and the state Medicaid program, MassHealth, she said.
Under Medicare regulations, fellows and residents may handle parts of a surgery alone but the surgeon must be there for “key and critical parts.” Wollman said she witnessed several surgeries where no licensed surgeon took part at any point, meaning that they couldn’t be there for those parts.
But the hospital’s motion to dismiss said that the rule is vague, allowing surgeons to decide what parts of surgeries are critical or key and therefore what they need to be in the room for and what they do not need to be present for.
The motion goes on to claim that Wollman doesn’t allege that actual claims were billed to Medicare or MassHealth. It also said that she doesn’t name a specific surgery where a physician wasn’t present for part of the surgery they defined as key or critical, and that such a claim then followed, or name an instance where two surgeries overlapped and the key or critical parts overlapped as well.
The hospital’s motion also said that Wollman’s suit fails to show that Medicare and MassHealth would have denied paying MGH if they knew about the overlapping surgeries, meaning it doesn’t meet the materiality bar set in the U.S. Supreme Court’s landmark Escobar decision.
The anesthesiologist’s opposition to the motion argues that the omissions were material, as MGH allegedly violated regulations that were conditions of payment. Wollman adds that the First Circuit has expanded on Escobar, making it clear that dismissal before discovery isn’t okay if there’s evidence that the alleged violations were material.
The government in February had said that it wouldn’t intervene in Wollman’s suit.
Representatives for Wollman and MGH didn’t immediately respond to requests for comment Friday.
Wollman is represented by Laura R. Studen of Burns & Levinson LLP and Reuben A. Guttman, Traci L. Buschner, Justin S. Brooks and Elizabeth H. Shofner of Guttman Buschner & Brooks PLLC.
MGH is represented by Martin F. Murphy, Neil Austin and Julia G. Amrhein of Foley Hoag LLP.
The case is United States of America et al v. Massachusetts General Hospital Inc. et al, case number 1:15-cv-11890, in the U.S. District Court for the District of Massachusetts.
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.”
. . .
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.”
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.
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.
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.
