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Health-Care Fraud: Keep an Eye on the Small Fry
Opinions | 2008/03/11 13:01

You might have been afraid to attend the American Bar Association’s white-collar crime conference last week. But the Health Blog, armed with the First Amendment, endured the topic and the tropical clime of Miami to check out a panel on health-care fraud.

The government and the corporate defenders were there. Big Pharma bogeywoman Susan Winkler, chief of the health-care fraud unit at the U.S. Attorney’s Boston office, shared the dais with defense attorneys Ty Cobb, Nicholas C. Theodorou, Katherine Lauer and Thomas Dwyer.

The group ran though the health-fraud hit parade: off-label marketing, assessing the value of a case and how a company, once cornered, can strike a productive note with the feds.

But the thing that jumped out at us was the group’s consensus that smaller companies–biotechs and device companies—are expected to be the next big hunting ground for fraud and wrong-doing. “Small cap companies, biotech and medical device companies, their resources are limited in terms of compliance,” Theodorou said. And, he added, “they’re very sales and marketing driven.”

Winkler agreed, saying, “We’re going to see more and more off-label with medical devices.” The U.S. Attorney’s office in Boston has been a leader in rooting out health- care fraud, including cases against a host of drug companies. Sketchy pricing schemes and off-label marketing, or pitching a drug for uses beyond those approved by FDA, have been regular fraud fodder.

But Big Pharma, said the panel, has learned from its lumps after battling government investigations and charges. “There are a lot of drug executives walking around with huge dents in their heads,” Cobb said. “They’ve been beaten with rules and compliance.” It’s the little guys, particularly single-product companies, who don’t have the resources and infrastructure to set up checks and balances. The legal stakes can break a company, Cobb said. “I got a case where the first person I called wasn’t the forensics guy, but the bankruptcy guy.”





Doctor-lawyer project tackles malpractice
Opinions | 2008/03/04 03:23

Doctors and lawyers in Montgomery County are doing something unusual: working together.

Members of the county's bar association and medical society, along with Abington Memorial Hospital, tomorrow are launching a pilot project they hope will keep more malpractice disputes out of court.

Lawyers and doctors will work in teams to mediate conflicts between patients and the hospital or doctors. The hope is that the new approach will resolve problems more quickly and humanely, without the demonization of both sides that can occur in malpractice battles.

Whether it will save money remains to be seen. Project leaders say that is not the primary goal.

John J. Kelly, Abington Memorial's chief of staff, said he wanted to avoid the "harshness" of litigation. "At the end of the day, I think everybody walks away feeling like it's a much more productive process, and it's a healing process," he said of mediation.

"I think litigation makes everything so much more painful for everyone, and I'm not sure healing ever occurs."

Planning for the project started three years ago after a nudge from the state Supreme Court. It encouraged counties to look at alternatives to traditional court battles as doctors threatened to leave Pennsylvania because of skyrocketing malpractice-insurance rates. Not much has happened elsewhere in the state, but doctors and lawyers here pursued it because "there's got to be a better way to do things than the way we've been doing them," said Mark Lopatin, a rheumatologist, who led the medical society's part of the effort.

People on both sides say the current system is emotionally draining, even when you win.

"Clients hate courtrooms," said Robert Morris, president of the Montgomery County Bar Association. "I haven't ever had a client that wanted to get in the witness stand."

The project deals with unhappy patients and their families through a two-step process. In the first, doctors and nurses at Abington have been trained to listen to such patients and explain what happened in as much detail as possible. Project leaders say many people who sue do so primarily to find out what happened.

If that is not enough, patients can move to mediation, a process that helps them hammer out a settlement with their doctors. The mediator shuttles between the sides, bringing their positions together. Unlike a judge or arbitrator, the mediator does not decide the case. Instead, the patient and doctor - or more likely their attorneys - determine an acceptable outcome. Usually that involves money, but patients also often want an apology and assurance that steps will be taken to prevent future mistakes.

If the sides are still fighting, patients still have the option of going to court.

In this region, Drexel University College of Medicine's doctors have the longest-running mediation program. Theirs often uses a team approach, pairing lawyers who typically represent patients with those who defend doctors. Abington's new program creates even more unusual teams. A lawyer with health experience will be the lead mediator, and a doctor will be his "medical partner."

"It's precedent-setting, this project," said Jane Ruddell, a former health-system lawyer who now runs a company devoted to alternative dispute resolution. "It's really trying to change a culture."

Ruddell ran a training session last week in the bar association's Norristown office to train about 30 doctors and lawyers to be mediators. Many of the lawyers had previous experience with mediation, but the daylong program was an eye-opener for the doctors, who understood for the first time how hard and time-consuming it was to sort through strong emotion and find common ground.

In a training exercise, the doctors and lawyers were split into groups for some role-playing. Abington Memorial obstetrician-gynecologist Robert Michaelson played the mediator for one. The bar association's Morris was an angry woman with cancer, and Mark Pyfer, president of the Montgromery County Medical Society, was her even angrier husband.

The patient in the case had had foot pain, which the doctor thought was caused by a pinched nerve. The patient decided not to have surgery the doctor recommended and later lost part of her leg after the cancer was discovered.

Michaelson got into trouble almost immediately, waiting too long to separate the warring parties. He ran out of time without getting close to a settlement, but Morris, who is a trained mediator, and Pyfer, a novice, proved a good team.

"I thought she was negligent because she never paid much attention to me," Morris said petulantly.

"Dr. Reynolds can say she's sorry, but I don't think she has any idea what it's like to go through life with one leg," Pyfer chimed in. Then he asked for $10 million.

Doctors came away from the experience understanding why the lawyers will take the lead in mediations, at least in the beginning.

"The most striking thing about this was . . . how difficult this is," said Lopatin, the rheumatologist.

Frank Murphy, a lawyer who attended the training, said it might be harder than the hospital anticipated to avoid malpractice filings and to persuade lawyers to be totally open with one another. Legal-filing deadlines, strategy, and payment agreements give lawyers an incentive to file in court and, sometimes, to stretch out the proceedings.

Advocates of mediation say it is often cheaper than court because there are fewer exhibits and medical experts to pay for.

Participants usually sign confidentiality agreements, a step that supporters say spares everyone embarrassment. The downside of the secrecy is that mediated cases create no legal precedent and leave no public record. Monetary settlements are reported to the National Practitioner Data Bank. But its information is available only to hospitals and professional groups, not consumers.

Some doctors also worry that mediation will be just one more step on the way to court. That has not been Drexel's experience. Of 40 cases that have gone to mediation, only three were unresolved.

Those involved in the Montgomery County experiment say it is more likely to give patients what they really want: early action, an apology, and information. "Patients want answers. That's what they want more than anything," said Sheila Stieritz, a former director of patient safety at Abington Memorial, who consulted on the pilot project. "And if it's something really serious, most patients want it not to happen to anybody else."



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