Eon Labs Inc. will pay the federal government $3.5 million to settle False Claims Act allegations raised in a whistleblower suit relating to drug maker's Nitroglycerin Sustained Release capsules, the Justice Department announced today.
The FDA ruled in 1999 that Nitroglycerin SR had unproven effectiveness and issued a notice to withdraw approval of the drug, which made it no longer legally eligible for Medicaid reimbursements, DOJ said in a media release.
DOJ alleges that from April 1999 through September 2008, Eon submitted false quarterly reports to the government that misrepresented Nitroglycerin SR's status and failed to report that Nitroglycerin SR no longer qualified for Medicaid reimbursements. As a result, DOJ contends, Eon knowingly submitted fraudulent Medicaid claims.
Eon Labs is a subsidiary of Sandoz Inc., which is a subsidiary of Novartis AG.
"This is the first False Claims Act agreement with a drug company that sought to charge the government for less than effective drugs, and it shows that the Department of Justice will pursue those who market such drugs and expect the government to pay for them," said Carmen Ortiz, US Attorney for the District of Massachusetts, in a media release.
The settlement resolves allegations against Eon in the multi-defendant whistleblower suit United States ex rel. Conrad v. Eon Labs, Inc., et al. Under this settlement, the whistleblower will receive approximately $525,000, DOJ said.
"We expect manufacturers to be truthful about the regulatory status of their drugs, and we will pursue those companies that submit false information to obtain payment for unapproved drugs that are less than effective or on the market illegally," said Tony West, assistant attorney general for the Civil Division, in a media release.
DOJ said it has used the False Claims Act One to recover approximately $2.2 billion in cases involving fraud against federal healthcare programs since January 2009.
When asked to comment on the case, Eon responded with a one-sentence statement: "Eon Labs has reached a settlement with the federal government bringing final closure to the lawsuit regarding Nitroglycerin SR capsules."
If your employee wellness program offers smoking cessation classes, encourages moderate physical activity, and provides healthy food options in the cafeteria, you're on the right track. If the focus of your wellness program is weight loss, however, you're wasting time and money, and maybe even endangering your employees' health. So says Paul Campos, a professor of law at the University of Colorado, and the author of The Obesity Myth: Why America's Obsessions with Weight is Hazardous to Your Health.
"I'm all for encouraging people, including employees, to be physically active, because that has been shown to have all kinds of beneficial health effects," Campos tells HealthLeaders Media.
"But focusing on making people thinner makes no sense, because all the evidence on physical activity illustrates that people gain benefits from physical activity regardless of whether they lose weight in the long term. The vast majority of cases, of course, don't lose weight in the long term, but they still get the benefits of improved physical activity," he says. The weight loss goal is completely unnecessary, which is great news when you consider that it is unsustainable for somewhere from 95% to 98% of the people who try to."
Campos has emerged as a gadfly in the war on fat as a public health menace. He doesn't buy the argument that the nation is facing an obesity epidemic. He notes, for example, that obesity rates for adults and children have leveled off over the last decade.
Two weeks ago, when First Lady Michelle Obama was in the media mounting a campaign against childhood obesity, Campos urged her to "stop picking on fat kids."
Campos says the First Lady's campaign shows that it's socially acceptable to target overweight people. "Don't underestimate the effect of social prejudice here," he says. "It's OK to slam fat people because they are the disfavored group and essentially they are folk devils for whom all these social ills are being dumped on at this particular moment."
If employers want to reduce healthcare costs, he says, they could save more money by targeting other groups instead of the overweight and obese. "Don't hire men because men have much worse health profiles than women. Don't hire anybody over 40, because by far the best predictor of healthcare costs is aging," he says. "You can't do that because it's illegal, but you can threaten to not hire fat people because it's perfectly legal."
Campos says it is true that Americans are bigger and heavier now than they were a generation ago, but he said nobody knows exactly why that is the case. "Here is what we do know: Americans are healthier now than they have ever been before by every possible objective metric," he says. "Not only is life expectancy longer, but rates for almost every major chronic disease are lower and mortality rates for those diseases are lower and rates of disability are lower. We are healthier than we have ever been before but there is apocalyptic nonsense that we have a catastrophe because people are getting fat."
Campos calls wellness programs that stress weight loss the product of "a trickle down effect of all this junk science."
"Do fat employees need to be told they are fat? Is this a valuable piece of information that HR is going to convey to them?" Campos asks. "I have been studying this issue for 10 years and I have never found a middle or upper class white woman in the United States who is above average weight who doesn't know it and wants to lose weight."
"So, the problem is what, a lack of information, not trying hard enough? That is crazy," he says. "You have this moral panic and hysteria and you can say the same idiotic things over again and nobody gets called on it. This is just reefer madness, or satanic ritual abuse in our preschools or whatever nonsense we are preaching, all over again."
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The quick acquittal earlier this month of Texas whistleblower Anne Mitchell, RN, has nursing organizations relieved, but also pressing ahead with remedies to prevent a similar case.
Alice Bodley, general counsel for the American Nurses Association, says only 22 states have whistleblower protections "specifically geared toward healthcare workers."
"We would want to see established in every state to the extent possible a federal law, with very strong prohibitions against retaliation for whistleblowers. That is not only in the nurses' interest, but the patients' as well," Bodley says.
She says it might be time to extend federal whistleblower protections to healthcare professionals who identify not just financial irregularities but also unsafe healthcare practices related to Medicare or Medicaid.
"There are protections for disclosure of violations of Medicare laws, qui tam protections, but they are generally not designed to get to the question of professional practice. It's more financial in terms of Medicare payments," she says. "CMS and the federal government are now moving toward quality measurements through the federal reimbursement system, and this is definitely something we can look at."
Bodley says whistleblower protections have historically been crafted at the state level, but that nursing associations should approach the issue "from every possible vantage point." "The fact is the state laws as they exist now to protect healthcare workers vary widely in terms of the scope of protections and the procedures that are in place," she says. "To the extent that we can obtain a national law that would protect whistleblowers who come forward to disclose poor quality healthcare in connection with Medicare issues, that would be great."
Mitchell was charged with and ultimately acquitted of "misuse of official information," a third-degree felony, for reporting Rolando Arafiles, MD, to the Texas Medical Board. Prosecutors said the nurse violated patient confidentiality when she included their case numbers in her complaint to the medical board. Had she been convicted, Mitchell could have faced up to 10 years in prison. However, after a four-day trial, a state jury in Andrews, TX, needed less than one hour to acquit Mitchell.
Ironically, Texas has some of the strongest whistleblower protection laws in the nation, which was underscored by the "misuse of official information" charges against Mitchell. Texas Nurses Association General Counsel and chief lobbyist Jim Willmann says Mitchell and codefendant Vicki Galle, who had her charged dropped before the trial, were protected by whistleblower statutes, which forced the prosecutors to get creative.
"It's narrower than that," he says. "They were able to go after them only because it was a public hospital and the nurses were county employees. The misuse of official information applies only to public service."
Had the nurses been employed at a private, not-for-profit hospital, Willmann says, "I don't think they'd have found anything else they could have charged them with."
"The prosecutors looked at the initial complaint, which was harassment, and when they found they couldn't make that complaint stick they looked around and found this misuse of official information," he says. "It's hard to figure out how this could be a misuse of official information if it is shared with a regulatory oversight agency."
Willmann says TNA will go to the Texas Legislature when it next meets in 2011 to seek a remedy. "We are just beginning to sort it out," he says. "It's hard to come up with an easy way to limit prosecutorial discretion. We are dealing with what I would characterize as an abuse of prosecutorial discretion, and that may be hard to draft into law."
As for Mitchell and Galle, who lost their jobs during the criminal investigation, they have filed a civil lawsuit in federal court against Arafiles, Winkler County, Texas, the county-owned hospital, the sheriff, and the prosecutor, alleging that the criminal prosecution was baseless and vindictive and a violation of their First Amendment rights.
The union representing 5,000 nurses, doctors, and other healthcare workers at Jackson Health System in Miami has asked a state grand jury to investigate alleged mismanagement that union officials say has the public hospital on the brink of financial ruin.
"It's time we know the truth about what's going on with Jackson's finances," Martha Baker, RN, president of SEIU Local 1991, said in a media release. "We owe it to the patients we serve and to the taxpayers who are funding Jackson."
Baker requested the grand jury investigation on Thursday in a hand-delivered letter to Katherine Fernandez-Rundle, the Miami-Dade state attorney.
JHS President/CEO Eneida Roldan, MD, said the union's allegations "are without merit and inaccurate," and that any information about the health system's operations is already open and available in the public domain.
"This is not the time for finger pointing or to cast blame," Roldan said in a media release. "No one person or factor is responsible for Jackson's woes and focusing on blame will get us no closer to a solution. Instead, we must all work together to address Jackson's challenges and to ensure its survival for years to come."
Florida law allows state attorneys to initiate grand jury investigations of public agencies and the public officials who run them. Grand juries can then report findings and recommendations concerning mismanagement, misconduct, or misuse of public funds.
Fernandez Rundle confirmed in a media release that her office had received the request. She said such requests are not uncommon "when concerned citizens feel that parts of their government are functioning poorly."
The Miami-Dade state attorney's spokesperson, Terry Chavez, says it would be "absolutely inaccurate at this point" to call the inquiry a criminal investigation.
"We get these requests all the time. It will be up to the grand jury to decide whether or not they choose to investigate what the union is requesting," she says. Chavez says the investigation request will be acted upon when a new 21-member grand jury begins its six-month term in May.
Baker cited media reports that Jackson executives recently surprised its own governing board by announcing that losses last year were $203 million instead of the $45 million that they initially reported. Jackson executives predicted that losses for the current fiscal year, which ends this September, mushroomed to $229 million from previous estimates of $87 million. Jackson also announced this week that it would begin cost-cutting measures that included laying off 20 union members.
"The only way for us to really find out the true extent of Jackson's mismanagement and current financial problems is for the state attorney's office to follow the money and find out who knew what, and when," Baker said.
Spend enough time in a doctor's office—either as an employee or a patient—and you're going to encounter conflict and tension.
For patients, already anxious about their health, even during well visits, it can be particularly unsettling to hear voices raised or accusations flying. It may be a receptionist dealing with a patient who has just been informed that his copay was raised. It could be an office manager confronting a billing clerk over a documentation error. It could be a physician assistant's personal troubles spilling into the work place.
Whatever the reason, conflict is a cancer in the healing environment. It has to be contained.
For years, Terri Levine, president of North Wales, PA—based Comprehensive Coaching U, has parachuted into stressed out physicians' offices to negotiate an end to hostilities.
"I've never seen a business, a corporation, a physician office, that doesn't have conflict," Levine says. "People are people. There is conflict in our experience. It's part of humanity." By far, she says, the most prevalent form of conflict is among coworkers.
Because of the serious nature of the work in physician offices, even on the best of workdays, stress—the seed corn for conflict—will always be present.
"There is more stress that we find particularly in medical doctor practices than in any others," Levine says. "In a retail store, you mess up, you don't ring up the right order. In a physician's office, you can be dealing with serious life-and-death issues. And the other thing is that most physicians are Type A personalities. Just by the nature of who they are, they can create stress even if they don't open their mouths."
Conflict isn't always about screaming matches at the front desk.
"Sometimes one employee could be angry with another and could be withholding information, being quiet, not giving them everything they need, forgetting to give important data and messages," Levine says. "Anger. Talking behind the other employee's back. Sarcasm. Those are the warning signs that something needs to be handled. Usually it is underneath the surface and you have to look for it because it can become a shouting match."
Paula M. Comm, a practice administrator at PRA Behavioral LLC, serving the northwestern suburbs of Chicago, says the head psychiatrist at the practice has a zero tolerance policy toward workplace conflict. "He hates conflict, and he really practices what he preaches," Comm says. "Especially in a psychiatric practice, you don't want someone coming to the window and feeling the tensions that are going on within the office because it's so apparent."
Comm says she is aggressive in sniffing out workplace tension. And one of the best ways to do it, she says, is to get out of your office and stand in the hall and listen.
"I go up there and just stand. I can get a feel for what is going on immediately. I can tell by the tone, by the attitude. I have an office manager beneath me who isn't attuned," Comm says. "So, I will go in and stand up there and go to her office and say, 'Do you know that it's tense up there?' And she will say 'what do you mean?' "
Levine says one major reason for conflict is personality differences. "We have different beliefs and different philosophies. We have different stories and programs based on our past experience," she says. "Even though I understand my job is to do X, I am still a human being bringing my own personal stuff into the workplace. I'm not going to like everybody else's personality and I may not understand exactly what I need to be doing or there might not be the same communication style between a couple of employees."
Levine says personality profiling plays a prominent role when she coaches employees at physician offices.
"Let's say I find out somebody is a director type. They give quick information; they don't like to converse. If I understand that person's style, I can use behavioral flexibility and talk to them in that way," she says. "If someone is more of a relater, they like to socialize, chit-chat. Then again, we teach how to be more behaviorally flexible in that area."
Levine says many of the employees she coaches are surprised to learn of their personality type, but their coworkers aren't.
"I was with a group last month and one person came out to be a director. The rest of the group was all saying 'Yup!' and the person said 'I didn't think I was like that.' Then as we went through specific examples of how a director behaves, she said 'Yes, that is me.' "
Levine says the way to reduce physician office conflict is not to hire the same types of people, but to make sure each employee understands one another's personality traits.
"We need a combination of personalities in the office. It's better to have all different personalities. If you've got a patient who needs TLC, get the relater our there, not the director," she says. "If you understand how your coworkers function in the world, you can have some behavioral flexibility toward them and some more understanding of who they are."
Levine says there are "three common denominators" in conflict resolution that facilitate that flexibility.
"First, be more understanding of how other people react. Second, increase group cohesion and mutual 'Let's work together to figure out the conflict.' Third, use your improved self-knowledge to understand what happens to you when you feel conflict," she says.
When employees come to her with a complaint about a coworker, Comm says she encourages them to meet face-to-face to constructively to resolve the problem.
"The worst thing is one employee complaining to me about another employee. When I confront that employee, that employee will say 'Why didn't she just tell me in the first place? Why did she have to go to you?' It's kind of like 'I'm telling Mom!' "
"The first response out of me is 'Have you spoken with her directly?' Because that is how you develop healthy relations. You talk to each other directly, because sometimes instant messaging can be misinterpreted," Comm says.
The Ohio House of Representatives is considering a bill that would mandate prison time for people convicted of felony assault against on-duty nurses.
The bill, HB 450, sponsored by Democratic State Reps. Linda S. Bolon of Columbiana, and Denise Driehaus of Cincinnati, would treat a physical assault on a nurse—or her unborn child—the same as an assault on school employees, police, fire, and EMS workers, which under Ohio law is a fourth-degree felony with a mandatory one-year prison sentence.
The proposed law would apply when the victim is an on-duty registered nurse or a licensed practical nurse, who the attacker knows is working as a licensed medical professional.
"I want to do everything in my power to not only protect these hard-working men and women as they do their jobs, but also to aid this vital profession in its efforts to recruit the next generation of nurses," Driehaus said in a media release.
The bill was introduced on Feb. 11 and has yet to be assigned to committee. A fiscal note that would identify any financial impact to the state has not been published.
The Ohio Nurses Association says HB 450 recognizes that violent acts against nurses in the workplace occur more frequently than in any other profession.
"ONA has long advocated for legislation to protect nurses from violence in the workplace, and we are proud to support House Bill 450 as a key part of ONA's overall workplace violence prevention initiative," said Elise Geig, ONA director of Health Policy. Geig says the bill has received bipartisan support from across the state.
BayCare Health System this week opened a new $225 million hospital in suburban Lutz, just north of Tampa. St. Joseph's North is the first full-service hospital built in the Tampa Bay area in more than 30 years.
The 350,000-square-foot, three-story hospital features 108 private beds, 32 of which are for outpatient observation, and 76 of which are for inpatient care. The "all-digital" hospital offers emergency care, surgical services, imaging and diagnostic facilities, ICU, and a family-centered environment.
The full-service Emergency Department at St. Joseph's Hospital-North includes 30 private rooms for adult and pediatric patients. A fast-track area expedites treatment for minor emergencies.
Many of the private suites include large HDTVs, full bathrooms, and accommodations for an overnight guest. Room service provides made-to-order meals.
"Our family-centered care philosophy allows relatives and visitors to be collaborators in patient care," said Paula McGuiness, COO for St. Joseph's Hospital-North. "By incorporating the family, everyone is working together to meet the needs of the patient."
Evidence-based design include an identical floor plan to improve efficiency; workflow designs to ensure that medication, supplies, and meals deliveries keep caregivers close to patients; and noise reduction features, such as carpeted hallways, noise-absorbing tiles and glass sound barriers.
St. Joseph's North is LEED-registered by the U.S. Green Building Council, and the building is designed to achieve green building certification. The building is made of materials that support energy conservation and clean air with low chemical emissions and recycled content.
Austin, TX-based St. David's HealthCare announced today that it will acquire the 58-bed Heart Hospital of Austin from MedCath Corp.
Financial terms of the deal were not disclosed.
"This facility acquisition will complement the already exceptional cardiovascular programs currently operating throughout St. David's HealthCare," said Jon M. Foster, president/CEO of St. David's HealthCare, in a media release. "One of the clinical areas St. David's HealthCare has continued to develop regionally is our cardiovascular service, which is strong thanks to the outstanding care provided by our St. David's HealthCare-affiliated physicians and staff."
The acquisition will be finalized after the regulatory approval process.
St. David's HealthCare operates seven hospitals in the Austin area, and MedCath is a 10-hospital health system based in Charlotte, NC.
The Jan. 12 earthquake that flattened much of Port au Prince, Haiti, and killed at least 230,000 people is providing valuable lessons for disaster preparedness and response on an almost unimaginable scale, says Scripps Health CEO/President Chris Van Gorder.
"There were two reasons why we went down there," says Van Gorder, who recently returned from his second trip to the stricken nation since the earthquake. "The first was humanitarian. The second was the learning. I am passionate about disaster planning and I don't believe the time to learn how to function in a disaster is when the disaster occurs."
Van Gorder concedes that it's doubtful that the United States will experience a natural disaster of similar magnitude because of building codes, infrastructure, engineering, and planning. The Haitian earthquake and the 1989 earthquake that struck the San Francisco Bay area both measured around 7.0 on the Richter Scale. The San Francisco quake claimed 63 lives. Even Hurricane Katrina, with more than 1,800 fatalities, pales in comparison to the death toll in Haiti.
Regardless, Van Gorder says providing care in the most challenging of environments is giving U.S. healthcare professionals valuable experience that can't be replicated by disaster training drills.
"We saw the injuries that would occur in an earthquake—major extremity injuries, major crush injuries, amputations, spinal cord injuries, pressure ulcers caused by people being underground and in the same position for extended periods of time," Van Gorder says.
The Scripps response team and a University of Maryland medical team worked in the remains of the Hospital St. Francois de Sales. It was grim, desperate work under bad conditions.
"Half the hospital collapsed, a four-story building which was their pediatric unit. The estimate was somewhere between 50 and 200 bodies were still entombed in the building," Van Gorder says. "We went into some areas of the hospital that hadn't collapsed, but were adjacent to the building and the smell was atrocious. Our CMO said he almost threw up, and he has been dealing with trauma his entire career."
Even in those hellish conditions, Van Gorder says he was inspired by the extraordinary flexibility and creativity of doctors and nurses.
"They created as sterile an environment as possible without the tools we have here. Our scrub sink was a bucket outside. We saw a rip saw that was being sterilized for amputations. Fortunately we didn't have to use it."
"We were doing our anesthesia on the first trip with ketamine. There was no general anesthesia. There was no intubating the patients during surgery," he says. "A nurse anesthetist gave them a shot and disappeared. I was responsible for monitoring the patients' vitals while the surgeon did surgery and I was a scrub nurse. It wasn't Civil War medicine, but it was more like World War I medicine."
When the Scripps team returned to Haiti with more medical supplies, Van Gorder says they could administer pain medications and general anesthesia.
"Instead of going directly to amputations, we were trying to save limbs," he says. "But we had one woman who died of pneumonia and congestive heart failure. There was no technology there to save her. She died outside under a tent. It was the best we could do under the circumstances."
Van Gorder says the road to recovery for Haiti will be long. Non-governmental organizations that are trying to provide care and other assistance must understand that the Haitian government has essentially ceased to exist.
"The Health Ministry completely collapsed with many of the leaders of healthcare in Haiti killed within the building. The Supreme Court was killed in session. The palace has been destroyed," Van Gorder says.
"The question is what happens from here? It's a poor country that imports everything and exports little if anything. They had a hard time feeding and educating their population before this. Look at the destruction, both in the public and private infrastructure, and you wonder where the money is going to come from to rebuild. I often wonder how long countries and hospitals will have the appetite to continue to work in Haiti. It's not month, we are talking years before they can recover."
The White House hinted that President Obama might post his own health reform bill on the Internet before the bipartisan healthcare summit he is planning for next week, the New York Times reports. Obama has announced the health summit to try breathe life back into the legislation and has promised to put the Democrats' bill online before the session. During a news conference, President Obama said he envisioned posting a merged House-Senate bill that would address his goals of controlling costs and expanding coverage, the Times reports.
