AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve whistleblower allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for off-label uses, federal officials announced yesterday.
The Wilmington, DE-based company finalized the previously announced civil settlement to resolve allegations that—by marketing Seroquel for uses not approved by the Food and Drug Administration—the company caused false payment claims to Medicaid, Medicare, TRICARE, the Department of Veterans Affairs, the Federal Employee Health Benefits Program, and the Bureau of Prisons, the Departments of Justice and Health and Human Services said in a joint media release.
"Today's settlement sends a clear warning to any individual or company seeking to defraud our healthcare system and returns hundreds of millions of dollars of taxpayer money to the Medicare trust fund where they belong," HHS Secretary Kathleen Sebelius said.
AstraZeneca issued a brief statement on its Web site announcing the settlement but denying the allegations. Prosecutors said that AstraZeneca self-reported its conduct in 2006 and cooperated in the investigation.
The federal government will receive $302 million from the civil settlement, and state Medicaid programs will share up to $218 million, depending on the number of states in the settlement. Whistleblower James Wetta could receive more than $45 million from the federal share of the civil recovery.
Federal prosecutors allege that between January 2001 and December 2006 AstraZeneca illegally promoted Seroquel to psychiatrists and other physicians for uses that included aggression, Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness.
Prosecutors said AstraZeneca targeted its illegal marketing towards doctors who do not typically treat schizophrenia or bipolar disorder, such as geriatricians, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.
Prosecutors said AstraZeneca unduly influenced the speakers conducting company-sponsored continuing medical education programs. The drug maker also hired doctors for promotional programs on unapproved uses for Seroquel, to conduct studies on unapproved uses of Seroquel, and to serve as authors of articles that were ghostwritten by medical literature companies. AstraZeneca used the studies to promote unapproved uses of Seroquel.
Prosecutors also contend that AstraZeneca violated the federal Anti-Kickback Statute by paying doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also illegally paid doctors to travel to resorts to "advise" AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other healthcare professionals about unapproved and unaccepted uses of Seroquel.
The settlement includes a five-year corporate integrity agreement.
A new report by a casualty insurance industry think tank says hospitals are cost-shifting billions of dollars in overcharges to automobile insurance companies to offset low reimbursements from Medicare/Medicaid.
A spokeswoman for the American Hospital Association did not deny the allegation. "This report highlights what hospitals have long known: Medicare and Medicaid pay less than the cost of caring for patients," said Caroline Steinberg, AHA’s vice president for trends analysis for policy. "When the government fails to pay its share of healthcare costs, it threatens the financial viability of hospitals, and places upward pressure on the rates paid by private insurers."
The Insurance Research Council report said that in 2007 auto insurance companies paid more than $1.2 billion in excess hospital charges for bodily injury liability claims in 38 tort and add-on states. The full impact of hospital cost shifting, including that in other states, is likely much greater, and will likely prompt auto insurers to more closely scrutinize and negotiate hospital bills, the report said.
"The conventional wisdom is that hospitals aggressively seek to shift costs from public insurance programs to private payers such as auto insurance companies," said Elizabeth Sprinkel, senior vice president of the IRC, in a media release. "With this study, we now have information on the magnitude of cost shifting and a better understanding of the need for supportive state laws and effective tools that will enable auto insurers to pay hospitals appropriately and help control auto injury claim costs."
Steinberg suggested that cost shifting will be an issue as long as hospitals lose money on Medicare/Medicaid, which pay for more than 50% of the care provided by hospitals. In 2008, she said, Medicare/Medicaid payments averaged 90 cents for every dollar spent by hospitals, even as hospitals provided more than $36 billion in uncompensated care. More than half (53%) of hospitals received Medicare payments less than cost, and 56% of hospitals received Medicaid payments less than cost, Steinberg said.
The IRC study, Hospital Cost Shifting and Auto Injury Insurance Claims, studied more than 42,000 auto injury claims. Twenty-two insurers representing 58% of the private auto insurance market participated. The study collected detailed data on injury, medical treatment, claimed losses and total payments, claim handling techniques, and attorney involvement.
IRC found that key predictors of average hospital charges are the percentage of a state's population without health insurance, and the percentage of the population covered by Medicaid.
Sprinkel said the IRC has yet to determine the impact of healthcare reform. "Healthcare legislation enacted by Congress last month underscores the complexity of this relationship," she said. "It will take months, if not years, to understand the full impact of the reforms on hospital cost shifting and the auto insurance system."
Toe Myint, MD, was sentenced Monday in Detroit to six years in prison for his part in a Medicare fraud scheme at sham infusion clinics. An accomplice who recruited patients into the scam will serve more than three years behind bars, federal authorities said.
Myint, of Bloomfield Hills, MI, was also ordered to pay more than $3.1 million in restitution, jointly with co-defendants, and to serve two years of supervised release following his prison term. Terrence Hicks, of Jackson, MI, the patient recruiter, was ordered to pay more than $4.9 million in restitution, jointly with co-defendants, and to serve three years of supervised release following his prison term.
Myint, 56, was convicted by a Detroit jury on Jan. 22, of one count of conspiracy to commit healthcare fraud, following a week-long trial. In the last three months, three Michigan doctors have been convicted of separate healthcare fraud offenses as part of the Medicare Fraud Strike Force operations in Detroit. Hicks, 43, pleaded guilty to one count of conspiracy to commit health care fraud on Dec. 18.
Between October 2006 and March 2007, Myint, Hicks and their co-conspirators submitted more than $4.2 million in false claims to Medicare for services supposedly provided by Myint at Sacred Hope Center Inc., a purported infusion clinic. Medicare paid more than $3.1 million of those claims. Hicks also worked at a second, related infusion clinic, called Xpress Center, Inc., which billed an additional $2.3 million in false and fraudulent claims to Medicare.
So far, 11 defendants have pleaded guilty or have been convicted at trial for their roles in the two fraudulent clinics. Daisy Martinez, an owner of Sacred Hope and Xpress Center, was sentenced in March to eight years in prison.
The pediatric residency program at Sanford Children's Hospital has been accredited by the Accreditation Council for Graduate Medical Education, and will begin admitting residents next year, the Sioux Falls, SD-based health system announced this week.
The residency program is led by Joseph Zenal, Jr., MD, a professor at the Department of Pediatrics for the Sanford School of Medicine of The University of South Dakota. He is also executive director of Medical Education at Sanford Health. The program will hold six residents each year in a three-year training curriculum. Sanford Children's will admit its first residency class in the summer of 2011.
"Sanford Children's Hospital will be the center of training for our residents; however, the program will take advantage of the distinctive characteristics of healthcare in South Dakota, including rural pediatrics and the unique aspects of caring for Native American children," Zenel said.
The program will tap into opportunities at existing and developing Sanford Children's World Clinics in the United States, and international clinics. It will also offer students opportunities with Sanford Research and Sanford Children's Health Research Center. Pediatric residents will work with medical students from the Sanford School of Medicine of The University of South Dakota.
"The immediate goal of the residency program is to enhance the care of children in the Upper Midwest by training specialists in children's health who will populate our communities, both large and small," said H. Eugene Hoyme, MD, chair of the Department of Pediatrics at Sanford School of Medicine of The University of South Dakota. "By keeping local doctors in the area, we are taking pediatric care in this region to the next level."
Sanford Children's Hospital has 76 general pediatric beds, 58 neonatal ICU beds, and 12 pediatric ICU beds. The hospital has 200 pediatric and family physicians, and 350 pediatric-trained staff.
A proposal to compile, compare, and make available to the public the cost of healthcare services at more than 300 California hospitals cleared a major hurdle on Monday when the Department of Justice said it would not inhibit competition.
DOJ said the pricing exchange proposal from the Hospital Value Initiative might actually reduce healthcare costs by improving competition among hundreds of hospitals in California and facilitating more informed purchasing decisions by group purchasers of healthcare services.
"The Hospital Value Initiative will likely provide greater information about the relative costs and utilization rates of hospitals in California and lead payers and employers to make more informed decisions when purchasing hospital services," wrote Christine Varney, Assistant Attorney General in charge of the Department of Justice's Antitrust Division Varney, in a letter to HVI attorneys.
HVI wants to collect, analyze, and distribute comparative data on reimbursements, and the resources used by California hospitals to provide inpatient and outpatient services. HVI is a coalition of three organizations—the Pacific Business Group on Health, the California Public Employees' Retirement System, and the California Health Care Coalition—that represent group purchasers of healthcare services for more than 7 million people.
David Hopkins, director of quality measurement at Pacific Business Group on Health, said HVI was "gratified" by DOJ's decision. "The context for this is transparency and producing information that helps consumers and those who are paying for care know what they are paying for and what they are paying for it," Hopkins said.
DOJ said the proposal isn't anticompetitive because the HVI exchange would involve data that is at least 10 months old, and the program would not disclose disaggregated data or any hospitals' actual service fees. At the same time, DOJ said the data exchange program could benefit consumers by increasing the transparency of the costs and efficiencies of hundreds of California hospitals.
However, Jan Emerson, vice president of External Affairs for the California Hospital Association, said the DOJ's announcement "does not resolve the anti-competitive concerns California hospitals have about this initiative." She noted that DOJ reserves the right to challenge the proposal in the future if it proves to be anticompetitive.
Emerson said California hospitals object to the HVI proposal because it focuses too much on price and not enough on quality. "The initiative's methodology isn't meaningful because every hospital's cost structure is different," she said. "Hospital costs vary based on the amount of uninsured and underfunded Medicare/Medi-Cal patients, specialty services such as trauma care or burn units, unfunded governmental mandates and the need to regularly upgrade their physical plants to meet costly seismic standards and technological requirements."
Hopkins said the HVI members haven't set a date for when they'll launch the project. "We have cleared the antitrust piece and now the question is: 'Are we ready to collect the data and release the results?' We haven't discussed that with our partners yet," he said.
Northwest Community Hospital in Arlington Heights, IL, opens its $250 million, patient-friendly South Pavilion on May 1, the Chicago-area hospital announced.
The nine-story, state-of-the-art addition includes:
200 private rooms designed to reduce the spread of airborne infections, patient falls, and medical errors.
Multiple nursing stations on each floor to reduce staff fatigue and improve care delivery.
Green design with rooftop gardens, soothing colors and focus on quiet surroundings all promote healing.
Cuisine on Call, a program that allows patients to order freshly prepared meals at the specific time they are ready to eat.
Advanced monitoring and treatment technologies are built into each patient room, along with Wi-Fi access. Natural light streams in through floor-to-ceiling windows. Handrails that run between patient beds and private bathrooms make navigation easier and safer. And there’s a comfortable sofa for a family member to stay overnight. Patients and families can even take advantage of balconies on each floor for fresh air. The South Pavilion is on track to be Leadership in Energy and Environmental Design certified.
The addition also includes a Critical Care Unit, Labor and Delivery area, and Special Care Nursery.
President Obama's executive memorandum last week giving hospital patients the right to grant visitation to same-sex partners was as decent as it was overdue.
The president said he was moved to issue the memorandum after hearing about the plight of a woman denied access to her partner of 18 years who was dying in Jackson Memorial Hospital in Miami hospital after suffering from a brain aneurism.
However, in this highly partisan atmosphere, where every White House action prompts a dog fight, the reporter in me figured that somebody, somewhere in healthcare was going to be upset. After all, hundreds of hospitals in this nation are affiliated or operated by religious denominations, some of which explicitly denounce homosexuality as a sin.
It seemed like an easy story. Get a few quotes "pro" and "con," a little background, a little brouhaha, and hit the "send" button. The "pro" quotes were pretty easy to come by, but I was surprised when I tried to find someone in healthcare to speak out against the memo. Instead of controversy, I got acceptance.
My first instinct was to check with the Catholic Health Association of the United States, only because the Roman Catholic Church has been quite emphatic in its rejection of homosexuality. Would Obama's memorandum prompt a crisis of faith for some of the nation's largest group of not-for-profit health systems?
No.
"The Catholic Health Association has long championed the rights of all patients to designate who they want to speak for them in healthcare decisions when they are not able to speak for themselves," Sister Carol Keehan, president/CEO, said in a statement on the CHA Web site. "Having that person clearly designated is not only a basic human right, it also greatly facilitates care."
I checked with Baptist Health South Florida. No controversy there "From our perspective, it's not an issue because we have a very flexible and open family visitor policy that we established years ago," said Health system spokeswoman Christine Kotler. Kotler says she hasn't heard of any objections from Baptist employees. "We asked that question of our social work services, our nursing administrators. We did circulate that question and resoundingly everyone came back and said this has never been an issue," she said.
Jackson Health, the inspiration for Obama's memorandum, actually pre-empted the president's announcement by a few days with word that it had worked with with a coalition of lesbian, gay, bisexual, and transgender groups to create a more-inclusive visitation policy.
Let's be clear: I didn't conduct an exhaustive search on the issue—a few passes through Google and some media outlets—and I'm not saying that everyone within healthcare supports the President's memorandum. I'm saying I couldn't find any healthcare organizations that oppose it.
None of this is surprising. Visitation rights are not abstract talking points for healthcare professionals. Physicians and clinicians see first hand, every day, how important it is for same-sex couples to enjoy the same rights and access to loved ones as everyone else. I suspect that many healthcare professionals have also witnessed the heartbreak—the fundamental unfairness of it—when that access is denied.
Sister Keehan said it best: "All persons of goodwill can understand and agree that when a person is sick, they deserve to decide who they want to visit them."
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There were 12 mass layoffs impacting 50 or more jobs at the nation's nongovernment hospitals in March, resulting in 798 initial claims for unemployment insurance, the Bureau of Labor Statistics announced today.
March's mass layoffs, combined with 11 mass layoffs in February and 13 in January, are just one mass layoff event off the record pace set in the first quarter of 2009, a year that ended with 152 mass layoffs affecting more than 13,000 hospital jobs. In the first quarter of 2010, hospital layoffs resulted in 2,516 initial claims for unemployment, compared with 3,003 such claims in the first quarter of 2009, BLS data show.
In the overall healthcare and social assistance category, there were 33 mass layoffs in March, resulting in 2,066 initial claims for unemployment insurance, BLS data show.
Despite the layoffs, the healthcare sector remains one of the few job growth areas of the economy. Hospitals created 33,400 new jobs in 2009, while the overall healthcare sector has created 588,000 jobs since the recession began in December 2007. In that same period, the number of jobless people in the nation has risen from about 7.7 million to 15.3 million, BLS data show.
In March, in the overall economy employers reported 1,628 mass layoffs that resulted in job losses for 150,864 workers, seasonally adjusted, as measured by new filings for unemployment insurance benefits for the month. The number of mass layoff events across all industries in March increased by 58 from the 1,570 reported in February, and the number of initial unemployment claims fell by 4,854. Both events and initial claims have decreased in five of the last seven months, BLS said.
After 10 years on the job, IASIS Healthcare LLC CEO David R. White will retire by the end of this year but will continue to serve as chairman of the Franklin, TN-based hospital chain's board of directors, the company announced this week.
IASIS CFO W. Carl Whitmer has been named president and will become CEO when White retires. Whitmer, CFO since 2001, also will join the IASIS board, as will long-time IASIS COO Sandra McRee, who becomes vice chair.
"While there is likely never the perfect time to retire, this is certainly the right time to make this transition," White said in a media release. "IASIS is in a very strong position, has a well-planned growth strategy and has an excellent leader in Carl Whitmer, who is poised and ready to take IASIS to the next level."
"Our industry is undergoing tremendous change. IASIS is well situated to take advantage of its strengths, build upon its success and respond to change. Because of our advance planning, we are confident this will be a smooth transition," White said.
Since White took over at IASIS in 2000, annual revenues have grown from $815 million to more than $2.4 billion, and the hospital chain has spent more than $100 million to improve healthcare information technology, the company said.
A national search is underway to fill McRee's COO position, but no specific timeframe has been set. John Doyle, IASIS' vice president and CAO, replaces Whitmer as CFO.
IASIS owns or leases 15 acute care hospitals and one behavioral health hospital in six states, with a total of 2,848 beds. IASIS also owns and operates a Medicaid/Medicare managed health plan in Phoenix, AZ, with more than 198,000 members.
Barnes-Jewish Hospital, St. Louis Children's Hospital, and Washington University School of Medicine have created a joint Fetal Care Center for high-risk mothers and births.
The Fetal Care Center will coordinate access to the maternity center at Barnes-Jewish Hospital, the nearby neonatal ICU at St. Louis Children's Hospital, and medical and surgical services from Washington University for the nearly 10,000 babies born each year in Missouri and the surrounding eight states who have serious medical conditions requiring specialized care.
It is also the only center in the Midwest offering advanced fetal diagnosis, fetal surgical interventions, and newborn medicine on one medical campus, the three provider institutions said in a joint announcement.
"We don't think a mother-to-be should wait for answers," said Anthony Odibo, MD, co-director of the Fetal Care Center and associate professor of obstetrics and gynecology at Washington University. "That's why we've designed our program to provide results, develop a plan -- even begin treatment, if necessary -- right on the spot."
Barnes-Jewish Hospital and St. Louis Children's Hospital are adjacent, which will allow mother and baby to be on the same medical campus at the Fetal Care Center. "Delivering at a hospital that doesn't have the capacity to address some of these really important things then mandates the baby be transported from one facility to another," said Brad Warner, MD, surgical directory at the center. "That can be critical time and can sometimes make the difference between life and death."
The center has stress-reducing amenities, such as convenient appointment scheduling, personal nurse advocates, all tests done at one time and place, and an end-of-day physician conference to summarize test results and make team recommendations.
The center will specialize in surgical treatment, both in-utero and after delivery, to correct prenatal diagnoses including congenital heart defects, twin-twin transfusion syndrome, gastroschisis, omphalocele, and congenital diaphragmatic hernia.
