Mar
11
New bone: An x-ray image of a patient who had a leg lengthened using the new
surgical method. This image was taken after six months, showing a healed bone.
Credit: Ulf Knothe
A simple method uses stem cells from bone tissue to repair serious injuries quickly and cheaply.
MIT Technology Review, March 10, 2010, by Brittany Sauser – A new surgical procedure can repair severe bone injuries and defects more quickly and simply than current methods, which include bone-grafting operations and lengthening procedures that involve inserting pins through the skin to pull bones together.
The new technique makes use of a thin tissue called the periosteum, which lines the outer surface of all bones and contains stem cells that develop into bone to repair damage. To repair major bone breaks, or repair serious defects, the researchers use the periosteum as a sleeve placed around a missing section of bone to encourage bone regrowth. For cases where there is not enough periosteum, the researchers have developed an artificial membrane as a substitute.
Melissa Knothe Tate, a professor of biomedical engineering at Case Western Reserve University in Cleveland, and her husband, Ulf Knothe, an orthopedic surgeon at the Cleveland Clinic, have successfully tested their method on a wheelchair-bound patient who needed surgery to lengthen one of her legs. They’ve also successfully tested it on sheep. The researchers presented their work yesterday at the Orthopedic Research Society meeting in New Orleans.
In the new procedure, carried out on the wheelchair patient, the researchers made a small vertical incision in the periosteum near to where a large piece of bone was missing after the leg had been lengthened. They then peeled the periosteum back, so that it remained attached to the blood vessels on the outside, and cut away a piece of bone beneath, which was then used to plug the large gap in the leg bone. The periosteum was sutured closed, forming a sleeve around the section from which the bone was removed. The gap was repaired by the transplanted segment of bone while cells from the sutured periosteum infiltrated the space below it and turned into new bone. The patient saw new bone growth one month after surgery. Knothe Tate says that such a defect would normally not heal without more serious surgery.
One of the most common methods for treating a severe bone injury is to take bone from a non-weight-bearing area like the hip and graft it onto the injured site, but that can leave the site the bone was taken from at risk of a fracture. Jennifer Elisseeff, a biomedical engineer at Johns Hopkins University, says very little can be done to fix large gaps in bone, but adds that the new technique “will have a significant effect for healing fractures.”
Norman Marcus, an orthopedic surgeon at the Virginia Cartilage Institute, in Springfield, VA, says artificial treatments fall into two categories: structural and growth-related. Structural products, typically called bone fillers, can be made of items like coral and calcium phosphate. Growth-related products, which are usually in the form of powders and gels, are used to stimulate bone growth. While the growth promoters are more effective, they are expensive, says Marcus.
The researchers have also created an artificial periosteum sleeve, which they tested in sheep, for bone injuries where there is not enough tissue available. The artificial membrane was seeded with collagen; a mixture of collagen and periosteal cells taken from a particular sheep; or pieces of periosteum from the patient’s surrounding bone. The researchers wrapped the sleeve around the injured area and sewed it on like a patch. They found that the sheep given the periosteum alone experienced the fastest repair, with new bone growth two to three weeks after surgery.
The work “combines tissue engineering approaches with surgical intervention and leverages the natural ability for repair,” says Elisseeff.
One problem is that stem cells can differentiate into different things like tendons, cartilage, or bone, says Marcus. The researchers showed that the stem cells in the periosteum were coaxed into becoming bone by mechanical stress. For instance, in the sheep experiments, the mechanical cues happen naturally when the sheep shift their weight.
“There are lots of experimental techniques but few clinical methods, and if this has been successful in patients, that is where the real breakthrough will be,” says Farshid Guilak, a professor of orthopedic surgery and director of the Orthopaedic Bioengineering Laboratory at Duke University Medical Center.
“This is very important progress,” adds Yunzhi Yang, an assistant professor at Houston Biomaterials Research Center at the University of Texas Health Science Center in Houston.
Knothe Tate says the plan is to license the technology to companies by the end of the year, and says there are a couple of “major players” interested. “We want to provide a cheap alternative that can be widely used in the field,” she says
Filed Under News | Leave a Comment
Mar
11
The-Scientist.com, March 10, 2010, by Bob Grant – Two hundred kilometers north of Hobart, Tasmania, on a late September afternoon in 2001, two men broke into the rural home of 71-year-old Fay Olson. The intruders—armed with sticks and wearing black hoods—ransacked Olson’s home, forced her to open a safe, stuffed AU$550 into a pillow sack, and fled into the bush surrounding the house. They left Olson tied up with a belt cinched around her ankles. The pair made off with their loot scot-free, but one of the perpetrators inadvertently left something behind that would spell his undoing 8 years later: a leech, swollen with his DNA-filled blood.
Tasmanian investigators found little in the way of evidence that could tie the criminals to the crime, but one of the officers on the scene noticed a bloated leech wriggling next to the pilfered safe. He collected the parasite—likely Philaemon grandis, endemic to Tasmania—as the lone piece of evidence that might help catch the men.
“[The leech] had obviously just fed,” says Michael Johnston, the lead investigator on the case. “It was fully engorged.” Johnston and his fellow officers noted that neither they nor Olson had been bitten by the leech, so reasoned that it had to have dropped off one of the criminals.
They kept the leech, killed it, and smeared some of its final blood meal onto a special card treated with DNA preservatives—standard police procedure. The blood sample was sent to Forensic Science Service Tasmania (FSST), the lab that handles DNA profiling and forensic chemistry for the state’s police. Pam Scott, who was a case worker then but is now the manager of forensic biology at FSST, remembers when the leech sample came into the lab. “It was certainly something out of the blue and a very good piece of lateral thinking by the investigators at the scene,” she says. “We did get a [DNA] profile from it.”
That forensic investigators got a viable sample of human blood from the leech was not that surprising, according to Mark Siddall, director of the American Museum of Natural History’s leech lab in New York City. Leeches typically consume about 6 times their own body weight in blood, and the quick-thinking Tasmanian police preserved the blood soon after finding the leech. “My guess is that as long as the leech isn’t allowed to rot, then it would probably behave almost as any other piece of forensic material,” notes Siddall, who wasn’t involved with the case. Siddall adds that using human-specific primers to amplify the DNA from the leech’s blood meal would prevent the amplification of leech DNA, which may interfere with analysis.
Sadly, the DNA isolated from the human blood in the leech didn’t match any other genetic profiles on the Tasmanian DNA Database, so the case went cold.
Then last year, Tasmanian police caught a break in the case. Peter Cannon, a 54-year-old Tasmanian man, was picked up on drug charges and submitted a blood sample from which police pulled a DNA profile. When investigators entered Cannon’s DNA data into the database, a match came back—the blood inside the leech left in Olson’s looted home bore the same profile as Cannon’s. Confronted with this, Cannon pled guilty to aggravated armed robbery and is serving out his 2-year sentence in a Tasmanian prison.
“This would appear to be the first and only time anywhere in the world that a leech served as a source of [incriminating] DNA.” says Johnston, now acting commissioner of Tasmania’s northern district.
The case of Cannon and the Tasmanian leech that led to his conviction demonstrates that the potential sources of incriminating DNA evidence may be limitless. “Maybe there’re other sources that aren’t leaping out at us currently,” says Scott. And could the leech that caught Cannon boost the reputation of its brethren still in the swamps?
“If anything, it does something for the reputation of Tasmanian forensics, that they had the presence of mind to do this,” Siddall says.
The Scientist: Slime and punishment – The Scientist – Magazine of the Life Sciences http://www.the-scientist.com/article/display/57168/#ixzz0holEfu0M
Filed Under News | Leave a Comment
Mar
11
In a pilot project, technology reduced doctor’s visits for patients with chronic illness, but will this work on a broader scale?
MIT Technology Review, March 10, 2010, by Emily Singer – Connecting patients and their physicians through the internet might help cut down on office visits, according to results of a pilot project announced today. More than 250 patients with chronic diseases, namely diabetes, heart failure, and hypertension, participated in the study, tracking their health at home with heart rate monitors, glucometers, scales, pedometers or blood pressure monitors. Data from those devices was then uploaded to the patient’s HealthVault record, a personal medical record system developed by Microsoft. That data was in turn connected to the electronic medical records used by the Cleveland Clinic, allowing doctors to monitor their patients remotely.
According to a the following press release from the Cleveland Clinic:
“The project found a significant change in the average number of days between physician office visits for patients. Diabetic and hypertensive patients were able to make doctor’s office visits less often, increasing the number of days between appointments by 71 percent and 26 percent respectively, indicating that patients had better control of their conditions. Heart failure patients, however, visited their doctors more often, decreasing the number of days between visits by 27 percent, indicating that patients were advised to see their healthcare provider in a more timely manner.
… “Making it easier for patients to more actively engage in their ongoing health and wellness is a necessary step in trying to manage the increasing onset of chronic disease worldwide and the costs associated with this alarming trend,” said Peter Neupert, corporate vice president, Microsoft Health Solutions Group. “The results of this pilot are promising and demonstrate how cost-effective and flexible technology solutions can support patients in better monitoring their chronic conditions from where they live and work.”
Any option for reducing health care costs is, at the moment, a hot topic. But how successful will this type of program be on a broader scale? My doctor belongs to a tech-savvy medical practice. (One of the first, in fact, to adopt electronic medical records.) And despite a handy online system that allows me to check my test results and contact my physicians, I can’t even get him to answer emails. So I have a hard time imagining him poring over reams of heart rate and blood pressure data.
The question is not just whether the system reduced office visits, but whether it helped cut down physician’s time expenditure per patient, either by helping patients stick to their treatment plans, or by transferring some of the evaluation process to less-skilled personnel or even a computer program. It’s unclear from the information released whether patients better monitored their own health, which perhaps made them more compliant with medication regimens, reducing the need to see the doctor. Or whether a nurse or other health care practitioner was able to monitor the medical record, only alerting the doctor of concerning data.
Filed Under News | Leave a Comment
Mar
11
US President Barack Obama’s 2009 executive order to allow the federal funding of research using new human embryonic stem cell (hESC) lines may become law
The-Scientist.com, March 10, 2010, by Jef Akst – Yesterday (March 9), on the one-year anniversary of Obama’s announcement, members of Congress Diana DeGette of Colorado and Mike Castle of Delaware reintroduced the Stem Cell Research Advancement Act to “ensure a lasting ethical framework” for such research. DeGette and Castle were the lead sponsors of the bill when it was introduced during the tenure of former President George W. Bush, who vetoed it twice.
The legislation would codify Obama’s executive order, which overturned the limitations implemented by Bush, and made it possible for scientists to use federal funds to study hESCs derived after August 9, 2001. So far, the National Institutes of Health (NIH) have approved a total of 43 lines, more than double the lines available for distribution during the Bush administration.
The new bill builds on the NIH guidelines introduced last summer for approving hESC lines for federal fudning, and requires that the NIH review and update the guidelines at least every three years, as well as submit a biennial report to Congress on the research.
“Congress must still enact legislation so that both scientists and individuals who stand to benefit from the promise of this research will have some stability backing their quest for life-changing cures,” DeGette said in a statement.…….read the statement here…………. http://www.castle.house.gov/News/DocumentSingle.aspx?DocumentID=175218
Read more: Stem cell regs to become law? – The Scientist – Magazine of the Life Sciences http://www.the-scientist.com/blog/display/57211/#ixzz0hopIx29O
Filed Under News | Leave a Comment
Mar
10
Long-Term Care Hospitals Face Little Scrutiny
Trail of Disquieting Reports From Hospitals of Select Medical (February 10, 2010)
Steve Hebert for The New York Times
GOING PUBLIC Sheryl Laing, who worked for Select
Medical, said she grew frustrated with its management.
Select Medical’s executives, Rocco Ortenzio, left,
and Robert Ortenzio at the initial public offering in
September. New York Stock Exchange
LONG-TERM CARE Tina Bell-Jackman was chronically
ill with diabetes.
No one at the hospital noticed that Tina Bell-Jackman was dying. In a scathing report after Ms. Bell-Jackman’s death, Medicare inspectors found that the hospital did not have enough nurses on the night she died and that the volume on her monitor was turned down. “The audible alarms could barely be heard,” inspectors wrote. In addition, although staff members “recognized the need to report the death” because she had been in restraints, “they stated the corporate legal department advised the hospital not to report the death” to Medicare. Select’s lawyers did not think that the company needed to report the death, the company said.
The New York Times, March 9, 2010, by Alex Berenson — On the night of June 26, 2007, Ms. Bell-Jackman turned restlessly in her bed in Room 7 at Select Specialty Hospital of Kansas City, a small medical center that specializes in treating chronically ill patients. Ms. Bell-Jackman, a 46-year-old with diabetes, had been hospitalized at Select for five weeks, was increasingly agitated and could not speak because of a surgical hole in her throat. Her physicians had ordered the hospital to keep a sitter with her.
But at 8 p.m., the sitter left, according to a state court lawsuit and a Medicare inspection report. Left alone, Ms. Bell-Jackman tried to get up. Around 9:30 p.m., staff members tied her down with wrist restraints. Around 12:15 a.m., after the restraints had been removed, a nurse injected her with a sedative to calm her.
In other hospitals, an attending physician might have seen Ms. Bell-Jackman. But the Select hospital of Kansas City has no doctors on its staff or its wards overnight. In emergencies, it must call in physicians from outside.
More than 400 similar facilities, called long-term acute care hospitals, have opened nationally in the last 25 years. Few of them have doctors on staff, and most are owned by for-profit companies. The Kansas City hospital is part of a chain called the Select Medical Corporation, a publicly traded Pennsylvania company that runs 89 long-term hospitals, more than any other company.
Lawsuits, state inspection reports and statistics deep in federal reports paint a troubling picture of the care offered at some Select hospitals, and at long-term care hospitals in general.
In 2007 and 2008, Select’s hospitals were cited at a rate almost four times that of regular hospitals for serious violations of Medicare rules, according to an analysis by The New York Times. Other long-term care hospitals were cited at a rate about twice that of regular hospitals.
Long-term care hospitals also had a higher incidence of bedsores and infections than regular hospitals in 2006, the most recent year for which federal data is available.
Fewer than 10 hospitals dedicated to long-term care existed in the early 1980s, according to Medicare officials. But many such hospitals have sprouted since then, driven by Medicare rules that offer high payments for hospitals that treat patients for an average of 25 days or more. Long-term care hospitals now treat about 200,000 patients a year, including 130,000 Medicare patients — at a projected cost of $4.8 billion to the government this year, up from $400 million in 1993.
Unlike other specialized hospitals, like psychiatric or children’s hospitals, long-term care hospitals do not treat specific types of patients or offer services unavailable in regular hospitals. They are defined solely by the fact that they keep patients longer than other hospitals. They are also smaller than a typical hospital, averaging about 60 beds.
Many patients at hospitals that specialize in long-term care are very sick. While usually in stable condition, they may be on dialysis, need a ventilator or have wounds that will not heal. If patients need surgery or suffer serious medical emergencies, they are usually transferred back to general hospitals.
Nontraditional Hospitals
Despite the rapid expansion of long-term care hospitals and the serious illnesses they treat, Medicare has never closely examined their care. Unlike traditional hospitals, Medicare does not penalize them financially if they fail to submit quality data.
Supporters of long-term hospitals say that even without staff physicians, they provide high-quality care and play an important role by treating patients who are too sick for nursing homes but are not improving at traditional hospitals. Hospital intensive care units help patients survive acute illnesses, heart attacks and trauma, but they are not intended to treat patients for weeks or months.
Of course, traditional hospitals can move those patients to regular medical wards for treatment. But under Medicare payment rules, traditional hospitals often lose money on patients who stay for long periods. So they have a financial incentive to discharge patients to long-term hospitals, which then receive new Medicare payments for admitting the patients. Both hospitals benefit financially.
That dynamic, rather than evidence that long-term hospitals benefit patients, has driven their expansion, said Dr. Jeremy M. Kahn of the University of Pennsylvania, who has received a federal grant to study the hospitals. The industry’s growth is an example of how health care companies can exploit the $450 billion Medicare program, he added.
“The U.S. health care system allows unintentional financial incentives to drive sweeping changes,” Dr. Kahn said.
The questions about long-term care hospitals center on the for-profit side of the industry, led by Select and Kindred Healthcare, another publicly traded company.
For-profit long-term hospitals generally spend less on patients and have higher margins than comparable nonprofits, according to data from the Medicare Payment Advisory Commission, a Congressional research agency.
In 2007, for-profit long-term care hospitals had margins of 6 percent on Medicare patients, while regular hospitals lost an average of 6 percent on Medicare patients, according to the commission.
In a presentation to investors last month, Select Medical reported that it improved its margins by monitoring staffing levels and lowering supply costs.
Medicare inspection reports, however, describe preventable patient injuries and deaths, and they portray Select’s hospitals as understaffed and with high turnover.
In the last three years, inspectors have found 22 violations of care standards at 12 Select hospitals so serious that, if uncorrected, could lead Medicare to ban those hospitals from admitting Medicare patients.
The 22 violations represent an estimated 2 percent of the serious violations Medicare found nationally, even though Select operates less than half a percent of the nation’s hospital beds. Put another way, on a per-bed basis, Select hospitals were cited about four times as often as the average.
Select also appears to manage how long patients stay, to maximize its profits. A hospital is certified as a long-term care hospital and receives high Medicare reimbursements if most patients stay at least 25 days. But Medicare pays the hospital a set amount for each patient, meaning that patients who stay longer than that become less profitable.
Therefore, long-term care hospitals are most profitable if most patients are discharged at or just after their 25th day, with a few discharged earlier. Select adheres closely to this formula, with an average length of stay at its hospitals of about 24 days, according to public filings. At some Select hospitals, the 25th day is called the “magic day,” ex-employees say.
And in 2007, an inspector for Medicare found that a case manager at a Select hospital in Kansas had refused to discharge a patient despite the wishes of his physician and family. The hospital calculated it would lose $3,853.52 if it discharged the patient when the family wanted, the inspector found.
Select strongly defends its care. In a statement, the company said that the Medicare reports represented isolated incidents, that it corrected any problems that inspectors found and that it did not discharge or hold patients for financial reasons.
“In 13 years of operating hospitals, we have a demonstrated record of regulatory compliance and quality patient care,” the company said in a statement. While Select hospitals do not have physicians in-house around the clock, they always have doctors on call, said Carolyn Curnane, a Select spokeswoman. And its patients, like those at other hospitals, are seen by physicians at least once a day.
Select also said that a privately maintained database showed that it was better at weaning patients off ventilators and helping them avoid pneumonia than typical hospitals.
“The picture you draw about Select Medical is inaccurate and misleading,” the company wrote in response to a reporter’s questions about the Medicare findings.
Partly owned by a private equity firm, Select Medical sold shares to the public in September. Its top two executives, a father and son named Rocco and Robert Ortenzio, have made about $200 million from salary, benefits and share sales since founding Select in November 1996. The Ortenzios, who are veterans of the for-profit hospital industry, still own about 10 percent of the company, worth about $200 million.
Hiring a Director
Select, which has 23,000 employees and provided care to 42,000 patients in 2009, has no physicians on its board or in management. In 2007, it hired a physician for a new position, national medical director. The physician, Dr. David Jarvis, does not work at Select’s headquarters in Mechanicsburg, Pa., and has no management responsibilities. He estimated he spent only 10 hours a week working for Select Medical.
“I’m sort of part time,” Dr. Jarvis said. He said that Select Medical “would probably benefit” from having a full-time physician on staff. Select’s corporate medical officer, Mary Burkett, is a registered nurse who is not listed among the company’s top 10 executives on its financial statements.
Select said that it had several corporate-level employees responsible for ensuring safe care and that each hospital had a full-time quality manager. “In addition, a corporate survey nurse makes unannounced hospital visits to look for potential problems,” the company wrote. “Unfortunately, we cannot prevent our staff, as well trained as they are, from making mistakes on rare occasions.”
Select allowed a reporter to tour its hospital in Nashville, where Dr. Jarvis sees patients, though he is not on the hospital’s staff. During a four-hour visit in December, the hospital appeared clean and well run. Patients and their families said they were happy with the care they received.
Dr. Jarvis defends Select and the industry, saying that long-term care hospitals play an important role by caring for patients who are not improving at traditional hospitals. Nurses and aides at traditional hospitals may grow frustrated with such patients, but Select’s nurses and aides are used to them, he said. And after aggressive intensive care treatment, long-term patients need gentler care that will enable them to recover on their own.
“These people do better when we don’t overdo it,” he said.
Patients who need scans or more intense care can be transferred back to traditional hospitals. But some patients cannot be saved even with the best care, he said. Indeed, about 12 percent of Select’s patients die while hospitalized. “We see such sick people,” Dr. Jarvis said.
Among the more peculiar aspects of long-term care hospitals is that nearly half of them, and almost all of Select’s, are actually “hospitals within hospitals.” They do not have their own buildings and instead occupy a floor or two of an existing hospital. They contract most services from the host hospital, so they can be opened quickly and cheaply.
Yet under Medicare rules, because they have different owners, the two hospitals are considered separate for payment purposes. This means there can be a second reimbursement when a patient is simply transferred between floors.
A Case Is Settled
Select’s Kansas City hospital sits on the fourth floor of the Overland Park Regional Medical Center, in a Kansas City suburb. On Oct. 7, 2004, Bill Dean Borum lay in bed there, recuperating from a forklift accident that had led doctors to amputate part of his left leg.
Mr. Borum, 69, also suffered from diabetes and a perforated bowel. Nonetheless, after a month at Select, he had been weaned from a ventilator, according to Wanda Stagg, his sister. “I went to see him almost every single day, and he was starting to talk better and do better,” Ms. Stagg said.
Then, around 5 a.m. on Oct. 8, a nurse at Select called Ms. Stagg, telling her that her brother had died of a heart attack. Sheryl Laing, who was the hospital’s director of quality, later told Ms. Stagg that a nurse had turned off Mr. Borum’s heart monitor because the nurse was tired of listening to the monitor beep.
In October 2005, Ms. Stagg and Mr. Borum’s daughter sued. The case, in state court in Kansas, was dropped in 2006, after Select paid Mr. Borum’s family $195,000, according to court records. The nurse involved was fired, Ms. Laing said.
Select did not admit liability in the settlement. In answer to questions about the case, Select said that its “monitoring policy in place at that time met the prevailing standard of care” and that the death resulted from “human error and a failure to comply” with the company’s policy.
Because of Mr. Borum’s death and a second event she described, Ms. Laing pressed Select’s corporate officials to let the hospital hire a clerk to watch the heart monitors, she said. Patients’ rooms lay on a long corridor, with the nurses’ station at one end. “You could be fairly close and not be able to hear the monitors,” Ms. Laing said.
But Select Medical refused, saying that nurses should check the monitors, also called telemetry machines, between their other duties, Ms. Laing said. Jason Hedrick, an occupational therapist who was the hospital’s chief executive at the time, offered a similar account in a deposition in September 2008. Asked why Select Medical had refused to hire a clerk, Mr. Hedrick said, “I would say that it’s, it’s a financial reason.”
Select said in a statement that it disputed the accounts of Ms. Laing and Mr. Hedrick and that they never asked the company for a clerk.
Ms. Laing joined the Select Kansas City hospital as a nurse in 2002, after years working as a counselor at a center for veterans. She was promoted to director of quality in the summer of 2004. In December 2006, she was promoted again, to director of clinical services. Despite the promotions, she grew frustrated with Select Medical’s corporate management. She said she believed that Select’s failure to spend adequately put patients at risk.
Alarms Sound
Select had not hired a person to watch the telemetry machine on May 25, 2007, when Tina Bell-Jackman was admitted from Overland Park Regional, the host hospital for Select. Ms. Bell-Jackman, a smoker who suffered from poorly controlled diabetes, needed a ventilator to breathe. Slowly, she regained her strength.
By late June, she could breathe unaided and walk a few steps, though she was unable to speak because surgeons had cut a hole in her throat for a tracheostomy tube. “She was getting ready to leave the hospital,” Ms. Laing said. “She was never going to be a really healthy person, but it seemed like she was on the way to being her best.”
After the sedative injection at 12:15 a.m. on June 27, Ms. Bell-Jackman seemed to relax. But at 12:42 a.m., the leads connecting her heart monitor to her chest came loose. The machine sounded an alarm at a nursing station. No one responded.
As her alarm rang and the minutes ticked by, Ms. Bell-Jackman went unaided. Finally, during a bed check at 2 a.m., Samuel A. Danso, the nurse responsible for treating Ms. Bell-Jackman overnight, noticed she was unconscious. Efforts to revive her failed. She was pronounced dead the next day, without having regained consciousness.
Two days after Ms. Bell-Jackman’s death, the hospital fired Mr. Danso. He did not return calls for comment.
In a scathing report after Ms. Bell-Jackman’s death, Medicare inspectors found that the hospital did not have enough nurses on the night she died and that the volume on her monitor was turned down. “The audible alarms could barely be heard,” inspectors wrote. In addition, although staff members “recognized the need to report the death” because she had been in restraints, “they stated the corporate legal department advised the hospital not to report the death” to Medicare. Select’s lawyers did not think that the company needed to report the death, the company said.
On July 18, a week after the Medicare inspection, Select Specialty hired a full-time technician to watch the heart monitors. In September 2007, Select fired Ms. Laing. The company did not give a reason for her firing, she said. But she says she believes it had grown tired of her complaints about its practices. Select declined to comment about Ms. Laing’s dismissal.
In January 2008, Ms. Bell-Jackman’s family filed suit against the hospital in Johnson County Court in Kansas, later adding Select Medical, the parent company, as a defendant. In June 2009, the hospital, which is insured separately from the parent company, settled the claim against it by paying Ms. Bell-Jackman’s family $800,000, while denying wrongdoing. On Jan. 20, after being asked by The New York Times about the case, Select Medical agreed to a settlement with Ms. Bell-Jackman’s family. Terms were not disclosed.
Through their lawyer, Dr. Samuel K. Cullan, the family declined to comment.
In a statement, the company said: “Ms. Bell-Jackman’s death was a tragedy for which we are deeply sorry. Select conducted an appropriate clinical review following Ms. Bell-Jackman’s death and terminated a clinician involved in her care.” As for Ms. Laing, she now works at a veterans’ hospital in Leavenworth, Kan., where she says she is much happier. She added that she regretted not reporting her concerns to state inspectors or Medicare officials.
“I should have been more verbal with outside entities, but sometimes you get in a situation where that’s not your first thought,” she said. “You just try to do the best you can with what you have.”
“Just talking about this makes me mad, because it shouldn’t have happened this way,” she said. “She shouldn’t have died in our hospital.”
Many other Select hospitals have problems, according to Medicare inspectors. But questions about patient safety at long-term care hospitals extend well beyond Select’s hospitals.
In 2006, nine out of 1,000 Medicare patients developed serious infections in long-term care hospitals, according to a March 2009 report from the Medicare Payment Advisory Commission. In contrast, fewer than three out of 1,000 patients over 65 — a group made up almost exclusively of Medicare patients — developed infections at traditional hospitals that year, according to the federal Agency for Healthcare Research and Quality.
But Medicare has few levers to discipline long-term care hospitals, or any hospitals. Hospitals must submit plans to correct the problems that inspectors find, but the program cannot impose fines or reduce payments.
In theory, Medicare can force hospitals out of the program, but because that penalty is like forcing a hospital to close, the agency almost never uses it.
“It is typically only when the deficiencies are chronic or serious, such as when they directly affect patient care, that Medicare will take the unusual step of threatening decertification,” said Robert L. Roth, who was a senior lawyer for Medicare.
In 2009, when Medicare tried to force out the Select hospital in St. Louis, the company sued. A federal judge found the penalty unwarranted and granted an injunction forbidding Medicare to follow through. The violations in the St. Louis case did not directly harm patients, the judge found. The two sides eventually settled, with the hospital agreeing to hire outside experts.
For years, Medicare reimbursement rules have encouraged the growth of long-term care hospitals, said Dr. Christopher E. Cox, an associate professor of critical care medicine at Duke University.
Under Medicare, hospitals receive a payment for a patient based on the patient’s diagnosis, not the cost of care. Patients who recover quickly are profitable, but those who languish are not. “A lot of the time, hospitals would be losing money on these kinds of patients,” Dr. Cox said.
But if a regular hospital transfers a patient to a long-term care hospital, the long-term hospital gets a payment from Medicare that averages about $40,000. Meanwhile, the regular hospital frees up a bed for a new patient — and new reimbursement.
Because long-term care hospitals do not have emergency rooms, they choose which patients to admit. Medicare tries to prevent them from admitting patients who could be treated less expensively at nursing homes, but its rules are applied loosely, if at all, said Dr. Kahn of the University of Pennsylvania. “They can pick the most profitable types of patients,” Dr. Kahn said.
Moratorium
During the 1990s, as medical entrepreneurs like the Ortenzios recognized that long-term care hospitals were relatively cheap to set up and could be run profitably, companies rushed to open them. Spending on such hospitals soared to $4.5 billion in 2006, from $1.9 billion in 2001 and $398 million in 1993.
Concerned about costs, Medicare began tinkering with its rules to slow the industry’s growth. The agency limited the number of patients that hospitals-within-hospitals could admit from their hosts. It said that if patients were admitted to a long-term care hospital and then rapidly returned to a regular hospital, it would not pay multiple reimbursements.
Nonetheless, the industry continued to grow. Finally, in December 2007, Medicare instituted a three-year moratorium on new long-term care hospitals. The freeze has slowed, but not stopped, the industry’s growth. After soaring for more than a decade, Medicare spending on long-term care hospitals has been flat the last two years.
But the moratorium expires in December of this year. And even if it is extended, existing long-term hospitals will continue to admit nearly 200,000 Medicare, Medicaid and private insurance patients a year, without any proof that they match the quality of traditional hospitals, Dr. Kahn said. Despite the moratorium, he said, Medicare has never “taken steps to curb the perverse financial incentives” that drove the long-term hospital explosion.
Filed Under News | Leave a Comment
Mar
10
The New York Times, March 9, 2010, by Alex Berenson – The Senate Finance Committee has opened an investigation into patient deaths and allegations of substandard treatment at long-term care hospitals, small specialty medical centers that treat chronically ill patients.
The investigation focuses on the Select Medical Corporation, a for-profit corporation that runs 89 long-term care hospitals, more than any other company. In a letter sent on Monday to Select’s chief executive, Robert Ortenzio, the committee’s top two senators demanded that Select provide records about staffing levels and quality at its hospitals.
The committee has substantial power over long-term care hospitals because it oversees Medicare. The federal program spends almost $5 billion annually on the hospitals, providing about 60 percent of their total revenue.
An article in The New York Times last month detailed poor treatment and patient deaths at long-term care hospitals, which treat 200,000 seriously ill patients a year nationwide, but rarely have full-time physicians on staff. In one incident at a Select hospital in Kansas, a dying patient’s heart alarm sounded for 77 minutes before nurses responded. Select has said that it conducted an appropriate clinical review in the case and terminated a clinician involved in the patient’s care.
The article prompted the investigation, according to the letter, which was sent by Senator Max Baucus, Democrat of Montana, the committee’s chairman, and Senator Charles E. Grassley of Iowa, the panel’s senior Republican. The letter is not a subpoena, but companies usually respond voluntarily to such requests for information.
Select Medical said that it would cooperate fully with the inquiry. Through a spokeswoman, Carolyn Curnane, the company referred to the Times article as misleading and inaccurate and said it looked forward to providing the committee with accurate facts about the quality of care in its long-term care hospitals.
Mr. Baucus and Mr. Grassley asked Select to disclose its policies for patient monitoring, emergency situations and staffing, including physician involvement at its hospitals and staff turnover. Former employees of Select have said that the company’s hospitals are understaffed and rely heavily on temporary nurses.
The letter also requests that Select disclose information about its discharge policies. Former employees have also said that the company presses to keep patients for 25 days and then discharge them almost immediately, because patients are most profitable if they stay exactly 25 days under government reimbursement rules. At some Select hospitals, the 25th day is called the “magic day,” ex-employees say.
The company says it has a demonstrated record of providing quality care and that patients are seen daily by doctors, while facilities without doctors have doctors on call for emergencies. It added that it did not discharge or hold patients for financial reasons. In a separate letter, the senators asked that the Government Accountability Office, Congress’s investigative agency, examine federal and state oversight of all long-term care hospitals, saying that they worried the facilities might expose patients “to an unreasonable risk of harm.”
Only a few long-term care hospitals existed in the early 1980s. But more than 400 have opened nationally in the last 25 years. Experts on the treatment of critically ill patients say that growth has been driven mostly by Medicare rules that offer high payments to hospitals that treat patients for an average of 25 days or more.
Unlike other specialized hospitals, including psychiatric or children’s hospitals, long-term care hospitals do not treat specific types of patients or offer services unavailable in regular medical centers. They are defined solely by the fact that they keep patients longer than other hospitals. They are also smaller than a typical hospital, averaging about 60 beds, and do not have emergency rooms.
If their patients need surgery or suffer medical emergencies, they are usually transferred back to general hospitals.
Supporters of the hospitals say that even without staff physicians, they provide quality care and play an important role by treating patients who are too sick for nursing homes but are not improving at traditional hospitals.
The questions about long-term care hospitals center on the for-profit side of the industry, led by Select and Kindred Healthcare, another publicly traded company.
Run by Robert Ortenzio and his father, Rocco, who collectively have made $400 million since founding the company in 1996, Select tells investors that it increases its profits by monitoring staffing levels. At a presentation last week, the company said it had raised profit margins at its hospitals to 19 percent in 2009, from 16 percent in 2008, increasing cash flow by $54 million.
But former employees, state inspection reports and lawsuits paint a disquieting picture of the care that Select provides.
In 2007 and 2008, Select’s hospitals were cited at a rate four times that of regular hospitals for serious violations of Medicare rules, according to an analysis by The Times. Other long-term care hospitals were cited at a rate about twice that of regular hospitals.
Medicare has few levers against long-term care hospitals — or any hospitals. Medicare and Medicaid account for almost half of all hospital spending nationally, but Medicare cannot fine hospitals if it finds low-quality care, or force them to make staff changes. Its only remedy is to bar hospitals from the program entirely, a penalty so draconian the government rarely uses it.
Select has criticized the original article, calling its analysis faulty and noting that it treats many severely ill patients.
Since the article ran, physicians, patients and their families have contacted The Times about other disturbing incidents at Select hospitals.
According to a doctor’s deposition in a lawsuit, nurses at a Select hospital in Tulsa, Okla., injected a relatively healthy 79-year-old woman with 10 times the amount of insulin she was supposed to receive back in January 2009. They then failed to notify her doctor for at least 90 minutes after they discovered that she had fallen into a coma. The woman, Ruth Tanner, died a month later without fully regaining consciousness, according to medical records and the lawsuit.
Select Medical generally does not comment on pending lawsuits, so out of respect for the legal process and the parties involved, it will not do so in the Tanner case, the company spokeswoman, Ms. Curnane, said.
Dan Graves, an attorney for Ms. Tanner’s family, said that family members agonized after the overdose. “Now their grief and loss has been multiplied by the knowledge that other families have suffered similar tragedies because of Select’s practices.”
Filed Under News | Leave a Comment
Mar
10
FierceHealthCare.com, March 9, 2010, by Caralyn Davis
The Senate Finance Committee has launched an investigation into quality-of-care concerns at the nation’s roughly 400 long-term acute-care (LTAC) hospitals. The committee oversees the Medicare program, which pays LTAC hospitals almost $5 billion a year (60 percent of the hospitals’ total revenue).
Allegations of poor patient care, and even patient deaths, surfaced last month in an exposé by the New York Times. The Senate investigation centers on for-profit LTAC hospitals, and an early bull’s-eye has already been painted on industry leader Select Medical Corp., a Mechanicsburg, Pa.-based provider that runs 89 LTAC hospitals.
In 2007 and 2008, Select’s LTAC hospitals received four times more citations for serious Medicare violations than standard acute-care hospitals, according to the Times. Other LTAC hospitals were cited about twice as much as standard hospitals. The Times also documented several alleged incidents that spurred lawsuits against Select, including a case where nurses took 77 minutes to respond to a dying patient’s heart alarm and a case where a patient received 10 times her prescribed insulin dose, fell into a coma and later died. The Times’ unflattering portrait came just days before Select announced that income from operations grew 20.1 percent to $235.8 million for fiscal year 2009 ended Dec. 31.
On Monday, Sen. Max Baucus (D-Mont.), Finance Committee chairman, and Sen. Charles Grassley (R-Iowa), ranking member, sent a letter to Select CEO Robert Ortenzio asking the company to turn over records on staffing levels and quality of care at its LTAC hospitals. They are seeking information about the company’s discharge policies, as well as its policies on patient monitoring, emergency situations and staffing, including physician involvement and staff turnover.
Select plans to cooperate with the inquiry, according to a company representative. The firm had previously rebutted the Times article as misleading.
Separately, Baucus and Grassley also asked the Government Accountability Office to review federal and state oversight of LTAC hospitals to ensure that patients aren’t at “an unreasonable risk of harm.”
Filed Under News | Leave a Comment
Mar
10
Medscape.com, March 9, 2010, by Yael Waknine — The US Food and Drug Administration (FDA) has approved the first 20% subcutaneous formulation of immune globulin liquid (Hizentra, CSL Behring) to prevent infection in patients diagnosed with primary immunodeficiency.
Although intravenous immunoglobulins have been the mainstay of primary immunodeficiency therapy since the 1980s, many patients have difficulty tolerating the infusions because of serious adverse events or poor veins. The subcutaneous formulation allows patients to self-administer weekly infusions, using a small portable pump. Stabilization with L-proline also allows room-temperature storage, eliminating the need for refrigeration.
“With its high concentration, Hizentra is a welcome new [subcutaneous immunoglobulin] treatment option for patients managing primary immunodeficiencies,” said John Sleasman, MD, in a company news release. “Hizentra’s ready-to-use attribute will allow patients to infuse the product where and when it suits them, and physicians now have another product to select to best meet the individual needs of their patients.”
Dr. Sleasman is professor and chief of the Division of Allergy, Immunology and Rheumatology at the University of South Florida College of Medicine, Department of Pediatrics, Tampa, and one of the investigators for the company’s clinical study that led to product approval.
For the open-label, single-arm study, adult and pediatric patients previously receiving treatment with standard intravenous immunoglobulin every 3 or 4 weeks were switched to weekly doses of the 20% subcutaneous formulation during a 3-month wash-in/wash-out period, followed by a 1-year treatment period.
Results showed that 20% subcutaneous immunoglobulin was efficacious for preventing infections (annual rate, 2.76 infections/patient year), antibiotic use for treatment/prevention of infection (48.5 days/patient year), days out of work or school resulting from infections (2.06 days/patient year), and infection-related hospitalizations (0.2 days/patient year); no serious bacterial infections were reported.
Adverse events most commonly (≥5%) included injection-site reactions, headache, vomiting, pain, and fatigue.
Subcutaneous immune globulin therapy is contraindicated in patients with a history of anaphylactic or severe systemic response to immune globulins or product components such as polysorbate 80, and in those with selective immunoglobulin A deficiency with immunoglobulin A antibodies and a history of hypersensitivity. Because L-proline is used as a stabilizer, the product should not be used in patients with hyperprolinemia.
Patients should be monitored for reactions to intravenous immunoglobulins that may also occur with the subcutaneous formulation, including renal dysfunction/failure, thrombotic events, aseptic meningitis syndrome, hemolysis, and transfusion-related acute lung injury.
As with other products derived from human plasma, the risk for transmission of infectious agents (and theoretically, the Creutzfeldt-Jakob disease agent) cannot be completely eliminated
Filed Under News | Leave a Comment
Mar
10
The Lancet, Early Online Publication, 5 March 2010
doi:10.1016/S0140-6736(09)61999-1
Dr Frank R DeLeo PhD, Michael Otto PhD, Prof Barry N Kreiswirth PhD, Prof Henry F Chambers MD
Summary
Meticillin-resistant Staphylococcus aureus (MRSA) is endemic in hospitals worldwide, and causes substantial morbidity and mortality. Health-care-associated MRSA infections arise in individuals with predisposing risk factors, such as surgery or presence of an indwelling medical device. By contrast, many community-associated MRSA (CA-MRSA) infections arise in otherwise healthy individuals who do not have such risk factors. Additionally, CA-MRSA infections are epidemic in some countries. These features suggest that CA-MRSA strains are more virulent and transmissible than are traditional hospital-associated MRSA strains. The restricted treatment options for CA-MRSA infections compound the effect of enhanced virulence and transmission. Although progress has been made towards understanding emergence of CA-MRSA, virulence, and treatment of infections, our knowledge remains incomplete. Here we review the most up-to-date knowledge and provide a perspective for the future prophylaxis or new treatments for CA-MRSA infections.
Filed Under News | Leave a Comment
Mar
10
Medscape.com, March 9, 2010, by Yael Waknine — The US Food and Drug Administration (FDA) has approved a prefilled somatropin (rDNA origin) injection pen (Norditropin FlexPro, Novo Nordisk, Inc) for the treatment of growth hormone disorders in adult and pediatric patients. The product, an updated version of the company’s NordiFlex pen introduced in 2004, is expected to be available in the second quarter of 2010.
According to a company news release, the pen was designed to facilitate use by pediatric patients. Advantages include a user-friendly design that makes it easy to learn and use, and an audible click that confirms each dose dispensed; no drug reconstitution or loading of cartridges is needed. Once started, the 5-, 10-, and 15-mg/mL pens may be left at room temperature for up to 3 weeks without spoiling.
In a usability study, 100% of patients found the device easy to master, and 99% of patients responded that they found it easy to push the dose button and administer the subcutaneous injection, respectively.
“Easy to use, growth hormone delivery devices allow patients and health care professionals alike to benefit from the convenience of these pens,” noted Pinchas Cohen, MD, professor of pediatrics at the David Geffen School of Medicine at the University of California–Los Angeles and chief of endocrinology at the Mattel Children’s Hospital at the University of California–Los Angeles in the news release.
Pediatric indications for recombinant somatropin (Norditropin) include the long-term treatment of growth failure resulting from growth hormone deficiency, short stature associated with Noonan and Turner syndromes, and short stature in small-for-gestational-age children with no catch-up growth by age 2 to 4 years. It also may be used to treat adults with adult- or childhood-onset growth hormone deficiency.
Somatropin therapy is contraindicated in patients with acute critical illness following open-heart surgery, abdominal surgery, or multiple accidental traumas; acute respiratory failure; active malignancy; diabetic retinopathy; hypersensitivity to any product components; and children with Prader-Willi syndrome who are severely obese, have sleep apnea, or have severe respiratory impairment.
Adverse effects most commonly reported with somatropin therapy include headaches, myalgia, joint stiffness, hyperglycemia, glucosuria, peripheral edema, injection-site reactions/rashes, and lipoatrophy.
Other potential adverse events may include impaired glucose tolerance and unmasking of diabetes mellitus; intracranial hypertension; new-onset or worsening hypothyroidism; and slipped capital femoral epiphysis and progression of existing scoliosis in children. Somatropin also increases the risk for otitis media in children with Turner syndrome.
Patients with Noonan or Turner syndrome should be closely monitored because of an increased risk for congenital heart disease.
Clinicians should be aware of patients taking glucocorticoid medication, thyroid hormones, insulin or other antidiabetic medications, oral estrogen replacement therapy, or drugs that undergo hepatic metabolism such as corticosteroids, sex steroids, anticonvulsants, and cyclosporine.
Filed Under News | Leave a Comment