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.
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.
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.
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.
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.”
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.”
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
The Lancet, Early Online Publication, 5 March 2010
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.
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.
Medscape.com, March 9, 2010, by Laurie Barclay MD — Prednisolone, 40 mg once daily for 1 week, does not improve outcome in hospitalized patients with community-acquired pneumonia (CAP), according to the results of a randomized, double-blinded, clinical trial reported online in the February 4 issue of the American Journal of Respiratory and Critical Care Medicine.
“Some studies have shown a beneficial effect of corticosteroids in patients with [CAP], possibly by diminishing local and systemic anti-inflammatory host response,” write Dominic Snijders, MD, from Medical Center Alkmaar in Alkmaar, the Netherlands, and colleagues.
In this trial, 213 hospitalized patients meeting standard clinical and radiologic criteria for CAP were randomly assigned to receive 40 mg of prednisolone for 7 days or placebo, in addition to antibiotics. The main endpoint of the study was clinical cure at day 7, and secondary endpoints were clinical cure at day 30, length of stay, time to clinical stability, defervescence, and C-reactive protein (CRP). CURB-65 and Pneumonia Severity Index (PSI) were used to score disease severity.
At enrollment, CURB-65 was more than 2 (25.4%) in 54 patients, and 93 patients (43.7%) were in PSI class IV to V. Clinical cure rates were 80.8% (84/104) at day 7 and 66.3% (69/104) at day 30 in the prednisolone group vs 85.3% (93/109; P = .38) and 77.1% (84/109; P = .08) in the placebo group, respectively.
“The results of this study do not close the debate addressing the role of systemically administered corticosteroids for CAP, especially for those patients with severe CAP requiring ICU [intensive care unit] admission,” Sean K. Gorman, BScPharm, ACPR, PharmD, associate professor of pharmacy at Dalhousie University and clinical coordinator of critical care at Capital Health in Halifax, Nova Scotia, Canada, told Medscape Pulmonary Medicine when asked for independent comment. “However, it does support the recommendation that corticosteroids should not be utilized solely for the treatment of CAP.”
Defervescence was more rapid, and decline in serum CRP levels was faster in patients receiving prednisolone vs patients receiving placebo. In patients with severe pneumonia, subgroup analysis showed no differences in clinical outcome. The prednisolone group was more likely than the placebo group to have late failure occurring more than 72 hours after admission (20 [19.2%] vs10 [6.4%]; P = .04). The groups did not differ in adverse events, which were few in both groups.
“The study design (prospective, randomized, double-blind placebo-controlled study with allocation concealment) can be considered a strength of this study,” Dr. Gorman said. “The study also appeared to be statistically powered to assess for a clinically important difference in the primary outcome (clinical cure at 7 days). Another strength of this study was that it primarily looked at a clinically meaningful endpoint, rather than surrogates of inflammation, for example.”
Limitations noted by the study authors include lack of assessment of adrenal function; use of clinical cure as a subjective primary outcome; possible underrepresentation of patients with chronic obstructive pulmonary disease, limiting generalizability to patients with CAP and chronic obstructive pulmonary disease; and possibly insufficient power for all outcomes. In addition, prednisolone in a once-daily dosage may be insufficient to establish effective serum levels for a 24-hour period.
“One potentially important limitation was that the 2 study groups appeared unbalanced at baseline; for example, 8% fewer patients in the placebo group were admitted to an intensive care unit compared to the prednisolone group,” Dr. Gorman said. “This may suggest that the patients randomized to prednisolone had a higher degree of illness at baseline that may help to explain the lack of a treatment effect favouring prednisolone. Also, more patients in the placebo group had chronic heart disease.”
Other issues with generalizability noted by Dr. Gorman are that the study was conducted in only 1 hospital in Europe, only a small proportion of all patients included in this study were considered to have severe CAP, and few patients required mechanical ventilation.
“It would also have been useful to report the proportion of patients in each group who received early and appropriate antibacterial therapy for CAP,” Dr. Gorman said. “Methylprednisolone… may have slightly greater glucocorticoid and less mineralocorticoid activity than prednisolone, but the clinical relevance of this slight difference is not clear. Finally, almost 20% of all patients did not complete the study treatment course; however, the breakdown between groups was not reported; therefore total exposure to the intended corticosteroid is not known.”
On the basis of their findings, the study authors concluded that prednisolone, 40 mg once daily for 1 week , did not improve outcome in hospitalized patients with CAP but that a benefit could not be excluded in more severely ill patients. Because prednisolone is associated with increased late failure and lack of efficacy, they did not recommend it as routine adjunctive treatment in CAP.
“I agree that corticosteroid therapy should not be used for the treatment of isolated CAP because of the paucity of high quality evidence revealing an important effect on meaningful clinical outcomes of pneumonia,” Dr. Gorman said. “Of equal importance, the adverse drug events associated with systemic corticosteroids are well-documented; therefore the known risks outweigh the proven benefits (or lack thereof) at this time.”
Additional Research Needed
Regarding additional research, Dr. Gorman suggests a large, multicenter, prospective, randomized, placebo-controlled trial in patients in the ICU with severe isolated CAP requiring invasive positive pressure mechanical ventilation.
“The intervention corticosteroid should be administered early and should involve a short course of parenteral stress-dose corticosteroids,” Dr. Gorman concluded. “Survival, duration of mechanical ventilation, ICU length of stay, clinical cure, and adverse drug events (such as incidence of ICU delirium, hyperglycemia, neuromuscular dysfunction) would be endpoints of primary interest.”
AstraZeneca supported this study. The study authors and Dr. Gorman have disclosed no relevant financial relationships.
Am J Respir Crit Care Med. Published online February 4, 2010.
Medscape Medical News from the:
Medscape.com, March 9, 2010, by Michael O’Riordan (San Francisco, California) — Weight cycling, where an individual’s body-mass index (BMI) fluctuates during a two-year period, is associated with an increased risk of cardiovascular disease among normal-weight individuals, according to the results of a new study . These weight cyclers have a risk of adverse events similar to individuals who are overweight, while overweight individuals who cycled did not experience an additional increased risk of cardiovascular events over and above the risk associated with their increased weight, report investigators.
“We were looking at the overall weight status–how heavy the individual was between the ages of 40 and 55 years–and whether or not the weight went up and down during that period,” lead investigator Dr Molly Waring (University of Massachusetts Medical Center, Worchester) told heartwire . “We found that compared with people who were normal weight, or pretty steady weight, the normal-weight individuals whose weight went up and down during the two-year period, as well as those who were overweight and obese, all had a higher risk of cardiovascular disease and death.”
The results of the study were presented here this week at EPI|PNAM 2010, the Cardiovascular Disease Epidemiology and Prevention and Nutrition, Physical Activity, and Metabolism 2010 Conference.
Weight Across Time Rather Than a Point in Time
To heartwire , Waring said the purpose of the study was to examine patients’ weight across a spectrum of years rather than a point in time to determine whether changes in weight influenced their health risk. The thinking, she said, was that a patient’s weight at age 40 or 50 was less relevant than weight over the course of a lifetime.
Using data from the Framingham Heart Study, the researchers quantified the effect of overall weight status and weight cycling in 1429 participants aged 40 to 55 years old. Weight status and weight cycling was categorized using component scoring that allowed researchers to capture the weight patterns across middle age. In this study, weight cycling was defined as a change of one BMI unit within the two-year period. That works out to be about five pounds for an individual who is five feet tall and seven pounds for six-foot tall male, said Waring.
Results showed that compared with an overall normal-weight trajectory without weight cycling, normal-weight individuals whose weight went up and down over the study period had a 50% greater risk of cardiovascular disease events and a 40% greater risk of cardiovascular mortality. These normal-weight cyclers were also at a significantly increased risk of cerebrovascular accidents and coronary heart disease events when compared with normal-weight individuals whose weight did not fluctuate.
Risks of Cardiovascular Disease and Cardiovascular Mortality
|Events||Adjusted hazard ratio (95% CI)|
|Cardiovascular disease events|
|Normal weight, no cycling||Referent|
|Normal weight, cycling||1.5 (1.2–2.0)|
|Overweight, no cycling||1.7 (1.3–2.2)|
|Overweight, cycling||1.8 (1.4–2.2)|
|Normal weight, no cycling||Referent|
|Normal weight, cycling||1.4 (1.0–2.0)|
|Overweight, no cycling||1.3 (0.9–2.0)|
|Overweight, cycling||1.6 (1.1–2.2)|
Comparatively, overweight individuals who maintained a constant weight and those whose weight cycled during middle age had similar risks of cardiovascular, cerebrovascular, and coronary heart disease events. In addition, they had similar risks of cardiovascular and overall mortality.
“Among people who are overweight, those whose weight varied within the two-year period were not at any higher risk of cardiovascular disease and death than those overweight individuals whose weight remained steady,” said Waring. “I think that’s a positive finding from the study, because we know how difficult it is for patients to lose weight and to keep it off. It’s encouraging in that if they are trying to lose weight but gain it back because they’re not able to maintain the lifestyle changes, it’s not putting them at greater risk. The message is to keep trying.”
For normal-weight patients, this study emphasized the importance of keeping the weight off, because even periods of normal weight won’t protect against cardiovascular disease events if the patients’ weight fluctuates up and down, she said.