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| Manufacturer Settles Kickback Case for $10 Million
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As part of four settlements to resolve allegations of illegal kickbacks and violations of the Physician Self-referral Law, equipment manufacturer Lincare has paid the federal government $10 million and signed a five-year corporate integrity agreement.
"We are pleased to have resolved these matters with the government," says Lincare chairman and CEO John P. Byrnes in a statement. "Lincare fully cooperated with the government during the course of their inquiries."
As a result of investigations conducted between January 1995 and March 2004, the Office of Inspector General and the U.S. Department of Justice alleged that Lincare, which manufactures CPAP machines, nebulizers, ventilators and other devices for home use, engaged in a nationwide scheme to induce physicians to refer their patients to Lincare. Offering such gifts as tickets to sporting and entertainment events, gift certificates, rounds of golf, golf equipment, fishing trips, meals, advertising expenses and office and medical equipment, Lincare allegedly disguised the gifts as payments under supposed consulting agreements. The OIG further alleged that Lincare violated the Self-referral Law by accepting referrals from participants in the illegal consulting agreements.
"This significant settlement is an important example of OIG's continuing effort to eliminate illegal kickback practices and violations of the Self-referral Law," said Inspector General Daniel R. Levinson. "OIG will continue to pursue aggressively those who undermine the integrity of the Medicare program."
Medical device manufacturers also have their own safeguards in place, in the form of a voluntary code of conduct, says Alan R. Carlton, JD, chief corporate counsel and a vice president at United States Surgical/Valleylab in Norwalk, Conn.
"If you suspect that you've been offered an inducement to buy or lease that may violate the Anti-kickback Statute," he advises, "consult your facility's counsel to determine if your accepting the offer could violate the law."
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| Study Recommends Inpatient Tonsils for Infants
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A study of pediatric patients undergoing adenoidectomies and tonsillectomies as treatment for obstructive sleep apnea syndrome shows that children younger than 3 years are at greater risk for post-surgical respiratory complications than children slightly older.
As a result, the youngest pediatric patients should be admitted for hospital stays for the procedures rather than undergoing them outpatient, says the study, which appears in May's Archives of Otolaryngology — Head and Neck Surgery.
Researchers at the Cincinnati Children's Hospital Medical Center reviewed the cases of 2,315 adenotonsillectomy patients younger than 5 who'd had the procedure done at center between June 1999 and May 2001.
While 6.4 percent of the total patient sample developed respiratory complications after the surgery, patients aged 3 to 5 suffered complications only 4.9 percent of the time. Patients younger than 3 years, however, suffered complications 9.8 percent of the time.
"Our results support hospital admission for all patients younger than 3 years undergoing adenotonsillectomy for treatment of OSAS," the researchers write.
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| Studies Skeptical of Prepping Practices
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It's not uncommon for surgical personnel seeking to reduce the incidence of post-surgical site infections to recommend pre-operative antibacterial showers for their patients and to remove hair at the surgical site before incision. Two new studies, however, suggest that these practices are not as effective as is commonly believed.
In the showering study, researchers reviewed six randomized controlled trials that compared the outcomes of more than 10,000 patients who either washed with 4% chlorhexidine gluconate, a placebo or bar soap, or did not wash at all. The difference in outcomes was not statistically significant. "This review provides evidence of no benefit for pre-operative showering or bathing with chlorhexidine over other wash products, to reduce surgical site infection," the researchers write.
In the hair removal study, researchers reviewed eleven trials involving more than 5,000 patients that compared outcomes after several hair removal scenarios using razors, clippers and depilatory creams, or not removing hair at all.
"The evidence finds no difference in SSIs among patients who have had hair removed prior to surgery and those who have not," the researchers write. "If it is necessary to remove hair, then clipping results in fewer SSIs than shaving using a razor.
"There is insufficient evidence regarding depilatory cream compared with shaving using a razor," they continue. "There is no difference in SSIs when patients are shaved or clipped one day before surgery or on the day of surgery."
While the two practices have become standard surgical hygiene, the studies' authors suggest that reconsidering them may result in time and cost benefits.
The studies appear in a recent issue of The Cochrane Library, a publication of the international, non-profit healthcare researcher The Cochrane Collaboration.
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| News and Notes
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It's not uncommon for surgical personnel seeking to reduce the incidence of post-surgical site infections to recommend pre-operative antibacterial showers for their patients and to remove hair at the surgical site before incision. Two new studies, however, suggest that these practices are not as effective as is commonly believed.
In the showering study, researchers reviewed six randomized controlled trials that compared the outcomes of more than 10,000 patients who either washed with 4% chlorhexidine gluconate, a placebo or bar soap, or did not wash at all. The difference in outcomes was not statistically significant. "This review provides evidence of no benefit for pre-operative showering or bathing with chlorhexidine over other wash products, to reduce surgical site infection," the researchers write.
In the hair removal study, researchers reviewed eleven trials involving more than 5,000 patients that compared outcomes after several hair removal scenarios using razors, clippers and depilatory creams, or not removing hair at all.
"The evidence finds no difference in SSIs among patients who have had hair removed prior to surgery and those who have not," the researchers write. "If it is necessary to remove hair, then clipping results in fewer SSIs than shaving using a razor.
"There is insufficient evidence regarding depilatory cream compared with shaving using a razor," they continue. "There is no difference in SSIs when patients are shaved or clipped one day before surgery or on the day of surgery."
While the two practices have become standard surgical hygiene, the studies' authors suggest that reconsidering them may result in time and cost benefits.
The studies appear in a recent issue of The Cochrane Library, a publication of the international, non-profit healthcare researcher The Cochrane Collaboration.
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| Correction
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It's not uncommon for surgical personnel seeking to reduce the incidence of post-surgical site infections to recommend pre-operative antibacterial showers for their patients and to remove hair at the surgical site before incision. Two new studies, however, suggest that these practices are not as effective as is commonly believed.
In the showering study, researchers reviewed six randomized controlled trials that compared the outcomes of more than 10,000 patients who either washed with 4% chlorhexidine gluconate, a placebo or bar soap, or did not wash at all. The difference in outcomes was not statistically significant. "This review provides evidence of no benefit for pre-operative showering or bathing with chlorhexidine over other wash products, to reduce surgical site infection," the researchers write.
In the hair removal study, researchers reviewed eleven trials involving more than 5,000 patients that compared outcomes after several hair removal scenarios using razors, clippers and depilatory creams, or not removing hair at all.
"The evidence finds no difference in SSIs among patients who have had hair removed prior to surgery and those who have not," the researchers write. "If it is necessary to remove hair, then clipping results in fewer SSIs than shaving using a razor.
"There is insufficient evidence regarding depilatory cream compared with shaving using a razor," they continue. "There is no difference in SSIs when patients are shaved or clipped one day before surgery or on the day of surgery."
While the two practices have become standard surgical hygiene, the studies' authors suggest that reconsidering them may result in time and cost benefits.
The studies appear in a recent issue of The Cochrane Library, a publication of the international, non-profit healthcare researcher The Cochrane Collaboration.
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