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| Study Backs ASCs in Proposed Payment Restructuring
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As owners and administrators of ASCs rally against the new ASC payment policy proposed by CMS, a study released by the Medicare Payment Advisory Commission offers support to their cause. According to MedPAC, the differences between costs and quality outcomes of cataract and colonoscopy cases performed in ASCs and hospital outpatient departments are insignificant.
The findings come days before CMS's Nov. 6 deadline for public comment on the proposed policy change, which will eliminate grouper payments in favor of the APC relative weights used in hospitals' Outpatient Prospective Payment System. CMS, required by law to develop a budget-neutral payment system for ASC services by 2008, recently announced its decision to pay ASCs 62 percent of what hospitals receive for the same procedures.
Michael Romansky, Washington counsel for the Outpatient Ophthalmic Surgery Society, notes that the study suggests hospitals treat more clinically compromised patients, but that ASCs' results are equal to or better than those of HOPDs when measured by adverse outcomes. "There is absolutely no support for the proposition that either hospitals' patient mix or their outcomes support such disproportionately higher payment rates than surgery centers," he says. "I think that this lends credence to a ASC/HOPD conversion factor that is higher than 62 percent."
Researchers for MedPAC examined data for 77,294 Medicare patients who underwent cataract surgery in 2001, 47 percent of whom received surgery in an HOPD and 53 percent in an ASC. A similar review of 90,890 colonoscopies showed that 70 percent took place in an HOPD and 26 percent occurred in an ASC.
Cataract patients fared better in ASCs; those undergoing the procedure in hospitals were more likely to develop endophthalmitis. Patients who underwent colonoscopies had better outcomes in hospitals, however, as they were twice as likely to suffer a perforation in an ASC, although these complications were rare in both settings, occurring one to two times per 1,000 cases.
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| Reusing SUDs May Pose Risk to Patients
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Nearly half of reprocessed, reused single-use arthroscopic shaver blades had detectable levels of protein and nearly two-thirds had detectable levels of nucleic acid, according to a study published in the October issue of Arthroscopy: The Journal of Arthroscopic & Related Surgery.
The purpose of the study, conducted by researchers at Loma Linda University in California, was to evaluate the level of contaminants on, as well as the quality of, reprocessed shaver blades. Researchers used a spectrometer to assess the nucleic acid and protein on seven new shaver blades and 27 shaver blades that had been mechanically cleaned, tested for function and sterilized with ethylene oxide. Thirteen still showed protein and 17 still showed nucleic acid after reprocessing.
"This is a highly significant evidence-based study which should draw the needed attention to the risks of using reprocessed, single-use-only arthroscopic shaver blades in surgery," says Jerry Goodman, the senior vice president of Smith & Nephew Endoscopy, which funded the first phase of the study (the university funded the second phase). "Patients should be confident that they are receiving the safest care and best clinical outcomes possible. This study reinforces our position that hospitals and medical facilities around the world should carefully consider whether using a reprocessed, single-use-only arthroscopic shaver blade is in the best interest of the patient."
In addition to the possible infection risks, there may be a safety risk. All 20 of the reprocessed blades that were manufactured with teeth (and could therefore be visually evaluated) showed some level of damage or wear, the study says. In addition, menisci cut with reprocessed shavers showed rougher edges than did menisci cut with new shavers, according to researchers.
"To make an informed decision regarding the use of reprocessed shaver blades," the researchers write, "surgeons will want to know the level of contamination on, and the quality of, reprocessed shaver blades."
However, the "inadequate sample size" and the questions left unanswered by the study make the results suspect, says the Association of Medical Device Reprocessors.
"[It] fails to document the chain of custody for the reprocessed blades; fails to document the hospital where the blades were allegedly used; and, most importantly, fails to document any reports of patient injury, infection or other harm related to arthroscopic shaver blades reprocessed in according with [FDA] requirements," says the AMDR in a statement. "We believe the answers to these questions will make it clear that the [study] ... is meaningless as an assessment of the degree to which reprocessed devices are clean and functional."
Reprocessors must submit the same paperwork a manufacturer would have to submit to the FDA to gain 510(k) approval to manufacture and distribute a new device. Those companies must be able to prove they have a process for thorough cleaning, disinfection and sterilization of the device; that the process does not harm the device in any way; and that the device will function as a new one would.
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| Transoral Weight-loss Surgery Shows Promise in Early Trials
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A new, less-invasive bariatric procedure that takes only an hour to perform appears to achieve similar weight loss, require less recovery time and result in dramatically reduced complications when compared to existing surgical options, according to the results of a preliminary study presented at the annual meeting of the American College of Gastroenterology and United European Gastroenterology Week.
The transoral gastroplasty, developed by Palo Alto, Calif.-based Satiety, Inc., and tested by researchers at Erasme University Hospital in Brussels, Belgium, is an endoscopic procedure in which the physician introduces a stapling device transorally and creates a restrictive pouch at the entry of the stomach. The effect is anatomically similar to other restrictive procedures, which physically limit the amount of food a patient can eat.
"I was extremely impressed that patients [in the trial] had almost no discomfort," says Jacques Devière, MD, PhD, the chairman of the department of gastroenterology at Erasme University. "Most were discharged the day after procedure, even though it was a pilot trial in which they were carefully observed. Two days later, they were ready to go back to work. [That result is] even better than for laparoscopy; our preliminary experience indicates this could be an outpatient procedure."
Twenty one patients, 17 of them female, ranging in age from 22 to 57 years old and suffering from morbid obesity underwent the procedure in two centers over a four-month period. Transoral gastroplasty was performed under general anesthesia with intubation; follow-ups were planned at one week, one month and three months. There were no immediate complications or device- or procedure-related severe adverse events and all discharges occurred within 48 hours of the procedure. Mild to moderate adverse events included pain (five patients), nausea (four), vomiting (four), dysphagia (three) and pharyngitis (one), all lasting less than five days. At one month, patients had lost a median of 16 pounds (the range was nine to 28) representing a median of 16 percent (range: 7 to 25 percent) of their weight. The six patients already seen at three months had lost a median of 21 percent (range:14 to 29 percent) of their weight.
Previous attempts at developing a transoral weight-loss procedure have been disappointing, the study abstract says. The transoral gastroplasty, if it continues to produce successful results, would allow expansion of the current eligible patient population because of the recovery and risk profiles. In addition, it could be more appropriate on patients who are not eligible for surgery because they are too sick from co-morbidities, too large for surgical access, or their health is adversely affected by obesity but they don't meet the surgical BMI requirements (that is, greater than 40 or greater than 35 with co-morbidities).
"It seems it can be done without any significant complication, but this is still just a pilot study (of an investigational device not yet approved by the FDA or European regulatory agencies) and it's too early to tell for sure," says Dr. Devière. Still, "this is, for me, the [most] major advancement I've seen in abdominal bariatric surgery in the last 10 years."
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| News and Notes |
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DO CIGARETTES HINDER TISSUE HEALING? Research by orthopedic surgeons at Washington University School of Medicine in St. Louis suggests that the tendon-to-bone healing that follows rotator cuff repair surgery may be compromised by, and may re-injure or fail due to, a patient's exposure to nicotine. For their study, published in the September issue of The Journal of Bone & Joint Surgery, the researchers observed 72 rats who'd undergone the surgery on their shoulders and who were implanted with miniature subcutaneous pumps which dispensed nicotine to some of the rats and saline to the others. The rats exposed to nicotine suffered persistent inflammation in the shoulder joint, weaker tissue recovery and inferior healing. While the amount of nicotine delivered equated to that of a pack-a-day smoker, the researchers say their study may have underestimated the results, given that the rats were not dosed with carbon monoxide, tar or other cigarette contaminants and that they'd only had a few weeks' exposure, not long-term smoking before and after surgery.
THE BLOOD-THINNING PROPERTIES OF ASPIRIN are commonly used to prevent post-op blood clots — by some providers, to some patients. A recent study shows a "marked variability" among surgical specialties as to whether aspirin is administered and a lack of research on whether it's effective after all types of surgery. In the study, presented at the Canadian Society of Cardiac Surgeons' annual meeting last week, researchers from McMaster University in Hamilton, Ontario, surveyed 900 orthopedic, general and vascular surgeons on the subject. Noting that most studies on aspirin's use and effects had been conducted on cardiac patients, to the exclusion of patients undergoing other types of surgery, the researchers also point out the disparate views between the three specialties. "They are doing very different things and there is no consistency," one writes. "They are uncertain if there is a real benefit and if that benefit outweighs the risk, even if there is, in fact, a risk."
SURGICAL SUPPLY MANUFACTURER DEPUY SPINE, INC., has established the first spine arthroplasy registry. Top spine centers will participate in the Centers for Arthroplasty Research and Education in Spine to document clinical outcomes, further education and research and help improve insurance coverage and reimbursement for artificial disc replacement. The company says the program will include the first-ever spine arthroplasty registry to track the clinical and economic outcomes of patients receiving disc replacements, with data collection and publication overseen by a committee of spine surgeons. "CARES will contribute important clinical data that will advance the science of spine arthroplasty and demonstrate best practices," says Richard Toselli, MD, worldwide vice president of clinical evidence and external relations at DePuy Spine. |
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