The FDA's Advisory Committee on Anesthetic and Life Support Drugs last week recommended the approval of the IV sedative fospropofol disodium (Aquavan) for use during diagnostic procedures. The recommendation sets the stage for the FDA's final review and approval of the drug for the U.S. market, which could present a viable alternative to propofol for establishing minimal and moderate sedation.

Aquavan is converted to propofol after injection by the enzyme alkaline phosphatase. That conversion minimizes Aquavan's initial concentration levels in the bloodstream, creating a gradual increase in the patient's depth of sedation and a safer alternative to propofol's rapid onset, according to Mary Lynne Hedley, PhD, executive vice president of Eisai Corporation of North America, Aquavan's U.S. marketer. Eisai hopes Aquavan will gain FDA approval without a monitored anesthesia care requirement, letting non-anesthesia providers administer the drug in a variety of healthcare settings.

The advisory committee, however, ruled that healthcare professionals without anesthesia training cannot safely administer Aquavan and called for further testing of the drug in a variety of patient populations, including the elderly and those who weigh less than 60kg.

FDA reviewers typically follow the committee's recommendations, but are not bound to its rulings. "We are encouraged by ALSDAC's support of the efficacy and safety results of fospropofol disodium demonstrated in our clinical studies, and we look forward to continuing our discussions with the FDA as they finalize their review of our application," says Dr. Hedley, who expects a FDA ruling by July 26. "We believe the clinical trial data support the use of this product by anesthesiologists and non-anesthesia health care professionals."

Daniel Cook

CMS has been given the green light to enforce its anti-markup rule barring physicians from billing for off-site anatomic pathology services after a federal judge dismissed a lawsuit challenging the rule.

U.S. District Court Judge Rosemary M. Collyer ended a temporary injunction placed on the anti-markup provision by ruling that the court lacked jurisdiction to take up a challenge against it, brought by three urology practice groups and the Arlington, Texas-based pathology lab management company Uropath LLC.

Judge Collyer determined that, under section 405(h) of the Medicare Act, the plaintiffs should have channeled their complaint through the Department of Health and Human Services before taking it to court. She also ruled that, since they do not participate in Medicare, Uropath and its clinical director had no legal standing to challenge the provision.

With CMS free to enforce the rule, physicians are now barred from marking up the technical or professional components of anatomic pathology tests that are not performed in the same building (as defined by the Stark law) as the billing practice.

The provision aims to close a perceived loophole that had let physician groups set up off-site pathology "pods" and bill for the diagnostic services performed there. Critics of the controversial practice say it amounts to fee-splitting and encourages overutilization. Jane Pine Wood, JD, an attorney at McDonald Hopkins in Dennis, Mass., says that although the rule does not ban path pods, it will make many of them financially infeasible.

In addition to the federal crackdown, states are also looking to curb the practice. Just last month, Missouri's state senate passed a bill banning markups for anatomic services.

Irene Tsikitas

A minimally invasive bariatric procedure for patients who haven't found success with other weight loss surgeries is gaining ground in the United States, while other incisionless bariatric procedures are on the horizon.

Several surgeons across the country have performed endoluminal transoral tissue approximation and ligation of the stomach pouch to decrease the size of the pouch and limit the amount of food that patients can eat. "They regain sense of satiety because they get a pouch that doesn't stretch," says Paul Cirangle, MD, a bariatric surgeon in San Francisco who has performed the procedure. Dr. Cirangle used the Stomaphyx device, which was approved by the FDA in April 2007, to create and fasten plications in the stomach pouch by way of the esophagus. The 30-minute outpatient procedure is targeted at patients who have not been able to lose the desired amount of weight through gastric bypass, duodenal switch and vertical sleeve gastrectomy surgeries. Most cases so far have been elective, costing the patient $8,500 to $15,000. The device, developed by EndoGastric Solutions of Redmond, Wash., costs $1,500, says Dr. Cirangle.

U.S. operating rooms may also see the arrival of other incisionless bariatric procedures over the next few years. A device for transoral gastroplasy (TOGA) manufactured by Satiety, Inc., of Palo Alto, Calif., is currently undergoing a Phase III trial in the U.S. and Belgium. If all goes well, the TOGA device could be on the U.S. market in 2011, says Rachel Croft, a spokeswoman for Satiety. In the TOGA procedure, the surgeon goes through the esophagus to gather and staple a sleeve in the stomach that restricts the amount of food that enters.

Also under development is the EndoBarrier, a liner endoscopically inserted into the small intestine to create an impermeable barrier that prevents food from coming into contact with the intestine wall, and thus blocks the absorption of nutrients into the blood. The developer, GI Dynamics of Lexington, Mass, is currently recruiting U.S. patients for a phase II trial.

Kent Steinriede