Furor Surrounds Diprivan Use for Colonoscopy
By Michael Smith, MedPage Today Staff Writer
Reviewed by Robert Jasmer, MD; Assistant Professor of Medicine, University of California, San Francisco
December 28, 2005
MedPage Today Action Points
te that the use of Diprivan (propofol) in colonoscopy is increasing, but that some insurers feel the widespread use of the medication is not medically necessary.
Note also that there is controversy between medical societies as to who should be administering the drug.
Review
INDIANAPOLIS, Dec. 28 - Doctors and patients are turning to sedation with Diprivan (propofol) for colonoscopy rather than by narcotics and benzodiazepines, the traditional approach.
Diprivan, administered intravenously, acts more quickly and provides deeper sedation than the traditional methods used to relax patients for a colonoscopy. These are effects that both patients and gastroenterologists like.
But an FDA-mandated need to have a person trained in anesthesiology present is said to add between $250 and $400 to the cost of the procedure. This is something that health insurers don't like.
So the growing popularity of Diprivan appears to be setting medical societies and health insurers against each other.
One major health insurer has said Diprivan is not medically necessary for routine colonoscopies and another may follow suit. The new clinical guidelines, according to WellPoint of Indianapolis, are partly based on a joint statement issued in 2004 by three medical societies whose members perform the procedure.
The American College of Gastroenterology (ACG) -- one of the three societies -- says WellPoint has misinterpreted the joint statement. The college says the choice of anesthetic should be left up to the physician.
The ACG is also asking the FDA to revise the package insert for Diprivan, so that a person trained in anesthesiology won't be required when it is used.
The American Society of Anesthesiologists (ASA) has fired back, charging in a letter to the FDA that the change would compromise patient safety.
Susan Miller, a spokesperson for Aetna of Hartford, Conn., notes that patient safety and quality of care are also part of the equation. Aetna is considering whether to follow WellPoint's lead and declare Diprivan not medically necessary for routine colonoscopies.
Miller said the company is currently consulting with the professional community and will decide its policy in the new year.
The key factor for WellPoint, said spokesperson Laura Stallman, is that most people don't need Diprivan. "For the majority of Americans, conscious sedation is effective and well-tolerated," Stallman said.
"Our clinical guidelines … support general anesthesia as medically necessary," she said.
In accordance with WellPoint's new guidelines, one of its health plans, Blue Cross of California, has already told practitioners it won't pay for Diprivan to be used in routine cases.
Other regional health plans, Stallman said, will decide whether to follow the company's medical guidelines based on local conditions.
WellPoint is the nation's largest health insurer, and Aetna is third largest. The second largest, UnitedHealth Group of Minneapolis, and the fourth largest, Cigna of Philadelphia, both generally cover anesthesiology services during colonoscopies.
WellPoint's move drew fire from the ACG's past president, John Popp, M.D., of Columbia, S.C., who said in a letter to WellPoint CEO Larry Glasscock that the society has "serious concerns" about the decision not to pay for anesthesiologists.
The so-called Tri-Society Statement, approved by the ACG, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy, said a minority of patients must have general anesthesia, but it's not needed routinely.
However, "a significant number of patients will need anesthesiologist monitoring and/or general anesthesia," Dr. Popp wrote. "The treating physician is the appropriate party to make such a determination."
Taking the decision out of the hands of the doctor, Dr. Popp wrote, raises "a legitimate question whether your company may be violating one or more state laws relating to competency and credentialing to practice medicine."
WellPoint's Stallman said company officials are "reaching out" to Dr. Popp to try to clear up any misunderstanding. Dr. Popp was not immediately available for comment.
The ACG has asked the FDA to change the package insert for Diprivan, which says it can be "administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure."
In a letter to the FDA, the ASA responds that such a change would be dangerous.
"ASA and its members strongly believe that the requested change is ill-advised," wrote ASA president Eugene P. Sinclair, M.D., of Milwaukee. "It is not supported by sound clinical data and is not in the best interests of patient safety."
The letters chide the ACG for its focus on the cost of using the drug. Even within the college, the ASA says, "many gastroenterologists who do use anesthesia providers apparently are unwilling to sacrifice patient safety for the sake of incrementally higher profit margins."
The use of Diprivan may be controversial, but the evidence indicates it's going to keep going up.
In a study published earlier this year, 22% of physicians who responded to a Web survey said they routinely use Diprivan for colonoscopy and 43% said they planned to start using it within a year.
"A lot of private practices are interested in using it," said Ashley Faulx, M.D., of University Hospitals of Cleveland, because patients go under and recover more quickly, which may increase patient turnover.
Primary source: Gastrointestinal Endoscopy
Source reference:
Faulx AL et al. The changing landscape of practice patterns regarding unsedated endoscopy and propofol use: a national Web survey. Gastrointest Endosc. 2005 Jul;62(1):9-15.
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