Improved medical sedation, interrupted

In 1998, anesthesiologist Dr. Robert McIntyre and I launched a new sedation technique for gastroenterology that provided guaranteed painless exams, rapid and smooth recovery and greater practice efficiency. Propofol, as the newcomer, solidly out-performed the traditional tranquilizer/narcotic combination.

Since this bright beginning, the local gastroenterology group has achieved more than 84,000 patients with NAPS — nurse-administered propofol sedation. The recent global safety study tallied 646,080 patients from 28 sites and 10 countries. Seven of these sites trained in Medford. All four national gastrointestinal societies robustly endorsed NAPS in December 2009.

Ironically, also last December, despite extensive published evidence, the federal Centers for Medicare & Medicaid services, which oversees Medicare and Medicaid, announced NAPS can no longer be performed. The use of propofol in procedural sedation would require an anesthetist. There was no pre-announcement or comment period. The origins of this dramatic unfunded mandate have not been divulged, but if you follow the money, GI sedation is worth $8 billion a year if an anesthesiologist or certified respiratory nurse anesthetist is used ($200 to $1,000 per patient). NAPS results in no sedation cost.

If you have private insurance or none, it does not matter: CMS controls all of the facilities in the U.S. Imagine: one backroom committee decapitating endoscopist-directed propofol and sedation vitally needed for cardiology and pulmonary procedures, in the emergency room, in the Rogue Valley and from sea to shining sea.

CMS is basing its stance on the FDA's 20-year-old package insert for propofol. The FDA governs drug approval and how the drug can be marketed by pharmaceutical companies. Its label becomes the insert.

Physicians and nurses use drugs off-label frequently, and legally so. The off-label use of drugs may be the only therapy for a condition, the therapy of choice or the customary standard of care, and certainly plays a major role in innovations, such as the NAPS global success story.

Curtis Rosebaugh, M.D., director of the FDA's Office of Drug Evaluation, said in July 2008, "I should point out that the wording in the propofol labeling states 'should,' not 'must,' and therefore does not restrict usage by health care providers with training outside of anesthesia if they feel they are competent ... ."

Voices such as his have been outvoted by strong representation at the FDA by the usual suspects with huge conflicts of interest. Now CMS, controlling the purse strings, has disallowed the off-label use of a drug without any basis in published literature.

Do you need a fiberoptic examination down your nose into your lungs? One local practitioner told me he would stop this procedure if propofol disappears.

Next time you are in the emergency room with a dislocated shoulder, in need of urgent (yet awake) electrical shock to your chest, or any of a myriad of painful situations, just imagine a committee laden with hidden agendas debating the meaning of "must" versus "should."

This month's issue of the magazine Gastrointestinal Endoscopy projects a doubling of the use of anesthetists in GI sedation from 2007 to 2015, substantially increasing costs and straining scarce health care resources: " ... these results suggest that clinicians, payors, policy makers and other interested stakeholders should consider more cost-effective alternatives ... ."

What is clear is that endoscopist-directed propofol is decidedly safer than GI physicians using yesteryear's sedatives, the national shortage of anesthesia providers would be exacerbated by using them in routine cases, and only a finite amount of health care dollars exists in these times of austere national fiscal concerns. NAPS also avoids costly hospital delays.

The four national GI societies of the U.S. and the three emergency department societies have registered their requests for CMS to reverse its manifesto. A letter dated July 8 from CMS says it is reconsidering.

As I write this in Jeddah, Saudi Arabia, on the shores of the Red Sea, I am preparing to talk about this local and global issue. To illustrate how large 646,080 patients is, I will show a view of football fans in the "Big House" in Ann Arbor, Mich. from a talk at that medical school one year ago. It would require filling the stadium six times to reach this staggering number.

If we could continue NAPS in the Medford hospitals, in less than three years, our 84,000 tally would grow to fill that stadium. Since we have collectively done more NAPS cases than the population of our city limits, we are globally unique and have a special responsibility to speak up.

Who wants "Rodeo Endoscopy" (patient thrashing), given the safety and precision of NAPS? Please help turn around this regulatory theater of the absurd with your letters and e-mails. I will forward them to CMS. Thanks.

John A. Walker, M.D., is a partner at Gastroenterology Consultants in Medford. E-mail him at

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