Tuesday, July 10, 2007

Limits ot Technology - Limits of Government Intervention in Technological Assessment

The Case of Catheter Ablation for Atrial Fibrillation

In 1976 Dr. Howard Hiatt, dean of the Harvard School of Public Health, give a speech advocating a U.S. technological assessment center before any medical product went to market.

Joseph Califano, secretary of Health and Human Services, chimed in. He whined more CAT scanners existed in Los Angeles than in Canada, as if that was a bad thing.

The rest is history. Neurosurgeons recognized CAT scans as a superior technology. Immediately they deployed CAT scans to spot brain tumors. MRIs followed CAT scans. The scans received the same warm reception as CAT scans among physicians. In 2001 a survey of 225 general internists published in Health Affairs ranked the top 30 major medical innovations, and MRI and CAT scans came out number one.

Government can’t control technology markets once doctors and patients spot a superior device, even if the device costs more than government thinks it can afford and even studies of safety and effectiveness have yet to be published..

Take the case of catheter ablation of heart atria sites that spark fibrillation. Atrial fibrillation afflicts 2.2 million Americans. It’s a leading cause of strokes and heart failure. Doctors think ablation is more effective than open heart surgery and multiple drug treatments. Consequently, thousands of ablations have been performed since 2000 – even though federal regulators haven’t approved the procedure and don’t pay for it.

Where there’s a will, there’s a way. Catheter ablation is moving faster than the federal approval process. Doctors and patients are saying, in effect, “To hell with the clinical trials. This ablation procedure works.” And “We” the patients, will demand it, and you, the doctor, had better provide it, or we’ll go elsewhere.

Doctors and hospitals are inventive. They know they can bill Medicare and insurers by using codes for similar cardiac procedures to partially pay for atrial ablations. Doctors perform ablations in major hospitals or teaching centers, where doctors are on salary and not compensated for procedures, but who wish to distinguish and differentiate themselves from the competition. The American Heart Association and the American College of Cardiology have recommended the procedure, and many established and start-companies are marketing ablation devices. Major ablation centers are trumpeting ablation success stories and marketing services to atrial fibrillation victims..

When patients want something done, and doctors and hospitals want to do it, and mounting anecdotal evidence shows it works, it will be done, and there is little government can do to stop it.

Market forces often move so fast they overwhelm government assessment and resistance. There are limits to federal intervention in health care, and catheter-ablation to remove or neutralize the cause of atrial fibrillation is the latest, but not the last example of those limits.