High-Cost Heart Therapy Highlights Cost-Efficacy Debate
An experimental treatment for atrial fibrillation known as ablation "stands out as another potentially budget-straining medical commitment" for health care payers including the federal government, the New York Times reports. The procedure costs between $25,000 and $50,000.
Medicare and private insurers spend billions of dollars per year to treat atrial fibrillation -- which affects at least 2.2 million U.S. residents -- primarily on hospitalizations, tests and off-label prescription drugs.
Atrial ablation involves neutralizing portions of the heart muscle that are the sources of abnormal electrical pulses that set off irregular heart beats. The original atrial ablation procedure included the use of surgical tools, but most of the procedures now are minimally invasive and involve the burning or freezing of heart muscle. Because the procedure has not been approved by FDA, doctors either use experimental equipment or equipment that has been approved for other uses.
Doctors and hospitals can bill Medicare or private insurers using codes for "somewhat similar" procedures, but they say the reimbursements "usually fall far short of full compensation for atrial ablation, which can take four hours or more to perform and requires an overnight stay at the hospital," the Times reports.
As a result, the procedures usually are performed at teaching hospitals and other centers where doctors are paid a salary, as well as by some specialty practices.
Advocates for the procedure say that it is more cost-effective over the long run than prescription drugs and improves patient outcomes, but some regulators and doctors say that clinical trials examining the procedure were poorly designed, that the "cure" rate touted by supporters possibly is being exaggerated and that the risks are being minimized.
Full-scale clinical trials have not yet demonstrated long-term benefits of minimally invasive atrial ablation, although less-rigorous studies have produced promising results.
Daniel Schultz, head of FDA's Center for Devices and Radiological Health, said, "This is one of those areas where the practice of medicine has moved faster than the approval process," adding, "This is very high on our list of areas that need concerted attention." Schultz said that FDA soon will schedule a public meeting to discuss drugs and devices that are used off-label as treatments for atrial fibrillation.
Carolyn Clancy, director of the Agency for Healthcare Research and Quality, said that any situation where off-label therapies become widespread "spotlights where we lack good evidence of which patients can benefit from which therapies." Clancy said that gathering information on atrial fibrillation is particularly challenging because the severity of the condition varies greatly among patients, most of whom also have other conditions that affect the risks and benefits of competing procedures.
The American Heart Association, the American College of Cardiology and four other major U.S. and European doctors' groups last month recommended that atrial ablation become the standard treatment for patients who do not respond to drugs (Feder , New York Times, 7/7).
The Times on Saturday also examined how doctors once viewed atrial fibrillation as "relatively benign" but have come to recognize that the condition "allows blood to pool in the atria and form clots, which in turn may explain why such patients are prone to strokes and heart attacks" (Feder , New York Times, 7/7).
Another Times article profiles the history of treatments for atrial fibrillation (Feder , New York Times, 7/7). The Times also published FAQ about the condition (New York Times, 7/7).