Thursday, January 20, 2005
The Centers for Medicare and Medicaid Services announced yesterday that it will expand its coverage for surgically implanted heart-shocking devices for people with weakened hearts. The devices, called implantable cardioverter-defibrillators (ICDs) sense heart rhythm abnormalities and deliver shocks to the heart when potentially fatal flutters occur.
The Medicare decision is significant not only for its cost (estimated at more than $3 billion a year), but also because it demonstrates the government's willingness to use Medicare as a way to learn more about what works and what does not in medicine. Officials report that to receive ICD coverage, Medicare requires that the patient permit the collection of ongoing information about his/her health. The government plans to use such research to determine who best responds to the ICDs.
The Washington Post reports that, "The plan is part of an evolving federal effort to prevent a replay of recent events in which physicians and patients were surprised to learn that some popular anti-inflammatory drugs and antidepressants have more side effects than previously recognized. Given the huge numbers of patients who receive drugs and medical devices through Medicare, officials said, long-term data collection by the program can be a powerful complement to the modest follow-up efforts made by manufacturers and the Food and Drug Administration."
The coverage decision coincides withthe publication, in the New England Journal of Medicine, of results from a major study of ICDs sponsored by the National Institutes of Health.
It should be interesting to follow what happens with this decision. Monitoring of the program will be required to ensure that patient participation in more than data collection research is not made a condition of receiving medical care. In addition, I have heard from one cardiologist that some patients who have received a ICD shock have asked to have the ICD removed because, even though it saved their life, they have no wish to experience the shock again and would prefer to take their chances. So, I wonder if Medicare will cover removal costs as well. [bm]