New York Times Examines Refusal by Many Health Insurers To Cover New Medical Devices

The New York Times on Wednesday examined why some FDA-approved medical devices are not widely covered by health insurers. According to the Times, the "years and millions of dollars" that medical device makers invest to gain FDA approval do "not necessarily produce the kind of data that persuades insurers to pay for the products once they hit the market."

For example, Johnson & Johnson's Charité -- a spinal disk that can be implanted as an alternative to spinal fusion -- received FDA approval eight months ago, but most private insurers have chosen not to cover the $30,000 to $45,000 procedure. Medicare provides some coverage, but at a reimbursement level "far less" than the cost of the disk, the Times reports. Insurers -- including the government -- say more data is needed on the disk's durability and performance for various patient groups, particularly for young adults and middle-aged patients.

Similarly, many insurers have declined to cover a treatment from Guidant that can be an alternative to neck surgery and implanted heart rhythm management devices from Medtronic and other companies, the Times reports.

In the case of the spinal disk, Michael Chee -- a spokesperson for Blue Shield of California, which does not cover the procedure -- said, "Charité needs to show substantial improvement in the patients' quality of life and clinical outcomes."

However, critics say that insurers move slowly because they "profit from delaying decisions to cover new technology," the Times reports. John Peloza, a spine surgeon in Dallas, said, "Insurers don't really care about the science as long as the answer comes out that they don't have to pay for it" (Feder, New York Times, 7/6).