Insurers want better FDA rules on medical devices

Health insurers are making their voices heard when it comes to approving and tracking medical devices.

America's Health Insurance Plans sent a letter to Sen. Bob Casey (D-Pa.) this week warning about the danger of premature FDA approval for devices and lax oversight after they hit the market, according to the Wall Street Journal, which reviewed the letter.

The letter cited regulatory gaps exposed last year when the tool used in hysterectomies, the laparoscopic power morcellator, was later found to spread cancer.

Casey wrote to AHIP on March 24 to follow up on the Food and Drug Administration's (FDA) announcement in November that advised restricting the tool in hysterectomies. Casey said he wanted to hear the insurance industry's reaction to the announcement and asked whether health plans track adverse events related to the device, reported the WSJ.

In the letter to Casey, AHIP President Karen Ignagni wrote that chief medical officers reported "a major reduction in the use of laparoscopic power morcellators in today's market." She also mentioned that tools such as morcellators aren't normally included in medical claims data, so it's difficult for insurers to know when they are used.

AHIP wants to improve the 510(k) system--the process the FDA uses to approve most medical devices--and efforts to track devices after they're approved. Identifiers would allow insurers to track the use of certain devices.

Insurers efforts to limit certain types of medical procedures isn't new. Recently, UnitedHealth began to require doctors get prior authorization before performing most inpatient hysterectomies. Anthem also requires it, while Aetna and Cigna do not, FierceHealthPayer previously reported.  

For more:
- here's the WSJ article