The recent controversy over the use of laparoscopic power morcellators in the treatment of uterine fibroids, and the role of insurers in influencing those decisions, has taken another significant turn. America's Health Insurance Plans (AHIP) is calling for the insurance industry to impact the situation not only via influence on the medical community, but through efforts to improve the regulation of such devices.
The morcellator question
In a letter sent last week to Sen. Robert P. Casey that AHIP has provided to Healthcare Dive, association President and CEO Karen Ignagni outlines what the group deems "serious gaps in the current approval and post monitoring process for medical devices" and suggests how specific regulatory changes could improve patient safety. Casey had contacted the group March 24 to gauge the industry's position on morcellators.
The issue has illustrated the growing reach of the health insurance industry. While insurers may still face uphill battles in influencing change outside their traditional sphere of influence, their voices are clearly carrying weight.
AHIP's letter indicates that chief medical officers in the industry are seeing a major reduction in the use of laparoscopic power morcellators, and credits insurers among those responsible. "The action of the FDA, the comments by ACOG, and the steps taken by health plans have contributed to the decline in use of power morcellators," states AHIP's letter.
Is device regulation adequate?
AHIP is now criticizing the fact that most medical devices regulated by the FDA receive their market approval through the 510(k) process, in which the manufacturer only needs to demonstrate that their device is "substantially equivalent" to another one already approved and on the market. The manufacturer does not have to assess its specific medical device for safety and effectiveness.
"As Congress continues to explore ways to promote biomedical innovation, we urge discussion around strengthening the 510(k) process and post-marketing assessment of medical devices, including power morcellators," AHIP writes. They add that requiring post-marketing review will aid insurers' ability to identify adverse events and react quickly to other emerging safety issues.
Along with these efforts, AHIP is urging the acceleration of the unique device identification (UDI) system, which was signed into law with the Food and Drug Administration Amendments Act of 2007 but has not been given a timeline. AHIP notes that UDI integration into clinical data sources including EHRs is a key part of the goal toward a national medical device surveillance system, which it says numerous member health plans participated in developing. "Expanding UDI use would also complement the FDA's Safety Sentinel project in which our member plans have been integrally involved," the letter states.
Opposition viewpoints
AHIP's position is not without opposition. While the 510(k) system has been criticized by other groups, including a 2011 Institute of Medicine panel, others are defending it in the medical-device industry and the FDA.
Steve Ubl of the Advanced Medical Technology Association responded to AHIP's letter with comments in the Wall Street Journal, in which he calls the 510(k) system "overwhelmingly safe."
"FDA's 510(k) review process for low- and moderate-risk medical technologies has a proven safety record and allows the agency to conduct a thorough review of the safety and effectiveness of these products in a timely fashion that facilitates patient access to needed medical advancements," he told the Journal.
The FDA declined to comment on the letter.