Insurers raise questions about medical device approval process

A recent advisory notice issued by the U.S. Food and Drug Administration (FDA) on the risks of laparoscopic power morcellators is raising concerns about the regulation and approval process of medical devices.

In addition to industry concern, the Wall Street Journal reported in late May that the Federal Bureau of Investigation (FBI) is investigating whether providers and medical device makers broke the law by failing to report problems linked to morcellator use.

In November 2014, FDA issued a notice that laparoscopic power morcellators could spread previously undetected cancers in women undergoing hysterectomy for the treatment of fibroids. The notice followed growing questions about the safety of the devices voiced by the medical community and insurance industry.

Shortly after, United-Healthcare began requiring prior authorization for certain hysterectomy procedures.

Marc Sanchez, an attorney for Contract In-House Counsel and Consultants, LLC, a boutique law firm focused on FDA and U.S. Department of Agriculture regulation, says it is not surprising that health insurers are speaking up about device safety concerns. “When the risks that become associated with a device are so severe that it outweighs the benefits of using it, insurance companies know its use will lead to greater costs down the road,” he says. “Based on what we have seen for this particular device, that seems to be the case.”

NEXT: New regulations needed?

New regulations needed?

Among those questioning medical device regulation is America’s Health Insurance Plans (AHIP), which in April sent a letter to Sen. Robert P. Casey Jr., D-Pa.,  about gaps in the device safety infrastructure and the critical need to strengthen pre-and post-market review and approval.

“Currently, a majority of devices regulated by the FDA receive market approval through a less stringent device approval system known as the 510(k) process,” the letter stated. “Power morcellators received approval in this fashion, where the device manufacturer needed only to demonstrate that a device is ‘substantially equivalent’ to a device already on the market rather than conduct studies to assess the safety and effectiveness of that specific device.”

Noting that health plans “actively disseminate safety information to their clinicians as part of their ongoing efforts to provide access to safe, effective care,” the letter states that “Actions by regulatory agencies, professional medical society guidelines, and clinical peer-reviewed studies all play critical roles in influencing provider practice, patient treatment options, and insurance coverage decisions.”  When plans modify coverage policies about such issues, it opens up dialogue with physicians about alternative treatment options, says AHIP.

The association encouraged lawmakers to consider strengthening the 510(k) process and post-marketing assessment of medical devices. “Requiring post-marketing review will greatly improve our ability to identify adverse events and to act more rapidly when safety issues are identified. Had this been required for morcellators, safety issues would have been identified much sooner.”

It also called for acceleration of the unique device identification (UDI) system, which will enable providers to have key device information on hand at the point of care. It stated that UDI integration into clinical data sources, such as device-specific registries and electronic medical records, is a key part of developing a national medical device surveillance system.

NEXT: FDA guidance details

FDA guidance details

Deborah Kotz, FDA press officer, says that medical device safety is critical to protecting the public health, but there is a potential risk with any drug or medical device, “from aspirin to laparoscopic power morcellators.

“The FDA weighs the benefits and risks of every medical device we review. And, while mitigating risk helps protect public health, we must balance risk with the careful evaluation of patient benefit to help promote public health,” she says.

The morcellator advisory issued in November, says Kotz, asks the manufacturers of laparoscopic power morcellators to include safety statements in their device labeling that say that uterine tissue may contain unsuspected cancer and that patients should be informed of the risk of spreading cancer from the use of these devices during fibroid surgery.

“This was an immediate step to protect patients,” says Kotz. “The FDA will continue to consider other steps that may further help to reduce the risk of spreading unsuspected cancer--such as encouraging innovative ways to better detect uterine cancer and containing potentially cancerous tissue.”

NEXT: Expedited Approval

Expedited approval

Because of concerns about the approval process for medical devices including the morcellator, some healthcare professionals are questioning the FDA’s Expedited Access Pathway program, designed for devices that address serious or life-threatening conditions. However, Sanchez says he does not see the two ideas as being at odds.

“The new expedited approval process is the FDA’s answer to a public policy question that we are still debating, and that is, how do we balance safety and innovation?” says Sanchez. “There is a lot of criticism of the FDA in comparison to its counterpart in the (European Union) saying that the EU is much more rapid in responding and approving new innovative technologies and getting those to the EU public.”

He says the FDA has always taken the stance that the U.S. public should not be “guinea pigs” in an unapproved giant clinical trial. “There have been a lot of cases where we see a device that was approved in Europe that was not approved by the FDA and it does have post-market issues and ends up being recalled or having problems,” he says. The expedited approval process, says Sanchez, is a narrow opening to cover important unmet needs.

In the meantime, says Kotz,  the FDA continues to strengthen how it reviews devices, and is working on a national post-market surveillance strategy that is expected to bolster the amount and quality of information on medical devices once they are on the market.

Sanchez notes that an FDA task force is reviewing all aspects of the device approval process, including the ability to rescind approval if post-market issues arise. He calls this a positive step, especially considering the U.S. did not have medical device regulation until 1976. Few aspects of device regulation have changed since then, he adds.

“That’s a long time to have a particular mechanism in place when you think about how rapidly technology changes,” he says. 

Beth Thomas-Hertz is a writer in Columbia Station, Ohio.