Medicare coverage of FDA-designated breakthrough devices is still a policy hot topic. Although the House of Representatives generated some momentum on related legislation, the Senate is now examining the Ensuring Patient Access to Critical Breakthrough Products Act for potential passage in the lame duck session – a development that would draw enthusiastic cheers from industry.
The FDA’s August 2024 draft guidance for predetermined change control plans (PCCPs) for all device types has provoked some misgivings among industry, with both the Medical Device Manufacturers Association and the Advanced Medical Technology Association blasting the draft’s limitations on the scope of the changes that could be included in a PCCP.
The FDA announced a new pilot program for communication of medical device recalls, but industry may be wary of a program that seems to be driven toward early notification of what the agency believes “are likely to be high-risk recalls.” The agency’s device center states that this latest effort is designed to “improve the timeliness of communications” of corrective actions undertaken by device manufacturers. This would apply when the corrective action is as significant as a device removal and when the corrective action constitutes nothing more than an update to a product’s instructions for use.
The health care potential for generative artificial intelligence comes with hazards such as the inadvertent effects of poor prompt engineering practices, but Anil Bhatta of Deloitte Consulting told a U.S. FDA advisory committee that this risk could be managed by rules that would thwart any consequent problems, such as an inadvertent jailbreak of the algorithm’s intended use.
The first day of the U.S. FDA’s two-day advisory hearing on generative artificial intelligence reflected some of the anxieties attached to this emerging technology, with the phenomenon of hallucinations driving several calls for more stringent regulation of this class of products that might be applied toward other entries in the class of artificial intelligence.
Makers of devices and diagnostics face a new set of policy questions following the 2024 U.S. general elections, but many of the impending changes at the executive branch seem directed more toward drugs and vaccines, seemingly leaving the device and diagnostics industries largely out of harm’s way.
Eko Health Inc. recently won a category III CPT code for its Sensora platform for cardiovascular disease detection. While a “cat III” CPT code hasn’t traditionally excited industry, the company is convinced that payers will respond because of the massive costs associated with cardiovascular disease.
Device makers are not necessarily fond of the need to acquire Medicare coverage by picking off one Medicare administrative contractor at a time, but Cleerly Labs Inc. worked this path with gusto.
The U.S. FDA’s Nov. 1 warning letter to Owens & Minor Inc. criticized the company for a lack of documentation that two components of convenience kits had been validated for sterilization with ethylene oxide.
