The Cleveland Clinic Foundation (CCF) has found itself on the wrong end of an enforcement action by a federal attorney’s office, which had alleged that CCF had made false statements to the government regarding three grant awards.
A renewed focus on telehealth and telemedicine may be pumping new life into remote patient monitoring for heart failure, which seems to be the case for the Cardiomems device by Abbott Inc.
Ultrasound cyclodestruction may not be the darling of American ophthalmologists and their patients dealing with glaucoma, but that may soon change thanks to a recent move by the U.S. FDA. The agency has down-classified these devices from class III to class II in a move that may prompt competition for current device-based methods of treating glaucoma, including widely used laser-based treatments.
U.S. Medicare coverage of transcatheter aortic valve replacement devices requires the use of team medicine for patient selection purposes, which seems to have served as a tripwire for Cape Cod Hospital (CCH) in Hyannis, Mass. Federal agencies forged an agreement with CCH that included a $24 million fine for failure to appropriately screen patients for the procedure, an event that serves as a reminder that non-compliance with Medicare rules can trigger enforcement actions by other agencies.
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.
The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing device and drug shortages, although some of the drivers of these shortages are not within these agencies’ purview.
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.
The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing device and drug shortages, although some of the drivers of these shortages are not within these agencies’ purview. The FDA’s Jacqueline Corrigan-Curay told an audience here in Washington that the poor payment rates offered by payers for generic drugs are a significant contributor, adding that there are instances in which the per-dose rate paid for one of these generics is less than the typical charge for a cup of coffee.
Artificial intelligence recently roiled the regulatory world, but the U.S. Congress has yet to dive into the task of legislating on the concept. Barrett Tenbarge, general counsel for Sen. Bill Cassidy (R-La.) told an audience here in the nation’s capital that while the Senate is considering several legislative proposals, the desire to avoid legislation that will create as many problems as it solves suggest that legislative development “is a long-term process.”
The U.S. FDA’s final rule for regulation of lab-developed tests promises to remain controversial for the foreseeable future, but FDA commissioner Robert Califf said that many of these tests have been shown to be less than adequately reliable. Califf said that one of the effects of the final rule is that it will force clinical labs to “wake up and develop better tests,” if only because compliance and enforcement regimes will soon be applied to clinical labs.
