Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
The U.S. Senate held a July 25 hearing on the need for regulation of artificial intelligence (AI), which highlighted an interest in a single overarching agency that would direct any regulations promulgated for AI across the U.S. economy.
Advocates are pressing the U.S. Congress to pass legislation to require more Medicare coverage of telehealth and telemedicine, but the Office of Inspector General (OIG) continues to report instances of fraud in this area. OIG reported July 24 that government attorneys had forced a guilty plea out of a telemedicine provider who has agreed to pay $44 million to deal with charges of fraud perpetrated over a period of three and a half years.
The U.S. Federal Trade Commission (FTC) has been exceptionally active in the mergers and acquisitions space for the past 18 months, but Congress might soon amplify these agencies’ ability to suppress these transactions. Sen. Amy Klobuchar (D-Minn.), who chairs the competition subcommittee of the Senate Judiciary Committee, said in a recent hearing that vertical mergers have flown largely off the enforcement radar, a problem that Congress could address by several means, including by providing the FTC with a heftier budget to pursue these cases.
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices.
Physicians and device manufacturers don’t always see things the same way, but there are large areas of overlap, such as the impact of prior authorization and the effects of certificates of need for radiology facilities. These two issues came up in a hearing of the House Small Business Committee, suggesting that legislation may be forthcoming that would tackle these and other issues that hamper both the practice of medicine and sales of medical devices.
Summer is the time when device makers press their cases for add-on and pass-through payments from the Medicare program, and this year’s draft hospital outpatient prospective payment system for calendar year 2024 is no exception. Both Cook Medical and Philips North America are pushing CMS for new technology pass-through (NTPT) payments for their offerings, but these two larger firms have a lot of company in the NTPT sweepstakes.
U.S. FDA warning letters to device makers seemed to be on pause for a couple of years, but the agency is picking up the pace with two warnings posted July 18. Outset Medical Inc., of San Jose, Calif., was previously known to be the recipient of a warning letter, but Edge Biologicals Inc. of Memphis, Tenn., took in a warning letter that is replete with repeat violations disclosed in 2015 and 2018, as well as a warning letter issued 11 years ago.
The U.S. Federal Trade Commission and the Department of Justice have floated a new set of guidelines that would govern their reviews of mergers in a variety of markets, including the drug and device industries. While many of these guidelines are vaguely worded and open to interpretation, one of the more ambiguously worded passages states that a merger may be rejected if it could create “a clog on competition,” a phrase that appears in a Supreme Court decision handed down more than 60 years ago.
Recalls are a fact of life in the medical technology space, and Medtronic plc and Quidel Cardiovascular Inc., have both been forced to report class I recalls. Dublin-based Medtronic announced a recall of more than 348,000 cardiac electrophysiology devices due to issues that could prevent high-voltage therapy while San Diego-based Quidel is recalling nearly 7,800 Triage cardiac panels because of a risk of false negatives for patients being assessed for an infarct.
