Many health care facilities in the U.S. have deployed artificial intelligence (AI) algorithms that are tailored for the patient population seen in those clinical settings, a practice that avoids FDA regulation by removing the question of commercial distribution.
The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.
The controversy over the use of paclitaxel (PTX) in devices used to treat peripheral artery disease (PAD) has taken roughly half a decade to unwind as regulatory agencies across the globe stand down their restrictions on the use of these devices.
A U.K. national health service (NHS) hospital has begun offering Allurion Technologies Inc.’s swallowable gastric balloon to patients struggling to lose weight for surgery. The move is a boon for the company amid rising competition in the weight loss market from GLP-1 agonists.
The U.S. Congress has passed a continuing resolution (CR) for the fiscal 2024 budget, an exercise that has become all too common as a substitute for a full suite of spending bills in an era of growing deficits.
One of the more significant enforcement actions to date in 2024 is the $13 million hit taken by the owner of a clinical lab in New Jersey for allegations of payment of kickbacks for unnecessary testing, suggesting that this new year will be a robust one for federal fraud enforcement in the U.S.
U.S. physicians who provide radiation services for cancer patients have a long-running feud with the Centers for Medicare & Medicaid Services over a series of payment rate cuts for their services, but these medical societies are now teaming up to address the issue. These medical societies are making the case that payment reform is not only critical for the future of radiation oncology but are also optimistic that congressional interest in the dilemma has quickened sufficiently to suggest that a congressional response may be on tap in 2024.
Intravascular ultrasound is the preferred imaging modality for a number of procedures conducted on the circulatory system, including some procedures performed in the peripheral vasculature, but adoption is seen in some quarters as sub-optimal. A trio of medical journals have published a consensus statement pressing the case for more widespread utilization of IVUS for peripheral artery disease, but one of the sources of drag is poor Medicare reimbursement, a problem that might only be resolved in a piecemeal fashion.
Intravascular lithotripsy generally scores well for removal of calcification, but the U.K. National Institute for Health and Care Excellence (NICE) is offering only limited endorsement of this procedure for peripheral artery disease (PAD). NICE said one of the problems with the evidence is that this procedure is often conducted in conjunction with other procedures, and thus the agency will have to see more definitive evidence before an unequivocal endorsement is justified.
The med-tech industry had high hopes in 2023 regarding Medicare coverage for breakthrough medical devices, but those hopes were dashed when the U.S. Centers for Medicare & Medicaid Services (CMS) withdrew the associated draft rule and will instead issue a “notice” regarding the Transitional Coverage for Emerging Technologies (TCET) concept.
