Sotera Health Holdings LLC has finalized a $408 million settlement for litigation over the company’s use of ethylene oxide (EtO) at a Sterigenics facility in Willowbrook, Ill., although litigation is still pending in connection with sites in other U.S. states. The news comes as med-tech trade associations register their disappointment with an EPA proposed rule for EtO that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (Advamed) argue would crimp availability of sterilization capacity, which would in turn create shortages of medical devices and supplies that are desperately needed by patients.
The U.S. Office of Inspector General (OIG) has concluded an analysis that found fault with Medicare payments for genetic testing under CPT code 81408, a code that covers tests for a variety of mutations of medical interest. According to OIG, these claims were often paid $2,000 each despite poor oversight from Medicare administrative contractors (MACs), raising the risk that a substantial percentage of roughly $888 million in claims paid between 2018 and 2021 were either fraudulent or at best inappropriate.
U.S. Medicare coverage for breakthrough devices has been a hot topic for several years now, but industry is one step closer to making this policy dream a reality thanks to another new proposal from the Centers for Medicare & Medicaid Services (CMS). The agency released a new version of the Transitional Coverage for Emerging Technologies (TCET) program that seems to satisfy most of what med-tech trade associations sought, but the catch is that manufacturers must notify CMS of their intent to take part in TCET a year before the FDA will decide whether to grant market authorization to the device.
The U.S. FDA reported a pilot program for validation of lab-developed tests (LDTs) used as companion diagnostics, a move that seems an implicit recognition that test kits as CDx products are not the darlings of test developers. The program arrives as the agency is considering rulemaking for regulation of LDTs, however, a combination of developments that promises to roil the already strained relationship between the FDA and clinical labs.
The question of when U.S. federal attorneys can dismiss a whistleblower suit filed under the False Claims Act (FCA) has roiled the courts for several years, but the Supreme Court has laid many of those questions to rest in an 8-1 ruling which said that the government can dismiss a whistleblower FCA case only after federal attorneys have intervened.
The U.K. Medicine and Healthcare Products Regulatory Agency (MHRA) has moved to incorporate the Global Medical Device Nomenclature (GMDN) system into its device registration database, a development that will ease the task of providing postmarket surveillance for these products. However, the change may also take some of the noise out of the registration process in the U.K. market, thanks to the standardization of information the GMDN represents.
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
The U.S. Federal Trade Commission (FTC) reported a settlement with San Francisco-based 1Health.io Inc. for allegations that the consumer gene testing company failed to properly secure customers’ data, an oversight that will cost the company only $75,000 in fines.
Radiotherapy fractionation has had a significant impact on the morbidity associated with the procedure across a number of cancer types, and the U.K. National Institute for Health and Care Excellence (NICE) says it may be time to fractionate further for some breast cancer patients.
The Vanta device by Medtronic plc, provides relief from pain for thousands of patients, but the Vanta might also feel the pain when the patient is undergoing cardioversion. According to a field safety notice from Dublin-based Medtronic, two patients in Europe have undergone explant procedures for the device due to damage sustained during cardioversion, but the company urges physicians to pay heed to the labeled indication, which recommends that the device be temporarily reprogrammed to reduce the risk of damage to the device, an action that Medtronic indicated should ward off any such issues.
