The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Rep. Payne resurrects colorectal cancer screening bill; Former Practice Fusion employee enters guilty plea; NICE says Alpha-Stim not ready for anxiety disorder.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neovasc snares second patent term extension; CMS drops CT image quality proposal; TGA opens docket for nanomaterials regulation; ATA supports OIG statement on telehealth.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MHRA lists premarket requirements; OIG says up-coding may be driving more expensive admissions; TGA tees up Haimex; White House calls for 100-day review for supply chain.
The U.S. Centers for Medicare & Medicaid Services (CMS) has determined that the time has come to offer Medicare coverage for blood-based in vitro diagnostics as a screening tool for colorectal cancer (CRC), but there’s one catch: At present, there is no such test approved by the FDA that qualifies under the terms of the coverage memo, making this a null coverage proposition, at least for the time being.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: White House names pick for CMS administrator’s post; FDA posts advisory for pulse oximetry; CDC: Telehealth visits dropped over last half of 2020; CRS says user fee shares of total review costs on the rise; Federal Circuit kicks case back to PTAB.
The expansions of coverage of telehealth associated with the COVID-19 pandemic will persist after the pandemic is over, even if the post-pandemic utilization does not match the current rates and types of utilization. However, speakers on a recent webinar hosted by Moses & Singer LLP of New York said that state medical licensure practices after the pandemic could be a help or a hindrance to more widespread use of telehealth, an issue stakeholders will want to track as 2021 unwinds.
The U.S. Centers for Medicare & Medicaid Services (CMS) had packaged a proposal to redefine the term “reasonable and necessary” along with the proposal to cover FDA-designated breakthrough devices, but ultimately punted on the definitional question until the end of this year. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that it may be just as well that the agency didn’t expeditiously push through the reasonable and necessary question because of the enormous complexity of the proposal.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Epigenomics out in Medicare NCD for CRC screening; TGA tweaks registration process for class I goods; Global initiative to take on Alzheimer’s; More on EMA cyberattack.
The impetus to provide more Medicare coverage of telehealth may prove irresistible, but the Medicare Payment Advisory Commission (MedPAC) has some reservations, including that telehealth payment rates should not favor companies like Dallas-based Teladoc Health Inc. over bricks-and-mortar clinics. This and other considerations are driving the commission toward a recommendation that a two-year telehealth pilot program would be more appropriate than simply jumping into a quickly broadened world of Medicare telehealth coverage.
The U.S. Centers for Medicare & Medicaid Services (CMS) issued a final version of a proposed rewrite of the national coverage determination (NCD) for mitral valve repair devices that includes a coverage with evidence development (CED) mandate. The final also retains the draft’s provisions for secondary mitral valve regurgitation, which analysts say will double or even triple the market for devices thus approved by the FDA.
RSS
