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On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at the end of the program.
Globally, the convergence of software technology and life sciences creates a massive opportunity for growth, and the market for these products is growing exponentially. Both the U.S. Food and Drug Administration (FDA) and European regulators have focused on establishing a regulatory framework for oversight of SaMD.
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On March 17, 2021, CMS published an Interim Final Rule (86 Fed. Reg 14542) delaying the effective date and establishing a public comment period for the Final Rule for Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary. The Interim Final Rule delays the initial March 15, 2021 effective date for 60 days until May 15, 2021. The Interim Final Rule also provides a 30-day public comment period to allow interested parties to provide comments about issues of fact, law, and policy raised by the rule. CMS states that it would determine whether further actions are appropriate, which could include revising or rescinding the Final Rule. Comments are due by
Medicare Coverage Breakthrough Delayed | King & Spalding jdsupra.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from jdsupra.com Daily Mail and Mail on Sunday newspapers.
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CMS has postponed for 60 days the implementation of a final rule that would provide immediate Medicare reimbursement for devices authorized through FDA s breakthrough device program, saying it could revise, further delay or even rescind the proposed action after considering additional public input.
The announcement follows President Joe Biden s freeze on new regulations and comes just days after a group of physicians writing in the New England Journal of Medicine called for the pending breakthrough device coverage rule to be retracted. The government s notice notes that and other critiques of the rule.
AdvaMed has been a vocal proponent of the Medicare Coverage of Innovative Technology rule and has urged the Biden administration to implement and strengthen the initiative.
VisCardia Announces Issuance of American Medical Association CPT® Category III Codes for Synchronized Diaphragmatic Stimulation (SDS®)
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PORTLAND, Ore., March 16, 2021 /PRNewswire/ VisCardia Inc., a privately held medical device developer, announced today that the American Medical Association (AMA) has issued (ten) 10 new Current Procedural Terminology (CPT
®) Category III codes in support of the implant procedure and management of Synchronized Diaphragmatic Stimulation (SDS
®) therapy as provided through VisCardia s proprietary, implantable VisONE
® heart failure management system.
The CPT Category III codes for SDS will be effective Jan. 1, 2022, and provide the ability to track the VisONE implant and related procedures moving forward, including during VisCardia s anticipated US IDE study.