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CMS Weighs Whether Volume Requirements Are Needed For TAVR

 
• By David Filmore

The US agency will convene advisors this summer to reassess whether hospital and practitioner procedure volume requirements, currently a prerequisite for running a Medicare-covered transcatheter aortic heart valve replacement program, are warranted.

When the national Medicare coverage policy was set for transcatheter aortic valve replacements (TAVR) in 2012, it specified a minimum number of heart-valve surgeries, percutaneous coronary interventions and other types of procedures that hospitals and physicians must have under their belts to maintain a TAVR program sanctioned by the public-payer program.

The baseline requirements were one key element that have driven product rollout strategies for Edwards Lifesciences Corp. and

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