Dive Brief:

• Medicare's Coverage Analysis Group is likely in the second half of the year to weigh broadening the national coverage determination for mitral valve repair, Cowen Washington Research Group analysts predicted Monday in a note to clients.
• For mitral valve repair, Medicare could initiate either an NCD or a meeting of the Medicare Evidence Development and Coverage Advisory Committee.  
• A tracking sheet that would indicate CMS is formally considering changes to the NCD has not yet been issued.

Dive Insight:

Since CMS finalized its NCD on transcatheter mitral valve repair in 2014, Abbott has received an expanded indication for its MitraClip device to treat secondary mitral valve regurgitation. Abbott's MitraClip was first approved in the United States to treat primary mitral regurgitation, a condition associated with the structure of the mitral valve, in 2013.

Abbott said it would pursue a revision to Medicare's NCD at the time it received an expanded indication for MitraClip in March. In secondary mitral regurgitation, the heart becomes enlarged, preventing the mitral valve leaflets from closing properly. The catheter-based device clips together the valve's leaflets to reduce the backflow of blood, enabling the heart to pump more efficiently. The physician delivers the device to the heart through a small incision in the leg.

MitraClip's approval for secondary mitral regurgitation could double or triple the U.S. patient population eligible for the device, the Cowen analysts said in their research report. While MitraClip's primary degenerative indication addresses 60,000 to 70,000 U.S. patients, the secondary indication would add another 60,000 to 140,000 patients, they estimated.

Abbott is alone on the U.S. market with this type of device. Competition is coming, but the Cowen analysts do not expect it to arrive for another three years. Abbott recently sued Edwards Lifesciences in Europe for patent infringement, arguing that Edwards' Pascal device leverages MitraClip's design. Edwards received CE mark approval for Pascal in February and is fighting the lawsuit.

CMS has been busy in the heart valve space this year, having proposed changes to its coverage of transcathether aortic valve replacement (TAVR) in March. The draft policy retains volume-based restrictions on which hospitals can perform TAVR but would give providers more flexibility in meeting the criteria.