August 07, 2014
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CMS approves add-on payments for MitraClip, CardioMEMS

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As part of the new technology add-on payment program, CMS has approved new reimbursement coverage for the MitraClip and CardioMEMS devices that will reduce health care costs for patients in need of these therapies.

According to a press release, the new technology add-on payment (NTAP) program is designed to help provide additional reimbursement and timely access to innovative technologies for Medicare beneficiaries.

The new coverage will take effect on October 1 of this year.

In October 2013, the first-in-class MitraClip received FDA approval for the treatment of patients with symptomatic mitral regurgitation. This was followed in May by a decision memo from CMS that proposed coverage for certain cases of transcatheter mitral valve repair with the device.

In an email response, Charles Simonton, MD, chief medical officer for Abbott Vascular, said the NTAP coverage for MitraClip “is an important step forward in improving access to the therapy … while more appropriate hospital reimbursement for MitraClip is established.”

For St. Jude Medical, the NTAP coverage follows just over 2 months after receiving FDA approval for its CardioMEMS HF System for measuring pulmonary artery pressure and heart rate in patients with NYHA class III HF who have been hospitalized for HF within the previous year.

“[The NTAP] decision helps ensure that Medicare patients have access to this innovative technology as we introduce CardioMEMS as a new treatment paradigm to proactively manage heart failure, improve patient outcomes and reduce hospital admissions,” Eric S. Fain, MD, group president of St. Jude Medical, said in a press release.

In related news, CMS also issued a National Coverage Determination (NCD) that extends coverage of the MitraClip for Medicare beneficiaries in the United States who are in need of transcatheter mitral valve repair. According to a press release, the NCD provides a national framework for Medicare coverage that can help patients gain more timely access to the MitraClip procedure if they meet the eligibility requirements.