CardioMEMS system receives approval from CMS for New Technology Add-On Payment


St Jude Medical has announced that the Center for Medicare and Medicaid Services (CMS) has approved a New Technology Add-on Payment (NTAP) for the CardioMEMS heart failure system. The CardioMEMS heart failure system is the first and only US Food and Drug Administration approved heart failure monitoring device that has been proven to significantly reduce hospital admissions when used by physicians to manage heart failure. The NTAP programme, which recognises new technologies that provide substantial clinical improvement over already available therapies, is designed to support timely access to innovative technologies for Medicare beneficiaries.

“We are pleased CMS recognises the substantial clinical benefit provided by the CardioMEMS heart failure system,” says Eric S Fain, group president of St Jude Medical. “This favourable 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.”

Beginning 1 October, 2014, CMS will reimburse hospitals an incremental amount in addition to the Medicare Severity Diagnosis Related Group (MS-DRG) payment.

The CardioMEMS heart failure system allows clinicians to monitor pulmonary artery pressures in order to proactively manage medications and other treatment options while also providing an early indication of worsening heart failure. The CardioMEMS heart failure system is supported by strong clinical evidence, including data from the CHAMPION (“CardioMEMS heart sensor allows monitoring of pressure to improve outcomes in NYHA Class III patients”) trial published in The Lancet. The CHAMPION trial demonstrated a 37% reduction in heart failure hospitalisations during an average follow-up duration of 15 months.