Medicare Plans to Remove Mandatory Data Submissions for Implanted Heart Devices


The Medicare agency is proposing changes, including ending “burdensome” data requirements, for implantable heart devices for the first time in over a dozen years.

The Centers for Medicare & Medicaid Services announced last week it was seeking to update coverage decisions for implantable cardioverter defibrillators (ICDs), including eliminating some waiting periods and requiring patient-doctor decision making for some patients. The proposal would be the only major update to Medicare’s ICD coverage since 2005, and hospitals and device groups say an update is long overdue.

ICDs are battery-powered devices that treat abnormally fast, life-threatening heart rhythms by delivering a shock to the heart, restoring the heart’s normal rhythm and preventing cardiac arrest. The devices come with a heavy price tag, costing an average of $30,000 per device according to Medtronic. In order to receive Medicare reimbursement for ICDs, providers currently must submit data sets to the CMS that provide more information about the safety and effectiveness of the device.

The coverage determination data requests were intended to ascertain whether ICDs were safe and necessary enough to perform in clinical settings. Industry groups and hospitals have said the evidence and data the CMS has collected for the past 12 years have supported clinical use of ICDs.

Chandra Branham, vice president of payment and health-care delivery policy at the Advanced Medical Technology Association, told Bloomberg Law the group is still reviewing the proposal but upon first glance it supports the removal of the data collection requirement.

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