FDAnews Device Daily Bulletin

PROPOSED CHANGES TO CMS' REIMBURSEMENT FOR CARDIAC DEVICES 'PREMATURE,' SAYS HRS

June 7, 2006
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Changes to Medicare reimbursement rules proposed by the Centers for Medicare & Medicaid (CMS) will compromise treatments for a range of serious heart conditions, the Heart Rhythm Society (HRS) has announced.

It is "premature" to adopt the CMS proposal, the HRS said. "Patients and providers need a stable and predictable payment system, not one with such volatility and large swings in payments."

The HRS is primarily concerned about the impact the CMS' proposed new hospital inpatient payment system and FY 2007 rates would have on patient access to heart rhythm procedures to treat conditions such as atrial fibrillation, which the group says places nearly 2.2 million Americans at increased risk for heart disease and stroke.

These proposed reductions will "ultimately be translated into reduced patient access" to technologies such as implantable cardioverter defibrillators (ICDs) that prevent sudden cardiac arrest and cardiac ablations, "which are 90 percent effective in treating debilitating and life threatening cardiac arrhythmias," said Dwight Reynolds, HRS president. "Despite this convincing evidence" of the effectiveness of such devices, CMS' methodology would lead to severe payment decreases for ICDs, pacemakers and ablations, Reynolds said.