HRS Submits Public Comments on ICD Coverage Policy

Updated on December 20, 2017

On December 20 2017, HRS and the American College of Cardiology (ACC) submitted a joint comment letter on the Medicare Proposed ICD Coverage Policy . The draft policy ends the data collection requirement and proposes to require a shared decision making (SDM) interaction prior to ICD implantation for certain patients.

The Societies support CMS’ efforts to facilitate patients’ understanding of their individual risk of sudden cardiac death and the potential benefits and risks of receiving an ICD. However, the Societies stress that a mandate for a formal shared decision making interaction with a decision tool is unnecessary.

 

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On June 29 2017, the Heart Rhythm Society (HRS) and the American College of Cardiology (ACC) submitted public comments on the revised CMS ICD coverage policy. HRS and ACC, with the help of our members’ expertise, provided information regarding the clinical evidence released since the policy was last updated in 2005.

NCD Comment Letter 637.07 kB
 

HRS and ACC will submit additional comments in November 2017 when CMS releases the draft ICD policy. CMS is expected to release its final decision regarding the payment policy by February 20, 2018.

In 1986, the Centers for Medicare and Medicaid Services (CMS) first issued a National Coverage Decision providing limited coverage of automatic implantable cardioverter-defibrillators (ICDs) through a process called Coverage with Evidence Development (CED) and the policy has broadened over the years with the growing clinical evidence. CMS last reconsidered the NCD in 2005 and as part of that reconsideration, mandated that hospitals participate in a national registry to address areas of uncertainty regarding the use and effectiveness of ICDs in routine clinical practice.

On May 30, 2017, CMS announced a 30-day public comment period to reconsider conditions of coverage for ICDs. The comment letter we submitted recommends that CMS reevaluate the CED requirement for study or registry participation as a condition of coverage. CMS will review the information submitted during this comment period to ascertain whether the level of required evidence has been attained, and will issue a proposed decision by November 30, 2017.

HRS welcomes this much-awaited opportunity to update the Medicare coverage policy to reflect current evidence and best clinical practice. HRS will address this policy update directly and will keep our community of heart rhythm professionals informed of our progress.