Policy Change Provides Coverage, in Clinical Studies, of Artificial Hearts

On May 1st, the Centers for Medicare & Medicaid Services announced a change in policy which will benefit patients with severe heart failure.  The new policy allows Medicare to cover artificial heart devices when used as part of a FDA-approved study, as long as the study meets CMS’ clinical research criteria. 

Artificial heart devices are intended to help patients with critical heart failure.  In many cases, the device will help someone survive until a transplant heart becomes available.  They can also be used to prolong the lives of patients unable to receive a transplant. 

Although Medicare has not previously covered the use of this technology, research on the safety and success of artificial hearts has resulted in an important change of policy.  While CMS still does not believe evidence is conclusive on the necessity of the device, they have determined that it can potentially improve health outcomes and should be further researched. Therefore, under certain circumstances, people requiring the life-saving measures offered by artificial heart devices can receive the needed coverage. 

In order to receive coverage, the artificial heart must be implanted as part of a clinical study, approved by the FDA.  The study must be designed to answer one of three specific research questions and meet a number of criteria (available in detail at http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=211)

The new policy guidelines are intended to protect beneficiaries, since a clinical study will include safety, patient protection, monitoring, and expertise.   The guidelines are also, of course, designed to aid the continuing research on the outcomes of artificial heart technology.  Whatever the reasons or requirements involved in the policy change, it can only mean good news for those requiring an artificial heart. 

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