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Medicare to cover artificial heart in research studies

Device Regulation Alert: Safety, Compliance and Reimbursement News, February 11, 2008

Since 1986, Medicare has denied coverage for artificial hearts, but on February 1, it took a step back from that position. CMS proposed covering artificial heart devices under coverage with evidence development for Medicare beneficiaries participating in FDA-approved studies subject to several requirements.

Artificial hearts still are not considered reasonable and necessary under Medicare's coverage standards, but CMS acknowledged in the proposed decision memo that evidence demonstrates the potential use of artificial hearts and justifies further research.

According to the memo, eligible studies must address at least one of these three questions:

• What is the average time to device failure?
• What are the potential outcomes of using artificial hearts in larger numbers of patients?
• What unique circumstances or patient conditions affect outcomes?

The decision memo also lists 14 criteria that must be met for the study to qualify for coverage of the artificial heart. Among other things, the study must:

• Be an FDA approved study
• Be intended to determine if a particular "intervention" improves patient health
• Be supported by sufficient medical information or attempt to prove outcomes of existing interventions
• Not duplicate existing studies
• Comply with all federal regulations protecting human subjects
• Be sponsored by an organization or individual that can successfully conduct the study
• Involve patients who have life-threatening conditions and no other options
• Be registered on ClinicalTrials.gov before subjects are enrolled
• Have a protocol requiring public release of results reporting within specified time frames

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