Letter to OHRP Criticizing the Agency’s Position Allowing CMS to Require Medicare Beneficiaries Undergoing Transthoracic Aortic Valve Replacement to Participate in Research

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In a letter to the Office for Human Research Protections, Public Citizen criticized the agency’s interpretation of the federal regulations for the protection of human subjects that allowed the Centers for Medicare and Medicaid Services to require Medicare patients to participate in research as a condition of coverage for transcatheter aortic valve replacement.

January 23, 2013, Department of Health and Human Services (DHS) response