MolDX: Coverage with Evidence Development

During a review of the clinical utility component of a MolDX Technical Assessment (TA), Palmetto GBA recognized the need to develop a mechanism to provide rapid patient access, while also generating the evidence necessary to assess benefits and risks for test(s)/service. Under this approved mechanism, also known as a Coverage with Evidence Development (CED), the MolDX Program may provide coverage for promising, but unproven diagnostic tests contingent on the submission of plans to conduct a clinical study that will generate additional evidence to support their safety, diagnostic performance, and most importantly, clinical utility. Although Palmetto GBA will consider a test-specific CED policy based on an adequate CED study plan submitted by the test developer, the MolDX Program does NOT include design or the performance of the study necessary to determine the clinical utility of the identified test/service.

MAC for Jurisdiction 11; comprised of North Carolina, South Carolina, Virginia and West Virginia; and MAC for Jurisdiction 1; comprised of California, Hawaii and Nevada.