The Reimbursement Landscape for Novel Diagnostics: Current Limitations.

• A continuum of niche, moderate, and broad reform solutions offer different levels of beneficial impact and feasibility of execution.
  • Niche solutions address specific issues in the short- to mid-term. Examples include establishing a set of complex analytics codes, a system of test-specific codes, and a set of economic study standards for novel diagnostics.
  • Moderate solutions impact multiple issues in the mid-term. Some examples involve facilitating diagnostic coverage with evidence development and/or risk-sharing payment schemes.
  • Broad reform solutions require significant time and resources but provide the most impact, such as the establishment of a single coverage and value assessment body for novel diagnostics.
  • No individual reform measure can positively impact the entire system. A multi-solution approach to the current system’s limitations can provide short-term benefits while building towards broader diagnostic reimbursement reform.

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