Regulatory, Legal, Coding, Billing, Reimbursement, and Ethical Considerations for Molecular Diagnostic Testing in Dermatology and Dermatopathology

Abstract

Molecular diagnostics is one of the most rapidly growing areas in laboratory medicine. Current applications in dermatology and dermatopathology cover a wide range of conditions, from infectious and inflammatory diseases, to cancer, and inherited skin disorders (genodermatoses). Early molecular tests were developed for diagnosis of systemic hematologic conditions, largely due to the relative ease in accessing specimens (i.e., venapuncture), possibility of abundant tissue for analysis (i.e., whole lymph nodes), and the capabilities of molecular methodologies available at that time (i.e., Southern blot analysis). Technical advances have now permitted the extraction and analysis of template (i.e., DNA and RNA) from both smaller and routinely processed (i.e., ­formalin-fixed ­paraffin-embedded [FFPE]) specimens (i.e., skin biopsies), enabling the application of molecular diagnostic testing to other fields, including dermatology. For example, diagnostic and follow-up evaluation of cutaneous diseases with sparse cellular infiltrates (such as many cutaneous lymphoproliferative disorders) is now possible. With the advent of methods for both target and signal amplification of nucleic acids, infectious disease testing has now become the dominant area in molecular diagnostics.