The reimbursement landscape for molecular testing has changed significantly since 2012. In January 2013 the historical code-stacking system was retired for Molecular Pathology (MoPath) codes that elucidate the analytes being tested. The rational for the new codes was to provide clarity on tests being performed enabling payers to make appropriate coverage and payment decisions, a feature lacking with the previous code-stacking system. In an effort to price the MoPath codes, ~100 codes were simultaneously priced through the gapfill process managed by local Medicare Administrative Contractors (MACs). In May 2013, the Centers for Medicare and Medicaid Services (CMS) published a compilation of MAC-proposed gapfill rates for public comment. If implemented, these rates would result in 20–75% reduction in reimbursement for key molecular tests, including inherited disease, molecular cytogenetics, and cancer testing. For example, EGFR testing was reduced from an average price of $650 per sample to $150, barely covering the cost of consumables for simple PCR-based tests.
Labs have the opportunity to respond to the proposed gapfill rates through July 8 and comments have been forth coming. Specialty societies, including the Association for Molecular Pathology (AMP) and the American College for Medical Genetics (ACMG), are banding together with laboratories to raise concerns to CMS that the inadequate rates may lead to reduced access to patient testing as labs are forced to reconsider far from profitable tests in their portfolio. AMP issued an email request to their members requesting fully burdened cost data for key undervalued tests, including cancer markers (EGFR, KRAS, BRAF, and BCR-ABL), molecular cytogenomic tests, and FMR1. ACMG is requesting fully burdened costing for inherited disease tests, including CFTR, molecular cytogenetics, FMR1, STR analysis, chimerism testing, long QT syndrome, and Prader-Willi/ Angleman syndrome through an online survey.
To help laboratories and hospital administrators respond in this critical time, Illumina provided the molecular testing community with educational information and advocacy tools. With assistance from Quorum Consulting, Illumina delivered a webinar series on the topic of MoPath Code implementation, the latest of which is now available for download. New web content offers labs guidelines and tools for responding directly to CMS or joining forces with specialty societies to provide cost data in aggregate. The time is now for labs performing molecular tests to respond to CMS with a plea for more favorable rates to enable sustainable patient access to tests.
Looking to the future, AMP proposed a new coding framework to CMS in March for testing using next-generation sequencing. Slated for implementation by the end of 2015, this coding system is meant to serve as a framework for payers to use when evaluating and reimbursing genomics-based testing, including reimbursement for interpretive analysis that may occur later in time or at another facility. In the meantime, it is crucial for existing MoPath codes to be sustainably priced as these codes are likely to be used as a precedence for pricing of other molecular tests, including next-generation sequencing. Learn what you can do to help at http://www.illumina.com/clinical/diagnostics/reimbursement/advocacy.ilmn.