Letter to Andy Slavitt, Centers for Medicare & Medicaid Services Acting Administrator - Medical Innovation Regulations

Letter

Dear Administrator Slavitt,

We write to express our concern with ambiguity in the description of molecular pathology testing technologies in the Medicare Part B program. We have heard concerns about lack of clarity as to the inclusion of both RNA and DNA nucleic acid analysis in the Molecular Pathology section of the Healthcare Common Procedure Coding System (HCPCS) Level I / Current Procedural Terminology (CPT). As currently written, users of the HCPCS/CPT may be confused and conclude that RNA testing procedures are excluded except where specifically addressed.

When new and innovative technologies come to the market, we want to ensure that CMS is not acting as an obstacle by failing to make these updates. We ask that CMS update the HCPCS/CPT to clarify that nucleic acid testing includes both RNA and DNA. This action will harmonize the interpretation of the codes and enable the best technology (either DNA or RNA) to be used in the diagnostic test. If this is not an action that your agency can take, please entail in your replying correspondence reasoning behind your decision. Please provide a response to this inquiry and information on the status of this request by August 28, 2015.

We thank you for taking this request into consideration and look forward to working with you on this important matter.