Case Studies

 

Advanced Diagnostics Laboratories Get Clarity on Medicare Coverage

Mapping the human genome has enabled revolutionary advances in understanding a wide variety of diseases, and ushered in an era where treatments can be tailored to individual patients based on their DNA and specific molecular character of their disease.  Complex diagnostic laboratory tests make such “personalized medicine” possible.  Government support for scientific exploration has propelled much of this development, but government payment and regulatory programs often work at cross-purposes.  Medicare, for example, has long struggled with how and whether to cover and pay for Multianalyte Assays with Algorithmic Analyses. When Medicare initially proposed to not cover these tests, many of the nation’s leading developers and financial backers of advanced laboratory diagnostics looked to our team to educate the Medicare agency.  At the end of the review process, CMS finalized a policy that maintains current coverage and payments saving these diagnostic developers millions of dollars.