Kelly Slone

by & filed under Issues, Medical Innovation, NVCA Blog.

I’m excited to announce that President Obama signed into law on April 1 the “Protecting Access to Medicare Act of 2014,” modernizing the Medicare payment system for clinical lab tests with a market-based payment system.  This is an issue that NVCA’s Medical Industry Group has been working on collectively with other stakeholders for several years, and the reforms implemented into law track very closely to what NVCA proposed to Congress in 2008

In summary, the new law creates a new class of Advanced Diagnostic Laboratory Tests defined as sole source multi-analyte tests with a unique algorithm yielding a single result or a test that is cleared or approved by the FDA.  Beginning in 2017, new Advanced Diagnostics introduced to the market will be paid at the actual list charge for three quarters before transitioning to the market-based payment system.  Additionally, Advanced Diagnostics are eligible for temporary and unique permanent coding, which will take effect prior to January 1, 2016.

The new law also requires coverage policy for clinical diagnostics to be established through local contractor determinations (LCD) and directs the Centers for Medicare and Medicaid Services (CMS) to consider designating one or more Medicare Administrative Contractors (MACs) to establish coverage policies and process claims for clinical diagnostic laboratory tests.

Click here for a detailed summary of the new law from our friends at Foley Hoag LLP.