JudyORourkeI suppose it’s this way with most things in life; major advances are made and the status quo is disrupted as we figure out how to adopt them.

We hope for consensus on our collective aim to improve patient outcomes, and strive to move forward without having to take too many steps back in the process.

Good bye 2012…

The first at-home HIV test

Clinical next generation sequencing tests in pediatrics to help diagnose certain diseases

Advances in direct-to-consumer genetic testing


Hello 2013…

FDA guidance on lab-developed tests?

FDA guidance on direct-to-consumer genetic testing?

As I’m writing (December 2012), the sequestration issue has not been resolved. Will clinical labs be taking a 2% cut in reimbursement? Will clinical lab Medicare payments be hit with another 2% cut as fallout from tax cut measures? Will we be facing other potential lab cuts, such as cutbacks in the lab fee schedule, enactment of competitive bidding, and more?

A recent, key decision by the Centers for Medicare and Medicaid Services (CMS) substantially updates coding methods for molecular diagnostic testing—and affects all labs that perform these tests, which are blazing the personalized medicine trail.

As of January 1, 2013, all genetic and molecular CPT codes will receive payment based on the Clinical Laboratory Fee Schedule (CLFS) via the gapfill method, which supercedes the former stacking codes. Instead of billing CMS for each step entailed in molecular testing (stacking codes), labs will use molecular diagnostic codes that relate to particular analytes.

CMS has also defined a new group of Multivariate Analyses with Algorithmic Assays (MAAAs), which comprises tests that use an algorithm to analyze a group of individual analytes to devise an index score that predicts a clinical outcome.

The final payment rate is a work in progress. Medicare contractors will determine reimbursement costs in 2013 by adopting local pricing patterns. CMS will then evaluate regional reimbursement determinations before establishing a final national reimbursement rate that would take effect in 2014. The agency’s task of spelling out new, uniform rates in 2014 will no doubt be much easier than labs’ imminent mandate to gapfill dozens of codes without guidelines on a hard deadline.

Judy O’Rourke
Editor, CLP
[email protected], (619) 659-1065