CMS Delays Pricing New Molecular Pathology Codes – Questions Remain for Local Contractors

At CMS’ “Laboratory Public Meeting on Payment for New Clinical Laboratory Tests for 2012,” held on July 18th, the agency officially acknowledged that it is delaying its decision as to whether to place the 101 new AMA CPT codes for genetic tests on the clinical laboratory fee schedule (CLFS) or the physician fee schedule (PFS) until next year. A CMS spokesperson explained that, by law, since the new genetic test codes were not discussed at this week’s public meeting they could not be priced on the CLFS for the 2012 fee schedule. While at a national level CMS is not putting these codes on the CLFS, they suggested that local contractors could make their own pricing decisions about the codes. However, subsequent discussion between the national level CMS spokespeople and a contractor did not entirely clarify what the process might be. After Monday’s annual meeting on payment, CMS held an “Information Session: Discussion on New Genetic Testing Codes,” in which they sought input on the CLFS vs. PFS question. Representatives from both the College of American Pathologists (CAP) and the Association for Molecular Pathology (AMP) argued for placing the new codes under the PFS, as they claimed that physician interpretation is required for the majority of these tests and the PFS allows for frequent updating, which is necessary for a fast moving area like genetic testing. The American Clinical Laboratory Association (ACLA) recommended that each new genetic code should be assessed individually to determine how the interpretive function is most commonly performedby a pathologist (put on PFS), a nonphysician (put on CLFS), or by advanced computer systems (put on CLFS). Meanwhile, multi-gene panel tests, such as OncotypeDx and Mammaprint, have not yet been addressed by these new codes or by Medicare at all. There is concern among developers of these tests that if they get placed on the PFS they could see their reimbursement levels drop.