Palmetto Issues New Codes For BRCA, “Hotspot” Testing

Medicare fiscal intermediary Palmetto GBA quietly released new payment guidelines last month for several molecular tests under its MolDx program.

Palmetto issued new codes related to BRCA testing, tied to 146 specific genes. It approved 26 CPT codes for 40 separate BRCA tests for what it called "limited payment." They include tests being performed by Roche, Veracyte, CardioDX and other well-known labs. It assigned the same code, 81162, for tests being performed by Ambry Genetics, LabCorp, Myriad Genetics and Quest Diagnostics. The effective date for the Myriad test was in 2006, while the others had an effective date in 2014. That reflects the rise of competition for BRCA testing services after a 2013 U.S. Supreme Court decision that a patent could not be held on a single gene, invalidating the patent and monopoly Myriad had on BRCA testing.

Ten other labs were also assigned the unlisted CPT code 81479. They include Foundation Medicine's Foundation One test, Agendia's MammaPrint, and variants on the BRCA test offered by LabCorp and Myriad. Altogether, Myriad has been assigned five different codes for its BRCA variants. The assignment of so many codes at once may help mute some of the grumbling from molecular labs that the MolDX program has been slow to create straightforward payment pathways for their tests.

Another significant change by Palmetto was a determination that so-called next-generation sequencing "hotspot" tumor panels (between five and 50 genes being assayed) should be billed differently than sequencing panels, which include more than 50 genes. Palmetto issued three new codes for testing: 81445 (for a solid tumor of five to 50 genes); 81450 for the same testing for hematologic tumors, and 81455 for any tumor assay involving more than 50 genes.

"This may be a relief to some labs, because two of these codes were given very low list prices by CMS through the 2015 gapfill method," wrote Bruce Quinn, M.D., a senior director at FaegreBD Consulting, on his blog. Those codes, 81445 and 81450, will begin paying at around $700 apiece beginning on Jan. 1 of this year.

Palmetto also issued a hotspot code for BRCA testing, 88145. That was assigned to just one assay, the CANCER26 test performed by the Medical University of South Carolina.

However, Palmetto has still left unresolved billing for comprehensive genomic profiles (CGPs). "Because CGP includes SNVs, small and large insertions and deletions, CNVs, and rearrangements, CPT codes 81445, 81450, and 81455 do NOT describe a CGP service," Palmetto posted on its website. "Therefore, to report a CGP service, test providers should use CPT code 81479 - Unlisted molecular pathology procedure."

Takeaway: Palmetto has issued a large number of molecular testing codes that become effective in the new year.