NEW YORK (GenomeWeb) – Exact Sciences said on Wednesday that a Medicare panel has unanimously voted to keep the reimbursement rate for the firm's Cologuard test at $492.72.
The final tally on the vote by the Centers for Medicare and Medicaid Services Advisory Panel on Clinical Diagnostic Laboratory Tests was 11-0 with one abstention. The vote comes after Exact Sciences Chairman and CEO Kevin Conroy presented a proposal at a public meeting in July to crosswalk Cologuard from its current G code to a new CPT code that was created by the American Medical Association for the stool-based DNA colorectal screening test.
Conroy said last month that the new code was not expected to materially impact pricing for Cologuard but would improve efficiency around getting reimbursement for the test, as a G code often triggers a manual review and slows down the reimbursement process.
Conroy said on Wednesday that CMS will post a preliminary determination after considering the July meeting comments, the panel's vote, and other written comments. A final determination is anticipated around November and will take effect Jan. 1, 2016.
Cologuard was approved by the US Food and Drug Administration a year ago. Shortly afterward, CMS issued a final national coverage determination for the test.
"Although expected, the news is positive and removes an overhang for the stock," Mizuho Securities USA analyst Peter Lawson said in a note this morning. "We expect a positive final decision from CMS, which would make it easier to collect reimbursement and enhance uptake of Cologuard."
In Thursday morning trade on the Nasdaq, shares of Exact Sciences were up 5 percent at $22.11.