On November 25, 2014, the U.S. Centers for Medicare & Medicaid Services (CMS) released its final determinations regarding the method for determining 2015 payment rates for new procedure codes under the Medicare Clinical Laboratory Fee Schedule (CLFS). CMS left its preliminary determinations unchanged after a lengthy review of stakeholder comments.
Highlights of the final determinations include deferral of a decision to price a series of new codes describing drug testing; continuation of “gap-filling” for Multi-Analyte Assays with Algorithmic Analysis and Molecular Pathology codes, including genomic sequencing procedures (commonly referred to as next generation sequencing); and a preliminary pricing decision for a new colorectal cancer screening test, coverage for which was finalized on October 9th, the same day that the preliminary determinations were released.
These final determinations will go into effect for services performed on or after January 1, 2015. However, in the 2008 Physician Fee Schedule Final Rule, CMS established a process whereby it would accept public requests for reconsideration of its final pricing decisions that will affect pricing for the subsequent year (i.e., 2016). CMS will continue to follow this process, despite the delay in the release of the 2015 final rates. Stakeholders will have 60 days to request formal reconsideration of pricing decisions. CMS will include a discussion of any reconsideration requests in the July 2015 public meeting.
In addition, under the Protecting Access to Medicare Act of 2014, payment rates under the CLFS will be subject to triennial adjustment (or for advanced diagnostic laboratory tests, annual adjustment) beginning with CY2017 based upon laboratory reporting of private payer payment rates for tests. Therefore, the annual preliminary and final determinations for new or substantially revised codes under the CLFS will not have the continuous impact on pricing in the future that these determinations have had in the past.