CMS Proposed Rule on Clinical Laboratory Test Reimbursement

The U.S. Centers for Medicare & Medicaid Services (CMS) recently released a proposed rule (80 Fed. Reg. 59386, 10/1/15) on how Medicare determines reimbursement payment within the Clinical Laboratory Fee Schedule (CLFS).  This action was based upon Section 216 of the Protecting Access to Medicare Act of 2014 (Pub. L. No. 113-93, title II, §216(a), 128 Stat. 1053, 4/1/14; 42 U.S.C. 1395m-1).  The current CLFS was adopted in 1984, and has only had occasional minor changes/updates for new tests and statutory across-the-board updates.  The proposed new system is envisioned to begin 1/1/17, and be based upon data from reports on private insurance payments and test volume from “applicable laboratories” (ie, laboratories for which the majority of their Medicare revenues are paid under the CLFS or Physician Fee Schedule).  To better reflect private payer market rates, the new system will also be updated more regularly – triennially for clinical diagnostic laboratory tests and annually for advanced diagnostic laboratory tests.  The CMS will receive comments on the proposed rule until  5pm on 11/24/15.  For additional information, see the CMS Medicare Clinical Diagnostic Laboratory Tests Payment System Proposed Rule Fact Sheet.