Non-Standardized Organ or Disease-Oriented Panels (DL32286)
September 30, 2011Effective for dates of service 02/27/2012 and forward, Palmetto will consider “non covered” all non-standardized organ or disease-oriented panels that meet the following criteria: 1. Are non-FDA cleared laboratory developed tests (LDTs) 2. Are performed or marketed by a sole source, hospital, or reference laboratory 3. Have not received a specific AMA CPT code 4. Have not obtained an NCD or LCD coverage determination from Palmetto GBA 5. Tests that require multiple CPT codes in order to submit a claim for a single assay/test Palmetto states that only the standard procedure reporting manuals CPT and HIPS may generate test panel definitions. Services reported with multiple codes and a single and/or multiple units of service to represent a single test panel are considered investigational and therefore not a covered service. Test panels submitted and paid that have NOT been reviewed and approved by Palmetto are considered investigational and will be subject to overpayment collection. Once approved, the test(s) will be effective for the dates of service on and after the approval date of a coverage determination. Dates of Service prior to the approval effective date will be subject to the non-coverage policy, denied, and subject to overpayment collection. Unapproved panels will be subject to denial and overpayment collections. Comments on this draft policy are from 10/14/11 through 12/05/2011 The following Draft LCD policy was released by Palmetto J1 and will be introduced at the Oct 19th CAC meeting.