Respiratory Pathogen Panel Testing

Jurisdiction: JH MAC Part B. States: Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, Texas. Type: Active LCD

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits. History/Background and/or General Information Diagnostic testing for identification of pathogens that are causative for respiratory infections has evolved over the years. The aim is for rapid, accurate, and sensitive identification in an effort to improve patient outcomes through improved clinical decision making. These new technologies include nucleic acid-based amplification techniques. The focus of this LCD is respiratory pathogen panel testing, which typically includes detection for multiple virus pathogens by amplification of target DNA and is currently the most popular technique that can provide rapid, accurate, and sensitive results. 1 Even with the widespread use of respiratory pathogen panel testing, only a few methods are available that not only detect respiratory pathogens but are also U.S. Food and Drug Administration (FDA) approved. Please see the FDA link for approved/cleared respiratory pathogen panel tests. https://www.fda.gov/. 2 It is recognized that labs may not have FDA approval/clearance of their products, i.e., laboratory developed tests (LDTs). At the time of this publication, tests are not limited to FDA approved/cleared products only. Coverage for tests is based on demonstration of analytical and clinical validity and clinical utility at a level that meets the Medicare medically reasonable and necessary requirement. Covered Indications Respiratory pathogen panel testing in the outpatient setting by a Part B provider (e.g., physician's office, independent clinical laboratory) will be considered medically reasonable and necessary when all of the following are met: Panels with ≤5 respiratory pathogens are performed, and BOTH of the following criteria are met: The outpatient setting is equipped to deliver timely reporting of results to providers AND , For patients where the test result aids clinical management with the goal of an improved health outcome for the patient. Limitations The following is considered not medically reasonable and necessary: Panels with >5 respiratory pathogens performed in the Part B outpatient setting. 3 Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.