Lab Matters Winter 2019 | Page 18

FOOD SAFETY & INFECTIOUS DISEASES New Reimbursement Limits on Respiratory Viral, GIP Panels: Will They Impact Detection, Surveillance of Foodborne and Respiratory Diseases? By Kristy Kubota, MPH, manager, PulseNet and Anna Tate, MPH, senior specialist, Respiratory Diseases Gastrointestinal Pathogen Panel Palmetto Local Coverage Determination GIP testing limited to up to five bacterial pathogens: Salmonella, Campylobacter, Shigella, Cryptosporidium, and STEC (O157 and non O157). If Clostridium difficile colitis is of concern, the contractor will cover up to 11 targets if Clostridium difficile is one of the organisms tested. Salmonella Since 2013, several manufacturers have received FDA clearance of culture- independent diagnostic tests (CIDTs) for the detection of viral, bacterial and parasitic agents involved in an array of respiratory and enteric diseases. While there is inherent utility of CIDT panels for both clinical management and public health surveillance, adoption of CIDTs presents new challenges and warrants careful scientific consideration within a jurisdiction. Moreover, manufacturers have added new analytes to these panels over time, sometimes without clearly demonstrating added benefit or clinical utility. Antiquated reimbursement policies focused on per-analyte fees are not well adapted. Since the Centers for Medicare and Medicaid Services (CMS) and private insurance entities regulate clinical laboratories’ billing, they ultimately determine which diseases and conditions are covered (i.e., reimbursed) under national and local purviews. This was notable in several recent coverage 16 LAB MATTERS Winter 2019 determinations for respiratory viral and foodborne gastrointestinal pathogen (GIP) panels. 1. Expand coverage for respiratory viral assays when determined to be clinically warranted Proposed Reimbursement of NAATs: Local Coverage Determinations 2. Consider per-panel (rather than per-pathogen) reimbursement In 2017 and 2018, a number of Medicare Administrative Contractors (MACs) issued molecular diagnostic (MolDX) draft local coverage determinations (dLCDs) for reimbursement of both respiratory viral and GIP panels identified by the most common type of CIDT–multiplex nucleic acid amplification tests (NAATs). Draft LCDs for viral respiratory panels were issued across multiple reimbursement jurisdictions, indicating a non-coverage policy. Similarly, draft LCD proposals for GIP panels limited coverage to just five bacterial targets. In response to these dLCDs, APHL joined partner organizations to submit letters during the public open comment period urging MACs to: 3. Consider the public health impact when making LCDs concerning pathogens of public health significance 4. Expand GIP panel coverage to the top 90-95% of foodborne infections considered medically necessary for therapeutic decision-making. Impact of Final Ruling on Clinical and Public Health Labs In September 2018, one of these MACs, Palmetto, issued a response to public comments, citing that respiratory viral panels do not meet Medicare’s “reasonable and necessary” criteria and that public health surveillance testing does not qualify as a Medicare benefit. In October 2018, Palmetto issued final LCDs for respiratory viral panels, allowing for PublicHealthLabs @APHL