NEWS RELEASE

Concerns Remain on Palmetto GBA Final LCD for Multiplex Nucleic Acid Amplified Tests for Foodborne Gastrointestinal Panels

The draft local coverage determination finalized by Medicare contractor Palmetto GBA for Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs), released on October 26 and effective December 10, is responsive to some concerns raised by the Infectious Diseases Society of America but leaves other issues unaddressed.

In a joint 2017 comment letter, IDSA and other stakeholders requested that Palmetto:

• allow for coverage of additional pathogens to enable precise microbial identification, particularly for immunocompromised and elderly patients;
• expand indications for gastrointestinal pathogen panel (GIP) testing;
• and add approximately 200 ICD-10 codes to the covered targets list.

IDSA also submitted a May 2018 sign-on letter from members in Palmetto’s jurisdiction, which comprises seven states in the southeastern United States (AL, GA, TN, NC, SC, VA, WV), to underscore the importance of these tests in quickly diagnosing and treating vulnerable patients. Palmetto’s expanded coverage is in accordance with some of those recommendations.

As a result of these comments, Palmetto modified its policy to allow expanded testing for the presence of 6-11 pathogens and to allow for testing of additional organisms, particularly Clostridium difficile. Palmetto also accepted 24 of the codes we recommended be added for coverage.

The Society, however, remains concerned by a lack of additional ICD-10 codes and by Palmetto’s failure to address our remaining comments in their public response. Also concerning is Medicare’s assertion that testing for viral etiologies is not reasonable and necessary, when the ability to confirm a viral diagnosis in the real-world setting could prevent the acquisition of C. difficile and antimicrobial resistance in a significant number of patients.

The other Medicare A/B molecular diagnostics contractors – Cigna Government Services, Noridian, and Wisconsin Physicians Service – have not yet finalized their draft policies. IDSA will continue to advocate for appropriate reimbursement for critical infectious diseases diagnostic tests.