Draft Coverage Policy for Multiplex GI Tests Released

Medicare Administrative Contractors (MACs) First Coast and Novitas Solutions, whose combined jurisdictions cover 12 states, Puerto Rico, the U.S. Virgin Islands and the District of Columbia, have proposed identical payment policies for Gastrointestinal Pathogen Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (DL38229) that other MACs may soon adopt.

In the current draft, Novitas Solutions and First Coast recommend coverage for:

• A maximum of 11 or targets for Medicare beneficiaries with acute diarrhea and one other listed symptom;
• 12 or more targets for immunocompromised patients with acute diarrhea;
• No coverage for certain conditions determined not medically reasonable and necessary, including chronic diarrhea, repeat testing, asymptomatic pts, and cure.

Previously, IDSA and other laboratory organizations commented on a similar payment policy for foodborne GI pathogens from molecular diagnostic MACs to share recommendations regarding limited or nonexistent coverage and to suggest additional ICD-10 codes.

IDSA and the American Gastroenterological Association (AGA), American Society for Microbiology (ASM), Association for Molecular Pathology (AMP), Association of Public Health Laboratories, (APHL), College of American Pathologists (CAP), and Pan American Society for Clinical Virology (PASCV) drafted joint comments to Novitas Solutions and First Coast detailing concerns about aspects of coverage indications, limitations, and summary of the evidence outlined in the draft policy that do not appropriately align with current clinical practice.

Stakeholders requested that the draft policy:

• Allow for coverage of panels utilizing multiplex NAATs for persistent or chronic diarrhea when medically reasonable and necessary;
• Include coverage for norovirus, astrovirus, sapovirus and adenovirus in immunocompromised patients with diarrhea; and
• Add determination of whether a difficile strain carries the toxin B gene in the summary of evidence.

While improvements to the MAC drafting process have strengthened the scientific literature and coverage recommendations to an extent, the Society remains concerned by impeded access to public MAC meetings and failure to post meeting summaries in a timely manner as indicated. IDSA will continue to advocate for appropriate reimbursement for critical infectious diseases diagnostic tests.