According to those involved in the clinical testing community, several key issues hampered labs’ ability to respond quickly to the current COVID-19 pandemic, and will be problematic in tackling future public health emergencies if they are not addressed. A report released April 19 by the Association for Molecular Pathology (AMP), takes a deep dive into the first two years of the current pandemic and its effects on the clinical testing industry, offering ways to prevent or at least lessen the impact of the key issues going forward.
The report, “Economics of Clinical Testing during a Public Health Emergency: Lessons Learned from Two Years of COVID-19,” examined different pricing policies, coverage, and coding issues and put forth 15 recommendations to government agencies and other policymakers, which are broken down into five key areas summarized below:
1. Coding
The Centers for Medicare & Medicaid Services (CMS) should work closely with the clinical testing community to develop up-to-date, easy-to-understand coding guidance specific to the pandemic as well as create a process for developing this guidance quickly.
2. Pricing
CMS should work to ensure pricing accuracy as it applies to real world public health emergencies, consider all laboratory stakeholders, ensure adequate reimbursement, and consider the unique factors of a pandemic when it comes to pricing decisions.
3. Coverage
Policymakers should ensure emergency coverage policies are not more restrictive than non-emergency ones, CMS should make sure local coverage policies support all testing needed to inform diagnosis and treatment in an emergency, restrictive ordering requirements for tests should be removed, the U.S. Department of Health & Human Services (HHS) and CMS should provide transparent guidance for labs, and HHS needs to provide easy-to-understand guidance for private payers.
4. Genomic Sequencing
Federal funding and guidance that all clinical labs can access must be developed to ensure the sequencing of a wide range of clinical samples across the US for proper public health surveillance.
5. Reporting Requirements
The federal government must work with public health and clinical labs to ensure that proper resources and funding for laboratory reporting are accessible at the start of future pandemics.