POLICY PRIORITIES

The pandemic revealed substantial price deviation for similar tests. An analysis from the Kaiser Family Foundation found that list prices for COVID testing ranged from $20 to $1,419. Pricing and reimbursement uncertainty poses challenges for payer, provider, and laboratory communities – a more stable and sustainable pathway forward is necessary and in everyone’s best interests.

Since the release of a 2014 draft guidance from the FDA, the lab community has reeled from a potential change in regulatory oversight. Laboratory-developed tests (LDTs) are considered medical devices in many instances by the FDA, but FDA has issued enforcement discretion awaiting clear regulatory direction from Congress. Congress has been unable to specify whether it prefers traditional regulation by CMS under the Clinical Laboratory Improvement Amendments (CLIA) or direct regulation by the FDA, but legislation has been introduced on both sides of the argument and will play out this Congress over the next year.

CMS clarified that during the pandemic, medical necessity requirements would remain a prerequisite to coverage. However, guidance documents issued by both the Trump and Biden administrations failed to provide certainty for reimbursement for COVID testing leaving open the question of whether insurers or public health entities will be caught with the bill. Additionally, a delayed rulemaking from CMS raises the potential for breakthrough technologies to receive temporary, automatic coverage as reasonable and necessary under Medicare.

Advanced lab testing and genomic sequencing hold the key to enhanced clinical diagnoses, medical research, and the promise of precision medicine. However, uncertain regulation and high costs place questions around the future availability of these testing regimes. Ensuring consistent quality and availability of lab testing across payers and communities – especially the underserved – can help drive improvement to health outcomes, disease management, and prevention where health care delivery has left many behind.