Obtaining Payer Coverage for New Tests Continues to Be Difficult

By on August 3, 2021

Clinical laboratories continue to face challenges to obtain positive coverage decisions by government and private payers for new tests. According to McDermott+Consulting Senior Director Deborah Godes, payers require reasons to establish new coverage assays.

“[The] key to getting a positive coverage decision from payers is making a solid case through good quality evidence,” Godes notes in a recent Dark Report article. “Clinical laboratories need to demonstrate that a particular assay actually works as it is intended and also that it is used by clinicians to make decisions regarding patient care. ”

Not all payers will be persuaded by the same arguments. Each payer has its own coverage determination process, and clinical laboratories should be prepared to deal with each one individually.

“You need to determine what drives that payer’s denials and then present evidence to address those concerns,” Godes says.

Access the article.

Deborah GodesDeborah Godes
Deborah is a seasoned regulatory and reimbursement consultant, advising clients on reimbursement and policy strategy for medical devices, diagnostics, biologics and health services with public and private payers. She focuses primarily on market access (e.g., coding, coverage, payment and other reimbursement models) for new and existing products and services, including AI-powered solutions. She has more than 20 years of experience providing strategic, operational and policy consultative services to companies of all sizes, from start-ups to Fortune 100 companies. Deborah offers clients the ability to analyze and manipulate reimbursement databases to buttress data-oriented policy positions. Read Deborah Godes's full bio.

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