The DIASORIN Podcast, "Beyond the Result," brings us an interview with Dr Gabriel Bien-Willner. It's titled, "The Payer Perspective: Driving Diagnostic Stewardship and Smarter Coverage Policies.”
Find it at YouTube, here:
https://www.youtube.com/watch?v=KfXZAd9N5qc
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Here's an AI summary of the 40-minute interview.
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In a recent episode of Beyond the Result, DiaSorin’s Luminex division podcast, host Angelo Rago interviewed Dr. Gabriel Bien-Willner, Chief Medical Officer of MolDx, the Medicare program that has become a central force in U.S. molecular diagnostics coverage. The conversation offered a rare inside look at how MolDx has reshaped reimbursement policy to better align innovation, evidence, and diagnostic stewardship.
Dr. Bien-Willner explained that MolDx was launched in 2012 by Palmetto GBA, a Medicare Administrative Contractor, to address a fundamental problem: traditional CPT coding could not adequately describe what modern molecular tests actually do. In response, MolDx introduced a test registry and Z-codes, requiring laboratories to precisely define each test—its analytes, methods, intended use, and clinical context—before Medicare reimbursement. This infrastructure allows payers to understand not just that a test was billed, but what was tested and why.
Over time, MolDx has expanded from human DNA and RNA testing to a broader range of molecular diagnostics and is now used across 28 states, with multiple Medicare contractors adopting its shared policies and tools. Bien-Willner emphasized that MolDx’s approach is not about limiting innovation, but about ensuring that new tests demonstrate they are “reasonable and necessary”—Medicare’s statutory standard—through credible evidence.
A major theme of the discussion was diagnostic stewardship: using the right test for the right patient at the right time. Bien-Willner described how MolDx policies have evolved away from rigid, test-specific coverage toward foundational, future-proof frameworks. These policies define evidence thresholds rather than naming specific products, allowing coverage to expand naturally as science matures. He cited next-generation sequencing in oncology and minimal residual disease testing as examples where MolDx policies have successfully accommodated rapid innovation without repeated rewrites.
Addressing concerns that reimbursement can stifle adoption, Bien-Willner argued the opposite: well-designed policy enables innovation by separating high-value diagnostics from waste and abuse. MolDx, he said, aims to act not as a blunt instrument, but as a scalpel, protecting the Medicare trust fund while ensuring that effective, evidence-based diagnostics can thrive.
For laboratories and industry, his advice was clear: engage payers as partners, understand their evidentiary standards, and recognize that sustainable innovation depends as much on policy design as on scientific breakthroughs.
SIDEBAR
5 Interesting, Slightly Surprising Takeaways
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MolDx exists partly because CPT is [mathematically] “degenerate.” Bien-Willner’s blunt point: for molecular testing, a CPT code often can’t tell a payer what was actually tested—so the claim can’t be meaningfully adjudicated without extra structure.
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The “Z-code” is basically Medicare’s “tell me exactly what this test is” tag. It’s not just paperwork—it’s how MolDx ties coverage decisions to a specific lab’s specific LDT, rather than to a broad, ambiguous billing code.
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He reframed diagnostic stewardship as “separation of powers.” Providers treat; payers pay. In his analogy, the payer is a built-in “sanity check” like the friend who tells you the dealership’s $4,000 repair might be overkill.
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MolDx changed its philosophy on panels—more permissive, but also more logical. He described moving away from “if any analyte isn’t necessary, the whole panel fails” toward “a panel should include everything reasonably needed—avoid partial testing + stacking.”
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He’s trying to write coverage policy like software. His “foundational policy” approach uses conditional logic (“if X and Y, and one of A/B/C…”) to make policies future-proof, so new tests can qualify as evidence evolves without rewriting the whole LCD every year.