ADLM 2026 Debrief: FDA Stepped Back, Payers Stepped Up
Avania Fireside Chat • Live Panel + Q&A | Tuesday, August 11 • 1:00 PM ET / 10:00 AM
The LDT rule is gone, and the data that sets your 2027 Medicare rates was reported this month. Two Avania IVD experts on what they took away from a week in Anaheim.
ADLM 2026 closed in Anaheim on July 30. Subo Perampalam and Eric Lam spent the week there, in sessions and on the expo floor, talking to regulatory leads, lab directors, and commercial teams. This session is what they took away from it.
The last twelve months moved US diagnostics in two opposite directions. The FDA rule that would have brought laboratory developed tests under device regulation was vacated by a federal court and formally rescinded by the agency, closing the premarket question that dominated laboratory planning for two years. Reimbursement moved the other way. The private payor data that sets Medicare Clinical Laboratory Fee Schedule rates for 2027 through 2029 was reported this summer, and MolDX continues to hold new molecular tests to a clinical utility standard before a claim can be paid.
For most diagnostics teams that combination is disorienting. The obstacle they spent two years preparing for is gone, and the one that determines whether they collect revenue never moved. A test can now reach the market with no federal premarket submission and still be unable to bill Medicare.
In 45 minutes of conversation plus live Q&A, Subo and Eric work through what actually changed, what they heard from the people they met in Anaheim, and what US diagnostics teams should decide before January. The through-line: regulatory risk did not decrease this year, it relocated.
What You’ll Walk Away With
| You’ll understand | Specifically |
|---|---|
| What the LDT vacatur actually changed | Why the FDA premarket question is closed, what CLIA and state oversight still require, why kits are still devices, and why a vacated rule is durable ambiguity rather than a settled framework. |
| Your 2027 CLFS exposure | The pricing input is already submitted. Which codes sit in the affected set, what a 15% per-test reduction does to gross margin, and what can still be influenced. |
| Coverage as the real constraint | Why analytical validity satisfies a lab director and clinical utility satisfies a payer, and why the MolDX technical assessment runs on a longer clock than most launch plans assume. |
| The framework question, live again | Service under CLIA or kit as a device. With the rule gone this distinction is determinative again, and many portfolios have quietly drifted since 2024. |
| A dated decision list | Five decisions for the next two quarters, in sequence, none of which require a new rule to be published. |
Your Speakers
SVP, Market Access & Reimbursement
Eric Lam, PhD
10+ years in IVD market access, built on a PhD in pharmacology and an NIH post-doctoral fellowship. Deep expertise in MolDX coverage, Advanced Diagnostic Laboratory Test applications, and novel coding strategy. Carries the payment half of the conversation.
Sr. Regulatory Consultant, IVD Expert
Subo Perampalam, PhD
IVD specialist with 20+ years in diagnostic product development and regulatory clearance, including product leadership at SQI Diagnostics and Nicoya Diagnostics. Carries the regulatory half of the conversation.
Built For:
- Regulatory affairs leaders at US diagnostics and molecular testing companies
- Laboratory directors and clinical operations leaders weighing what the LDT vacatur changed for them
- Market access, reimbursement, and commercial leaders modeling 2027 CLFS exposure
- Diagnostics founders and executives whose regulatory and reimbursement work sits with different teams
Reserve Your Spot
Free to attend. Complete the form and you’ll receive a confirmation email with your unique join link.