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CMMI Engagement on CGT Model
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Publications
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ADVI Expert Insights
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Why Clinical Laboratories Should Consider Weighing In on CMS and CDC’s New CLIA Request for Information
An opportunity for laboratories to help shape the future of CLIA regulation On July 16, 2026, the Centers for Medicare …
Stacey Gilbert, MPH, MBA
July 27, 2026
RAND/UCLA Modified Delphi Panels
ADVI Health partners with pharmaceutical and biotech organizations to advance their evidence generation and market access strategies. We support complex research questions through primary research (e.g., …
Caitlin Sheetz, MPH
June 23, 2026
Test Ordering Simplification Will Not Be Optional in the Near Future: Why Labs Must Act Before May 26, 2028
The Centers for Medicare & Medicaid Services’ (CMS) Administrative Simplification: Adoption of Standards for Health Care Claims Attachments Transactions and …
Stacey Gilbert, MPH, MBA
May 11, 2026
The MolDX Technical Assessment: How to Move Your Test from “Not Successful” to Medicare Coverage Success
In the laboratory space, the MolDX Technical Assessment (TA) is often the moment where the gap between “a great test” …
Stacey Gilbert, MPH, MBA
April 9, 2026
CRUSH and Genetic and Molecular Laboratories: A Potential Shift in Medicare Oversight
Genetic, molecular, and reference laboratories are closely watching a new Medicare concept known as CRUSH- short for Comprehensive Regulations to …
Stacey Gilbert, MPH, MBA
March 17, 2026
March Is Colorectal Cancer Awareness Month: Why CMS’s Proposed NCD 210.3 Update Could Accelerate Patient‑Centered Screening Access
Colorectal cancer (CRC) screening saves lives, but only when patients are able to access care in a way that meets …
Stacey Gilbert, MPH, MBA
March 17, 2026
MFN shifts from noise to credible threat
Throughout 2025, MFN-like concepts were diffuse background noise. That volume intensified in Q4, when legislative and regulatory conversations crystallized around …
Marc Samuels, JD, MPH
March 16, 2026
The 2026 Rare Disease Reality
Orphan drugs now represent approximately 20 percent of total prescription spend, and over 52 percent of the cell and gene …
Marc Samuels, JD, MPH
February 26, 2026
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