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McMillin Talks FDA LDT Rule in Inside Health Policy

January 30, 2024

Bobby McMillin, managing director of the firm’s Legislative & Public Policy practice, was recently quoted in the Inside Health Policy article, “Joint FDA, CMS Statement Signals Critics Of FDA LDT Rule Won’t Find Ally In CMS.” The article highlights the U.S. Centers for Medicare & Medicaid Services’ (CMS) alignment with the U.S. Food and Drug Administration’s (FDA) proposed rule that would strengthen FDA oversight over laboratory developed tests (LDTs).

According to the article, the FDA is pushing to finalize the rule by April 2024 in an effort to avoid it being subject to a “lookback period” if there is a change in administration next year. There remains a great deal of Congressional interest in the issue, and McMillin told Inside Health Policy that the House Energy and Commerce Committee “is likely to hold a hearing on the proposed rule before its finalized.”

Read the full article.