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    March 20, 2024 

    The Honorable Brett Guthrie The Honorable Anna Eshoo
    Chairman Ranking Member
    House Committee on Energy and Commerce House Committee on Energy and Commerce
    Subcommittee on Health Subcommittee on Health
    2123 Rayburn House Office Building 2123 Rayburn House Office Building
    Washington, DC 20515 Washington, DC 20515


    Re: House Committee on Energy and Commerce Subcommittee on Health hearing titled, “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule”

    Dear Chairman Guthrie and Ranking Member Eshoo:

    The Medical Group Management Association (MGMA) thanks the Subcommittee for holding this important hearing examining the Food and Drug Administration’s (FDA) proposed rule (88 FR 68006) to regulate laboratory developed tests (LDTs) and alternative approaches to diagnostic regulation. MGMA recognizes the FDA's efforts to ensure the safety and effectiveness of LDTs through the proposed oversight framework. However, we have serious concerns that regulating LDTs as medical devices could inadvertently limit patient access to critical clinical testing.

    With a membership of more than 60,000 medical practice administrators, executives, and leaders, MGMA represents more than 15,000 medical groups comprising more than 350,000 physicians. These groups range from small independent practices in remote and other underserved areas, to large regional and national health systems that cover the full spectrum of physician specialties.

    For years, MGMA has advocated for a robust clinical laboratory infrastructure to support the delivery of routine patient care. Medical groups rely on LDTs to provide essential diagnostic and testing services to patients. MGMA requested a pause in rulemaking in response to the FDA’s proposed rule.


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