MGMA letter to Congress on LDT proposed rule (March 20, 2024)

March 20, 2024 
 

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. The FDA is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. The proposed rule phases out the FDA’s general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would fall under the same enforcement approach as other IVDs. The proposed oversight framework includes premarket review requirements. FDA’s stated intent in proposing this phaseout is to better protect public health by helping to ensure the safety and effectiveness of LDTs.

View the full letter