OIG Signals Interest in LDTs

Wednesday, November 28, 2012

Oversight of Laboratory-Developed Tests (New)
We will determine HHS agencies’ oversight of the clinical effectiveness of laboratory-developed tests (LDT). We will determine the extent and nature of LDT use for health care decisions and describe the challenges in regulating LDTs. The Medical Devices Amendments Act of 1976 provided FDA with the authority to regulate all medical devices, including in vitro diagnostics, for clinical effectiveness. LDTs, a category of in vitro diagnostics, have traditionally been used in research settings only. Because of this limited use, FDA has chosen to use regulatory discretion with respect to these tests and does not oversee them. LDTs are also subject to CMS oversight through its enforcement of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). However, CLIA addresses laboratory practices rather than the clinical effectiveness of the tests they conduct.
OIG 2013 Work Plan, p. 91

We're not going to bet anyone any lunches about what this statement means, whether it will lead to any change in enforcement or when such a change might take place.

That said, seeing this issue identified and prioritized in actual print on an actual government publication might be the most concrete progress we've made on this issue since... well, for a really long time.

Whatever happens next, OIG should get kudos for putting this issue back on the agenda. But I hope they've got an umbrealla, because I can already see people making a run on rotten fruit.

Tags: Enforcement, IVD, LDTs

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