FEATURED ISSUE
Who controls your diagnostic lab test is important
If your personal healthcare includes some alternative lab testing to track what is going on with your health, what continues to be evolving with federal regulations related to the laboratory developed tests (LDTs) will most likely be of interest to you. Currently LDTs are regulated by the Centers for Medicare and Medicaid Services (CMS). For some time, the U.S. Food & Drug Administration (FDA) has been working to have greater control over LDT regulations. After just missing their goal in 2022, the FDA has gone on notice that it is trying again. The specifics for the latest attempt are scheduled to be released this month (August 2023). Are you interested in some support for understanding the pros and cons of who controls LDT regulations?

ISSUE: How can you follow expected FDA proposed LDT changes?

AHHA strives to maintain a neutral position and views knowledge as power. For those interested in this month’s Issue, the following articles have been selected so that you can have a greater understanding of the history of FDA attempts to change LDTs regulations, and a variety of concerns other organizations suggest you look for in the latest changes. You are encouraged to delve deeper and expand your knowledge of this matter using these articles as a springboard.

What is CMS’ authority regarding Laboratory Developed Tests (LDTs) and how does it differ from FDA’s authority?
Clinical Laboratory Improvement Amendments (CLIA) program
[Currently: The Clinical Laboratory Improvement Amendments (CLIA) program regulates laboratories that perform testing on patient specimens in order to ensure accurate and reliable test results. The FDA regulates manufacturers and devices under the Federal Food, Drug, and Cosmetic Act (FFDCA) to ensure that devices, including those intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are reasonably safe and effective.]

LDT Reform: If Congress Won’t Do It, We Will, Says FDA (4/18/23)
American Society for Clinical Pathology (ASCP)
[While it may sound like decisive action, the new noises coming from the FDA about taking the LDT reform bull by the horns may be more show than substance, perhaps designed to light a fire under Congress. For one thing, it’s far from clear that the FDA even has the legal authority to regulate LDTs or lab tests in general. The agency has long contended that regulating lab tests is an extension of its authority to regulate medical devices under the Food, Drug, and Cosmetic Act (FDCA). But that theory could be challenged in federal court were the agency to seek to implement LDT regulation on its own without a new legislative mandate from Congress. It’s unclear whether the agency would be willing to risk such a high-stakes legal fight.]

Medical Devices; Laboratory Developed Tests
Office of Information and Regulatory Affairs
[Proposed Rule Stage: This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.]

FDA Announces: Regulations about LDT’s are Coming Very Soon (6/28/23)
Discoveries in Health Policy
[In a dry and brief federal regulations announcement, FDA has formally announced that it plans to issue regulations about LDTs, lab developed tests, very soon. Expect proposed regulations by August 2023.]

FDA moves to restructure LDT regulation through notice of proposed rulemaking and oncology LDT pilot program (7/20/23)
by Bethany Hills. Christopher Mikson. Adam Donat, Margaret Martin, Hilary Hoffman. Jianyuan Hua
DLA Piper
[Potential public policy challenges include arguments that many critical tests are available only as LDTs; that FDA regulation will impede and slow important innovation and patient access; and that other solutions to address FDA’s concerns are available and superior to FDA regulation and oversight of LDTs.]

 FDA’s Lab Test Power-Grab Continues (7/20/23)
Alliance for Natural Health USA
[Currently, laboratories have the flexibility to adapt and modify tests based on evolving scientific knowledge and patient requirements. That could all change if the FDA wins.]

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