NILA News
04/03/2025
Summary of Court Decision Nullifying FDA Regulations for LDTs
NILA attorney Michael Hawrylchak, Esq., has written a summary of the Texas Court's decision.
04/01/2025
FDA's LDT Regulations Struck Down by Texas Court
March 31, 2025, a Texas District Court vacated the FDA's rule regulating Laboratory Tests (LDTs) in its entirety, holding that the FDA's attempt to regulate laboratory services as medical devices exceeds the agency's statutory authority under the Food, Drug, and Cosmetic Act (FDCA). The court's decision can be viewed at the bottom of this Alert.
03/04/2025
NILA Meets for Lab Leaders Forum in San Antonio
The exclusive, members-only event featured expert-led seminars and spirited open discussions on critical industry topics.
01/08/2025
NILA's 2025 Lab Leaders Forum and Mid-Year Meeting to be Held Feb. 28-Mar. 1
Registration is open for NILA's members-only meeting at the Mokara Hotel and Spa in San Antonio.
10/08/2024
NILA and AAB File an Amicus Brief in Support of the ACLA and AMP Lawsuit Against FDA's LDT Rule
04/29/2024
NILA and American Association of Bioanalysts (AAB) Respond to FDA's Release of Final Rule on LDTs
The FDA released today its final rule on oversight of Laboratory Developed Tests (LDTs).
12/28/2023
CLIA Fees and Personnel Changes Published in Today's Federal Register
A final rule updating CLIA fees and fee regulations and amending some personnel regulations was published in the December 28, 2023, Federal Register.
12/05/2023
NILA and AAB Comment on FDA's Proposed LDT Rule
On October 3, 2023, the Food and Drug Administration (FDA) published a proposed rule, Medical Devices; Laboratory Developed Tests, that would amend regulations indicating that in vitro diagnostic tests (IVDs) are medical devices, including when the manufacturer of the IVD is a laboratory.
11/15/2023
House Passes 1-Year Delay of PAMA Reimbursement Cuts
NILA is thrilled to share that, thanks to your unwavering advocacy and grassroots efforts, we have achieved a victory for laboratories!
09/19/2023
NILA Urges OMB to Reconsider FDA's Proposed Rules Regulating LDTs
NILA is urging the White House to reconsider releasing the proposed rules allowing the Food and Drug Administration (FDA) to regulate Laboratory Developed Tests (LDTs)
09/19/2023
NILA Shares Concerns with House Leaders Regarding "Lower Costs, More Transparency Act"
In a September 18, 2023, letter to the Honorable Kevin McCarthy, Speaker of the U.S. House of Representatives, and the Honorable Hakeem Jeffries, Minority Leader of the U.S. House of Representatives, NILA expressed concerns with certain aspects of the Lower Costs, More Transparency Act.
09/13/2023
CMS Announces NCCI Edits will be Rescinded
Following NILA's August 15th letter to CMS, we are thrilled that CMS announced that the NCCI edits will be rescinded in response to NILA and other stakeholder's advocacy efforts.
09/07/2023
NILA Urges CMS to Withdraw NCCI Edit for Presumptive and Definitive Drug Tests
On August 15, 2023, NILA submitted a request to CMS Principal Deputy Administrator Jonathan Blum for a meeting to provide NILA's perspective on the recent implementation of a National Correct Coding Initiative (NCCI) edit for the coverage and payment for presumptive and definitive drug testing.
06/22/2023
NILA Comments on Interoperability Issues
05/22/2023
33 Healthcare Groups Sign Letter of Support for SALSA
Today, the National Independent Laboratory Association (NILA), the American Association of Bioanalysts, and an additional 31 leading provider organizations sent a letter to congressional leadership calling for enactment of the Saving Access to Laboratory Services Act (SALSA) prior to the end of the calendar year.
04/27/2023
VALID Act Re-Introduced in House of Representatives
Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) recently reintroduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act in the House of Representatives.
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