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).

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.

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.

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!

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)

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.

CMS Announces NCCI Edits will be Rescinded

Following NILA's August 15th letter to CMS, we are thrilled that CMS announced that the NCCI edits will be rescinded in response to NILA and other stakeholder's advocacy efforts.

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.

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.

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.

SALSA introduced in the 118th Congress

On Tuesday, March 28 the bipartisan, bicameral sponsors of the Saving Access to Laboratory Services Act (SALSA) reintroduced the legislation in the 118th Congress.

NILA Releases Statement on Reauthorization of the Pandemics and All Hazards Preparedness Act (PAHPA)

On March 27, 2023, NILA issued a statement on the reauthorization of the Pandemics and All Hazards Preparedness Act (PAHPA).

SALSA to be Reintroduced Soon

Bipartisan sponsors of the Saving Access to Laboratory Services Act (SALSA) are preparing for reintroduction of the legislation as soon as next week.

COVID-19 Public Health Emergency to End May 11, 2023

As we have reported, the Biden Administration announced plans to end the Public Health Emergency (PHE) on May 11, 2023.

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