A final rule updating CLIA fees and fee regulations and amending some personnel regulations was published in the December 28, 2023, Federal Register.
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.
NILA is thrilled to share that, thanks to your unwavering advocacy and grassroots efforts, we have achieved a victory for laboratories!
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)
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CMS Announces NCCI Edits will be Rescinded
Following NILA's August 15th letter to CMS, we are thrilled that CMS announced that the NCCI edits will be rescinded in response to NILA and other stakeholder's advocacy efforts.
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.
NILA Comments on Interoperability Issues
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.
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.
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.
As we have reported, the Biden Administration announced plans to end the Public Health Emergency (PHE) on May 11, 2023.
SALSA Reintroduction in the Works
Having achieved a one-year delay in reimbursement cuts and data reporting, permanently addressing the flawed implementation of the Protecting Access to Medicare Act (PAMA) remains a top priority for NILA.
The letter was sent on behalf of the American Association of Bioanalysts (AAB) and the National Independent Laboratory Association (NILA).
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