On May 6, 2024, the Food and Drug Administration (FDA) published the final rule defining how the agency will be changing enforcement discretion on LDTs. The rule is substantially changed from the preliminary rule published late last year. The changes are directly responsive to many of the concerns raised by ASCLS and other laboratory groups, which universally told FDA…
The Centers for Medicare and Medicaid Services (CMS) has published final rules related to personnel regulations under CLIA. The proposed rules were published in 2022 and generated thousands of comments back to the agency. The entire community of medical laboratory professionals had a significant impact on the final outcome. “Because of the work of so many…
The deadline to comment on a U.S. Food & Drug Administration (FDA) proposed rule to begin regulating Laboratory Developed Tests (LDTs) is December 4. ASCLS encourages all members of our community to read the proposal and provide input. The proposed rule would amend the FDA’s regulations to make explicit that LDTs (defined by FDA as…
The House of Representatives and Senate have passed approving a continuing resolution (CR) that includes a one-year delay of implementation of the PAMA Medicare payment cuts to clinical laboratory services and data reporting, until January, 2025. The President is expected to sign it into law this week. Thank you to all who participated in some…
On September 28, 2023, the American Society of Association Executives (ASAE) delivered a letter from 652 membership associations (including ASCLS) to the chairs and ranking members of the Senate Finance and House Ways and Means Committees in support of the Freedom to Invest in Tomorrow’s Workforce Act. The law would allow students, families and workers…
Solutions to the clinical laboratory’s biggest challenges are working their way through Congress, but they won’t become law without a major push from medical laboratory professionals, harder than we’ve ever pushed before. Finally, Acknowledgement on Laboratory Workforce Tomorrow, the Senate Health, Education, Labor and Pensions (HELP) Committee will begin work on the proposed Bipartisan Primary…
The Saving Access to Laboratory Services Act (SALSA) was introduced today in both the House and Senate by Senators Sherrod Brown (D-OH) and Tom Tillis (R-NC) and Representatives Gus Bilirakis (R-FL), Brian Fitzpatrick (R-PA), Richard Hudson (R-NC), Bill Pascrell (D-NJ), and Scott Peters (D-CA). This bill is the same as the one ASCLS and every…