TAG:
American Clinical Laboratory Association
On Appeal, ACLA Gains PAMA Victory in Court
CEO SUMMARY: Last month, a U.S. Court of Appeals issued a ruling that criticized how the Department of Health and Human Services originally implemented the Protecting Access to Medicare Act of 2014 (PAMA). This ruling was a win for the American Clinical Laboratory Association in its…
PAMA Cuts Might Be Reduced to Zero for 2023
CEO SUMMARY: Congress may soon vote on a new bill that permanently reduces the amount of price cuts to Medicare Part B lab test prices, as specified under the Protecting Access to Medicare Act of 2014 (PAMA). The Saving Access to Laboratory Services Act (SALSA) eliminates a 15% paym…
January 31, 2022 Intelligence: Late-Breaking Lab News
DNA-based breast cancer testing is taking a step forward.Ā Illumina in San Diego, which sells next-generation sequencing (NGS) technology, announced a partnership with Agendia in Irvine, Calif., to develop in vitro diagnostic tests for oncology. Agendia offers proprietary breast …
PAMA Test Price Cuts Deferred: Itās a āHuge Winā for Labs
TWO BIPARTISAN VOTES IN THE U.S. HOUSE OF REPRESENTATIVES AND SENATE will save clinical laboratories from another year of deep payment cuts imposed under the Protecting Access to Medicare Act of 2014 (PAMA).Ā āThis is a huge win for clinical labs,ā s…
Congress May Soon Act on LDT, IVCT Regulation
CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…
Congress May Soon Act on IVCT, LDT Regulation
This is an excerpt of a 2,017-word article in the November 29, 2021 issue of Ā THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …
MedPAC Reports to Congress on Issues in Lab Test Price Survey
IN THE HALLS OF CONGRESS, A GOOD NEWS/BAD NEWS STORY is unfolding around the multi-year cuts to the prices Medicare pays for clinical laboratory tests. First the good news.Ā In its latest semi-annual report toĀ Congress, theĀ Medicare PaymentĀ …
September 27, 2021 Intelligence: Late-Breaking Lab News
Following the opening of her criminal trial in a Silicon Valley courtroom in recent weeks, Elizabeth Holmesāthe disgraced ex-Founder and CEO of Theranosācontinues to be the subject of news headlines. Federal prosecutors are calling witnesses to testify. Much of this testimony includes anec…
Federal Judge Rules Against ACLA in Its PAMA Lawsuit
CEO SUMMARY: Now that a federal judge has ruled that the American Clinical Laboratory Associationās lawsuit is moot and dismissed the case, it is unclear what next steps are open to ACLA and the clinical laboratory industry in their challenge to how the federal Centers for Medicar…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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