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January 31, 2022 Intelligence: Late-Breaking Lab News

DNA-based breast cancer testing is taking a step forward. 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 …

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PAMA Test Price Cuts Deferred: It’s a ‘Huge Win’ 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).  “This is a huge win for clinical labs,” s…

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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…

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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  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 …

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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.  In its latest semi-annual report to Congress, the Medicare Payment …

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Federal Judge Rules Against ACLA in Its PAMA Lawsuit

CEO SUMMARY: Now that a federal judge has ruled that the American Clinical Laboratory Association’s 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…

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Labs May Be Excluded from Revised Stark, AKS Rules

CEO SUMMARY: When CMS and the OIG issued proposed rules last fall to make it easier for providers to participate in value-based and coordinated care arrangements, they considered excluding clinical labs, pharma companies, and DME firms because of concerns that the proposed rules could pro…

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Labs May Be Excluded from Revised Stark Law, AKS Rules

This is an excerpt of a 1,460-word article in the Jan. 6, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Here are early insights about a federal compliance reform that has not gotten much attention among clinical la…

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ACLA Gets Procedural Win in Its Appeal of PAMA Case

IN A SIGNIFICANT WIN for the American Clinical Laboratory Association (ACLA) and other groups suing federal Department of Health and Human Services (HHS), the U.S. Court of Appeals for the District of Columbia ruled in the ACLA’s favor on July 30. Ruling on the ap…

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Bill Would Delay PAMA Reporting for One Year

CEO SUMMARY: For all laboratories that must report private payer price data under the Protecting Access to Medicare Act (PAMA), a new bill in congress would delay the next round of data reporting for one year and require the National Academy of Medicine to recommend ways to improve the da…

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