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national independent laboratory association

Passage of FDA Regulation of LDTs Inches Closer in the Senate

CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …

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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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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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Attorney Explains Risks from New ‘Support Act’

CEO SUMMARY: Legislation signed into law on Oct. 24 was designed to stem the nation’s opioid crisis. But in addition to applying to sober homes and addiction treatment centers, the law also applies to clinical laboratories. Called the ‘Support for Patients and Communities Act,’ the …

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CMS Adjustments for Medicare Fee Schedule Might Be Too Late

This is a summary of two articles in the Nov. 13, 2018 issue of THE DARK REPORT. The complete articles are available only to paid members of the Dark Intelligence Group. CEO SUMMARY: On Nov. 2, the federal Centers for Medicare and Medicaid Services released its Physician Fee S…

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More Medicare Price Cuts Coming in 2019, 2020

How many consecutive 10% and 15% cuts to the prices Medicare pays for clinical laboratory tests can smaller community labs absorb before they are forced to shut their doors and go out of business? This nation is about to…

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NILA, ACLA Respond to CMS 2019 Final Lab Rule

CEO SUMMARY: On Nov. 2, the federal Centers for Medicare and Medicaid Services released its Physician Fee Schedule for 2019. It says it will expand the number of labs from which it collects data about the lab test prices paid by private health insurers. While some labs may welcome these c…

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