Several Times, Feds Tried to ‘Redirect’ Lab Activities

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…

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Year’s Top 10 Lab Stories Contain Surprises & Twists

By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue

CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nation’s clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence…

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Congress Delays PAMA Fee Cuts, Passage of SALSA Act Is Goal

By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue

ONCE AGAIN, THE CLINICAL LABORATORY INDUSTRY DODGED THE MEDICARE FEE-CUT BULLET. Last month, Congress passed a bill that included a one-year reprieve to the impending PAMA reimbursement cuts that were scheduled to take place on January 1, 2024. The lab industry…

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FDA’s Road to Regulation of Lab Developed Tests

By Robert Michel | From the Volume XXX, No. 14 – October 2, 2023 Issue

CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LD…

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SALSA Bill Resurfaces, Poised to Reduce Upcoming PAMA Cuts

By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue

ANOTHER ROUND OF STIFF PRICE CUTS TO THE MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE (CLFS) is just months away, with the provisions of the Protecting Access to Medicare Act (PAMA) set to resume on Jan. 1. In…

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No Surprises Act Sparks a Slew of Court Decisions

By Scott Wallask | From the Volume XXX, No. 13 – September 11, 2023 Issue

CEO SUMMARY: Multiple lawsuits filed by the Texas Medical Association against the federal government have resulted in key decisions that affect provisions in the law. Qualifying payment amounts and …

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PAMA Cuts Have Simply Been Kicked Down the Road

By R. Lewis Dark | From the Volume XXX, No. 1 – January 3, 2023 Issue

PAYMENT RATE CUTS FOR CLINICAL LABORATORY TESTS, called for under the Protecting Access to Medicare Act of 2014 (PAMA), have been avoided temporarily—again.  A down-to-the-wire bill in Congress to keep the federal government funded into the new year in…

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Congress Averts PAMA Cuts to Lab Test Rates for 2023

By Scott Wallask | From the Volume XXX, No. 1 – January 3, 2023 Issue

CONGRESS ENACTED LEGISLATION LAST MONTH that suspends implementation of the next round of price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) that was scheduled to take effect on Jan. 1. This is a welcome development for the medical laboratory industry….

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2022’s Top 10 Lab Stories Confirm Challenging Times

By Scott Wallask | From the Volume XXIX, No. 17 – December 12, 2022 Issue

CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …

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VALID and SALSA Acts Still Pending in Congress

By Scott Wallask | From the Volume XXIX, No. 16 – November 21, 2022 Issue

CEO SUMMARY: Both the pending VALID Act and SALSA Act continue to push ahead as 2022 comes to an end. Meanwhile, a new bill centered on the Physician Fee Schedule may protect pathologist payments. These three different proposals share something in common:…

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