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national independent laboratory association
Attorney Explains Risks from New ‘Support Act’
By Joseph Burns | From the Volume XXV No. 17 – December 3, 2018 Issue
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 …
CMS Adjustments for Medicare Fee Schedule Might Be Too Late
By Mary Van Doren | From the Volume XXV No. 16 – November 13, 2018 Issue
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…
More Medicare Price Cuts Coming in 2019, 2020
By R. Lewis Dark | From the Volume XXV No. 16 – November 13, 2018 Issue
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…
NILA, ACLA Respond to CMS 2019 Final Lab Rule
By Joseph Burns | From the Volume XXV No. 16 – November 13, 2018 Issue
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…
ACLA Lawyer Says Judge’s PAMA Ruling Is Narrow
By Joseph Burns | From the Volume XXV No. 14 – October 1, 2018 Issue
CEO SUMMARY: Many lab professionals were disappointed at the news that a federal judge dismissed the American Clinical Laboratory Association’s arguments in its lawsuit against the federal Department of Health and Human Services (HHS). In an interview, the ACLA’s lead lawyer on the ca…
Court Dismisses ACLA Claims in PAMA Case
By Joseph Burns | From the Volume XXV No. 14 – October 1, 2018 Issue
CEO SUMMARY: While acknowledging that the American Clinical Laboratory Association raises important questions in its case against the federal Department of Health and Human Services, a district court judge ruled that the court cannot resolve the dispute and dismissed the ACLA’s claims f…
CMS physician fee schedule: Will hospital labs be excluded again from PAMA price reporting?
By R. Lewis Dark | From the Volume XXV No. 11 – July 30, 2018 Issue
CEO SUMMARY: Publication of the draft CMS Physician Fee Schedule on July 12 brought unwelcome news for the clinical lab industry, at least as it pertains to that perennial question: Should hospital lab outreach data be included in a PAMA market study? The federal Centers for Medicare and …
CMS Shows Its Hand in New Draft Rules for 2019
By Joseph Burns | From the Volume XXV No. 11 – July 30, 2018 Issue
CEO SUMMARY: Publication of the draft Medicare Physician Fee Schedule on July 12 brought unwelcome news for the clinical lab industry, at least as it pertains to whether hospital lab outreach data should be included in the PAMA market study that the federal Centers for Medicare and Medica…
NILA: CLIA Proposal Doesn’t Address Flaws
By Joseph Burns | From the Volume XXV No. 3 – February 12, 2018 Issue
CEO SUMMARY: For many years, NILA has urged the federal Centers for Medicare and Medicaid Services to make significant changes in CLIA regulations. Yet, in its recent request for information, CMS addressed five specific areas. But the federal agency left out the need for a comprehensive o…
Lab Executives Declare Concerns about Fee Cuts
By Joseph Burns | From the Volume XXV No. 1 – January 2, 2018 Issue
CEO SUMMARY: Members of Joint Venture Hospital Laboratories in Michigan anticipate that the 2018 Clinical Laboratory Fee Schedule rates being implemented under PAMA will lower payment from Medicare to less than the cost of running tests, especially for rural and critical access hospitals….
CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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