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clinical laboratory industry
CMS’ Proposed Lab Rules May Not Fly with Congress
By Joseph Burns | From the Volume XX No. 12 – September 9, 2013 Issue
CEO SUMMARY: Many clinical lab administrators have noticed the new activism at the federal Centers for Medicare Medicaid Services (CMS) when it comes to control of establishing prices for clinical laboratory tests. In this exclusive interview, two long-time advocates for the National Inde…
Medicare Contractor’s Ruling on MolDx Test Causes Lab to Close
By Joseph Burns | From the Volume XX No. 9 – July 8, 2013 Issue
CEO SUMMARY: On May 14, Predictive Biosciences learned that its Medicare contractor had determined that one of its three molecular tests for bladder cancer was a screening test. It also never got a determination on its other two molecular tests. Because Medicare is half of the lab’s pay…
OIG Tells CMS It Could Save $910 Million on Lab Test Costs
By Robert Michel | From the Volume XX No. 8 – June 17, 2013 Issue
IT IS ONE MORE POWERFUL SIGN of the changing times. Last week, the Office of the Inspector (OIG) publicly released a study it had done of the prices paid for lab testing and how the Medicare program could use this information to reduce the cost of Part B clinical laboratory testing. It was The W…
How CMS ‘Mismanaged’ Pricing of Molecular Tests
By Joseph Burns | From the Volume XX No. 5 – April 15, 2013 Issue
CEO SUMMARY: CMS and its contractors had ample opportunity to implement a new reimbursement system but failed to act in a timely manner, stated an expert familiar with the problem. The result is that laboratories, particularly those that have one or two proprietary molecular tests, are be…
Low 2013 Molecular Rates May Bankrupt Some Labs
By R. Lewis Dark | From the Volume XX No. 2 February 11, 2013 Issue
CEO SUMMARY: Many of the recently issued reimbursement rates for molecular diagnostic tests are inadequate and in fact are lower than the cost of running the tests, lab experts say. Smaller laboratories that specialize in developing and selling molecular tests could be forced to close. As…
2012’s Top Ten Lab Stories Predict More Challenges
By Robert Michel | From the Volume XIX No. 18 – December 31, 2012 Issue
CEO SUMMARY: It’s been a year with more lows than highs, when viewed through the lens of THE DARK REPORT’S “Top Ten Lab Stories of 2012.” The end of the TC grandfather clause, new policies for prostate biopsy billing, and a dramatic 52% cut to 88305- TC fees were widely reported. …
More Medicare Auditors Are Targeting Clinical Labs
By Joseph Burns | From the Volume XIX No. 16 – November 19, 2012 Issue
CEO SUMMARY: For labs and all healthcare providers, the risk of an audit is growing because the number of auditors seeking overpayments is rising. In their efforts to eliminate waste and make the Medicare and state Medicaid programs more efficient, federal officials have introduced severa…
NY Hospital Closed Due to Deficiencies in Lab
By Robert Michel | From the Volume XIX No. 15 – October 29, 2012 Issue
CEO SUMMARY: Lab executives and pathologists have long read about the deteriorating finances at many rural hospitals, along with their struggles to recruit and retain enough skilled laboratory staff. Now the closure of the laboratory at 37-bed E.J. Noble Hospital in Gouverneur, N…
Alan Lloyd, 62, Dies of Cancer, Formerly CIO of Sonic Health
By Robert Michel | From the Volume XIX No. 15 – October 29, 2012 Issue
THIS SUMMER, the global clinical laboratory industry lost a true innovator in medical laboratory management, operations, and informatics. On August 8, 2012, Dr. Alan Lloyd died peacefully at home from pancreatic cancer. Lloyd was widely-respected for his unique approaches to laboratory operations, l…
CDC Surveys Docs’ Use of Laboratory Test Results
By Joseph Burns | From the Volume XIX No. – October 8, 2012 Issue
CEO SUMMARY: There’s a treasure trove of information and insights about how physicians use clinical laboratory tests contained in survey data recently collected by a team from the Centers for Disease Control and Prevention. Designed to identify challenges in how physicians utilize labor…
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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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