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Labs React with Criticism to Proposed ADLT Rule
By Joseph Burns | From the Volume XXII No. 15 – October 26, 2015 Issue
CEO SUMMARY: Some in the lab industry had high hopes that passage of the Protecting Access to Medicare Act (PAMA) last year would favorably resolve a number of important issues. However, those hopes were dashed following the September 25 release by CMS of a proposed rule setting out how i…
June 1, 2015 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXII NO. 8 – June 1, 2015 Issue
It’s a laboratory acquisition that is worth US$1.3 billion. In Europe, Cinven, a pri ate equity company, will acquire Labco SA of Paris, France. Labco operates medical laboratories in France, Spain, Italy, Portugal, Belgium, and the United Kingdom. It reports annual revenue of US$714 mi…
New Pricing Formula for Advanced Diagnostic Tests
By R. Lewis Dark | From the Volume XXI NO. 6 – April 28, 2014 Issue
CEO SUMMARY: One section of the federal H.R. 4302: Protecting Access to Medicare Act of 2014 is getting positive reviews from many lab experts. The law defines advanced diagnostic tests (ADTs) and directs CMS to assign a temporary HCPCS code and use list prices to pay labs for such tests …
Lab’s Patient-Centric Approach Collects Overdue Money in PSCs
By Joseph Burns | From the Volume XX, No. 16 – December 2, 2013 Issue
CEO SUMMARY: At Sonora Quest Laboratories (SQL), the ‘Voice of the Customer’ is guiding the organization’s evolution from physician-centric to patient-centric. It was quickly recognized that an effective enterprise master patient index (EMPI) was essential. One patient-centric servi…
September 9, 2013 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XX No. 12 – September 9, 2013 Issue
bioMérieux is on the move. Last week it announced that it would pay $450 million to purchase privately-held BioFire Diagnostics of Salt Lake City, Utah. BioFire has a solid tech- nology base in molecular diagnostics. It developed and currently markets its FilmArray…
Labs Have New Hurdles as Some Payments Start
By Joseph Burns | From the Volume XX No. 8 – June 17, 2013 Issue
CEO SUMMARY: Some payments are beginning to flow for claims submitted under the new molecular test CPT codes. But there is a new issue. Medicare contractors, Medicaid programs, and private health insurers are deeming certain molecular tests to be medically unnecessary. Th…
Much Uncertainty About Pay for Molecular Codes
By Joseph Burns | From the Volume XX No. 7 – May 28, 2013 Issue
CEO SUMMARY: Having gone unpaid since January 1 for the 114 new molecular CPT codes, many clinical labs and pathology groups have stopped running these tests or laid off staff. Some are considering closing their doors. Evidence indicates that certain Medicare contractors are deciding that…
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…
Medicare Taken to Task about Molecular Test Pricing Method
By Robert Michel | From the Volume XX No. 5 – April 15, 2013 Issue
EDITOR’S NOTE: Submitted by Lâle White, CEO of XIFIN, Inc., of Carlsbad, California, this letter describes the problems caused by the Medicare program’s failure, as of January 1, 2013, to be ready to process and reimburse lab test claims for more than 100 new mo…
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…
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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