TAG:
lab industry
Labs Have Heavy Burden to Report Lab Price Data
By Joseph Burns | From the Volume XXIII No. 15 – November 7, 2016 Issue
CEO SUMMARY: Clinical labs must assess their responsibilities to report lab test market prices to CMS as part of the Protecting Access to Medicare Act. A panel of three experts took up this topic at a recent webinar hosted by THE DARK REPORT. On June 23, the federal Centers for Medicaid &…
10% PAMA Fee Cut Would Lower Medicare Pay to Laboratories by $400 Million
By Joseph Burns | From the Volume XXIII No. 15 – November 7, 2016 Issue
CEO SUMMARY: Just eight weeks remain before certain clinical laboratories must begin submitting private payer lab test price data to the federal Centers for Medicare & Medicaid Services. A new report …
Medicare Part B Lab Test Prices Versus Budgeted Payment
By R. Lewis Dark | From the Volume XXIII No. 15 – November 7, 2016 Issue
THERE IS AN IMPORTANT QUESTION THAT lab industry magazines and news sources have failed to address: How many years are left before Medicare officials drop fee-for-service payment for clinical lab testing? On January 26, 2015, the Department of Health and Human Services (HHS) issued a press rele…
Theranos Ends Patient Testing, Sued for Deceiving Investors
By Joseph Burns | From the Volume XXIII No. 14 – October 17, 2016 Issue
IN THE EARLY 1960S, the great bluesman Albert King wrote, “Born Under a Bad Sign,” which contained the unforgettable lyric, “If it wasn’t for bad luck, I wouldn’t have no luck at all.” That lyric almost describes what’s happened to Theranos Inc. since October 2015. Al…
FDA Official Outlines Need for Federal Regulation of LDTs
By Robert Michel | From the Volume XXIII No. 14 – October 17, 2016 Issue
AT A CONGRESSIONAL BRIEFING LAST WEEK, a federal official charged with regulating laboratory-developed tests made the case that LDTs are inconsistently reliable and thus put patients at risk, according to MedPage Today. “If you take the same patient sample and you send it to different la…
Can Clinical Laboratories Adjust To ‘New’ Healthcare System?
By Robert Michel | From the Volume XXIII No. 14 – October 17, 2016 Issue
CEO SUMMARY: Month by month, there is increased clarity in the path the American healthcare system will follow as hospitals, health systems, and physicians integrate clinical care, manage populations, and practice personalized and precision medicine. While these changes play out, clinical…
Health Diagnostics Laboratory lawsuit seeks $600M; will it establish a new precedent?
By Mary Van Doren | From the Volume XXIII No. 13 – September 26, 2016 Issue
This is an excerpt from a 1,350-word article in the September 26 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: It’…
Labs Caught Between Employer Hammer, Payer Anvil
By R. Lewis Dark | From the Volume XXIII No. 12 – September 6, 2016 Issue
STARTING ON JANUARY 1, 2017, THE CLINICAL LABORATORY INDUSTRY will undergo a new experiment in price-setting (and price-cutting) by the federal Centers for Medicare & Medicaid Services. On that date, certain labs must begin reporting market price data for each test and each payer…
Alert to All Labs: Beware Of ‘Reference Pricing’
By Robert Michel | From the Volume XXIII No. 12 – September 6, 2016 Issue
CEO SUMMARY: “Reference pricing” does not refer to how a lab negotiates prices with its reference lab! Rather, reference pricing describes a specific approach to health plan benefits that incentivizes the consumer to choose lower-cost providers while allowing that consumer to still us…
Reference Pricing’s New Lab Winners and Losers
By Robert Michel | From the Volume XXIII No. 12 – September 6, 2016 Issue
CEO SUMMARY: Expanded use of reference pricing by employers in coming years could trigger a cycle of cuts to lab test prices that would put the most pressure on the lab companies with the highest prices. Many hospital labs are viewed as having high prices. But because they run outreach sp…
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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