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Payers Bolix MDx Codes, Labs Unpaid for Months
By Joseph Burns | From the Volume XX No. 5 – April 15, 2013 Issue
CEO SUMMARY: Clinical laboratories complain that implementation of a new payment system for molecular tests has been a disaster since January 1. Most contractors for the federal Centers for Medicare & Medicaid Services have not paid labs for molecular tests billed thi…
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…
April 15, 2013 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XX No. 5 – April 15, 2013 Issue
Geisinger Health System broke ground last month on construction of a new $52 million medical laboratory facility. It will be 115,000 square feet and will be located at the site of the Geisinger Medical Center in Danville, Pennsylvania. LAB COMPANY COMPLET…
Anticipating Washington’s Next Blows to Lab Testing
By Robert Michel | From the Volume XX No. 4 – March 25, 2013 Issue
CEO SUMMARY: With the advent of 2013, almost every lab was responding to some type of price cut. Clinical labs are dealing with the sequential, multi-year cuts to the Medicare Part B Lab Test Price Schedule. Anatomic pathology labs are still adjusting to the expiration of the TC Grandfath…
Urologists Weigh in on Prostate Biopsy Testing
By Joseph Burns | From the Volume XX No. 3 – March 4, 2013 Issue
CEO SUMMARY: Based on an impressive number of 4,230,129 vials collected from 437,937 biopsies, the new study is expected to add fuel to the fire of the ongoing debate about the appropriate number of prostate biopsies physicians should collect and refer to pathology labs for cancer testing…
Palmetto’s Prostate Biopsy Policy Removed after Talks with CMS
By Robert Michel | From the Volume XX No. 3 – March 4, 2013 Issue
THERE IS SOME POSITIVE LAB INDUSTRY NEWS that has not been widely reported yet. It involves a decision to change an unwelcome Medicare policy that limited the number of prostate biopsy specimens per case that would be reimbursed. After discussions between lab industry groups and the federal …
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…
PAML, Pathology and New Opportunities
By R. Lewis Dark | From the Volume XIX No. 17 – December 10, 2012 Issue
BY ANY MEASURE, MAJOR CHANGES ARE COMING to the profession of laboratory medicine. I assume that you are familiar with most of the trends, healthcare reforms, and significant reductions in lab test reimbursement that appear regularly in the headlines. Many of these developments are unfavorable to th…
Congress May Respond to Tough CLIA PT Penalties
By Joseph Burns | From the Volume XIX No. 11 – August 6, 2012 Issue
CEO SUMMARY: For years, severe penalties in cases where a laboratory has inadvertently erred in handling proficiency testing (PT) specimens have been a point of contention between the Centers for Medicare & Medicaid Services (CMS) and the clinical laboratory profession. Two bills prop…
New BlueCard Policies Affect Lab Test Claims
By Joseph Burns | From the Volume XIX No. 10 – July 16, 2012 Issue
CEO SUMMARY: This new policy from the Blue Cross and Blue Shield Association (BCBSA) becomes effective on October 14, 2012. No longer can a local lab provide service to a member under the BlueCard program and be paid by the local plan in the region where the service was provided….
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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