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national independent laboratory association
Labs Ask: Does PAMA Statute Prevent Legal Challenges?
By Joseph Burns | From the Volume XXIV No. 4 – March 13, 2017 Issue
SINCE MEDICARE OFFICIALS PUBLISHED the final rule for lab test market price reporting of private payer prices last year, clinical lab industry consultants and lawyers have raised serious criticisms of the rule. The critics recognized that CMS officials wrote a final rule for the Protecting Access to…
PAMA Reporting Penalties Can Be Substantial for Laboratories
By Joseph Burns | From the Volume XXIII, No. 17 – December 19, 2016 Issue
STARTING JAN. 1, 2017, there are substantial penalties for labs that fail to properly meet the complex lab test price marketing reporting requirements of the Protecting Access to Medicare Act of 2014. Labs that fail to do so face the potential of stiff, multi-million dollar fines. “Under PAMA, cli…
Labs Discover Much Complexity In Their Lab Test Price Data
By Joseph Burns | From the Volume XXIII No. 16 – November 28, 2016 Issue
DON’T EXPECT IT TO BE EASY AND STRAIGHTFORWARD when reporting the prices of chemistry panels as the final rule for lab test market price reporting rule requires. Instead, labs should expect the process to be complex and troublesome. Also, labs should be concerned that Medicare officials have threa…
California’s Lab Price Data Collection Project Cuts Lab Test Prices by 10.5%
By Joseph Burns | From the Volume XXIII No. 16 – November 28, 2016 Issue
COLLECTING LAB TEST PRICE DATA is not limited to PAMA and the federal Centers for Medicare & Medicaid Services. California’s Medi-Cal program is in its second year of requiring clinical labs to submit private payer lab test price data. However, in both the fir…
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 &…
PAMA Final Rule Issued, CMS Plans to Cut Rates by 5.6%
By Joseph Burns | From the Volume XXIII No. 9 – July 5, 2016 Issue
CEO SUMMARY: CMS issued its final rule for implementing the laboratory payment reform included in the Protecting Access to Medicare Act of 2014 (PAMA) on June 17. All labs will see significant reductions to the Medicare Part B Clinical Laboratory Fee Schedule that becomes effective on Jan…
PAMA Final Rule a Threat To Community Lab Survival
By Joseph Burns | From the Volume XXIII No. 9 – July 5, 2016 Issue
CEO SUMMARY: Will implementation of the final PAMA private payment rate reporting rule for labs put smaller, community labs at financial risk? Yes, says the National Independent Laboratory Association (NILA). By deliberately setting a standard to exclude private payer payment data from ho…
New Threat To Community Lab Survival: CMS Clinical Lab Fee Schedule Cuts
By Mary Van Doren | From the Volume XXIII No. 9 – July 5, 2016 Issue
This is an excerpt from a 2,000-word article in the July 5 issue of THE DARK REPORT. The original article is available to paid members of the Dark Intelligence Group. CEO SUMMARY: Everyone has read the basic facts, but THE DARK REPORT has gone further …
Understanding the Future Of Laboratory Medicine
By Robert Michel | From the Volume XXIII No. 4 – March 21, 2016 Issue
CEO SUMMARY: Healthcare’s transformation is now far enough along that most clinical labs and pathology groups are either feeling the financial pain or are excitedly developing ways to deliver more value from lab testing services. On April 26-27, at the 21st annual …
Labs Have Questions for CMS on Proposed Rule
By Joseph Burns | From the Volume XXII No. 14 – October 5, 2015 Issue
CEO SUMMARY: On September 25, CMS took a long overdue step to issue a proposed rule on how medical laboratories are to report private market prices for lab tests to the Medicare program during 2016. The proposed rule provides insights as to how CMS envisions pricing new tests and advanced…
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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