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acla
Labs May Be Excluded from Revised Stark Law, AKS Rules
This is an excerpt of a 1,460-word article in the Jan. 6, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Here are early insights about a federal compliance reform that has not gotten much attention among clinical la…
ACLA Gets Procedural Win in Its Appeal of PAMA Case
By Joseph Burns | From the Volume XXVI No. 11 – August 12, 2019 Issue
IN A SIGNIFICANT WIN for the American Clinical Laboratory Association (ACLA) and other groups suing federal Department of Health and Human Services (HHS), the U.S. Court of Appeals for the District of Columbia ruled in the ACLA’s favor on July 30. Ruling on the ap…
Bill Would Delay PAMA Reporting for One Year
By Joseph Burns | From the Volume XXVI No. 10 – July 22, 2019 Issue
CEO SUMMARY: For all laboratories that must report private payer price data under the Protecting Access to Medicare Act (PAMA), a new bill in congress would delay the next round of data reporting for one year and require the National Academy of Medicine to recommend ways to improve the da…
CMS, Lab Groups Begin Talks About Issues with NCCI Edits
By Joseph Burns | From the Volume XXVI No. 7 – May 20, 2019 Issue
SERIOUS PROBLEMS WITH THE NEW GUIDELINES for the National Correct Coding Initiative (NCCI) that were implemented on Jan. 1 have caused nine clinical laboratory associations and groups to come together and voice their concerns to the federal Centers for Medicare and Medicaid Services…
Labs Get High Denial Rates Under New NCCI Rules
By Joseph Burns | From the Volume XXVI No. 6 – April 29, 2019 Issue
CEO SUMMARY: Under guidelines the National Correct Coding Initiative issued last year, many clinical laboratories are not getting paid for some tests. The rates of denial for labs running mostly molecular tests could range from 40% to 100% of revenue, one billing expert said. Implemented …
ACLA: NCCI Guidelines Are a ‘Step Backwards’
By Joseph Burns | From the Volume XXVI No. 6 – April 29, 2019 Issue
CEO SUMMARY: In a letter to the National Correct Coding Initiative, the American Clinical Laboratory Association (ACLA) raised significant concerns about new language in the policy manuals for Medicare and Medicaid. ACLA said the new NCCI guidelines for molecular and other tests requiring…
COLA: GAO Should Address PAMA’s Effect on Patients
By Joseph Burns | From the Volume XXVI No. 4 – March 18, 2019 Issue
CEO SUMMARY: In a recent statement, COLA, an organization that accredits clinical labs, expressed strong concern about how a report from the Government Accountability Office did not address how the Protecting Access to Medicare Act of 2014 (PAMA) affects patients’ access to testing, esp…
In PAMA Appeal, ACLA Says Federal District Court Erred
By Joseph Burns | From the Volume XXVI No. 1 – January 14, 2019 Issue
LAST MONTH the American Clinical Laboratory Association (ACLA) filed an appeal in its case against the federal Department of Health and Human Services (HHS). In its court filing, the ACLA said that a federal district court judge erred in her ruling against the lab as…
Several Big Surprises in 2018’s Top 10 Lab Stories
By Robert Michel | From the Volume XXV No. 18 – December 24, 2018 Issue
CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laborator…
New Opioid Law Hits Labs Paying Sales Commissions
By Joseph Burns | From the Volume XXV No. 17 – December 3, 2018 Issue
CEO SUMMARY: At the last minute, Congress added all clinical laboratories to a far-reaching anti-kickback provision in the newly-enacted Support for Patients and Communities Act. This provision applies to all payers, both government and private. Lab experts say this new law could have a n…
CURRENT ISSUE

Volume XXX No. 2 – January 23, 2023
The Dark Report explores the decision by The Joint Commission to no longer accept COLA-accredited facilities at its own accredited organizations, and reprints the letters sent by both TJC and COLA relative to the move. In other news, CLIA changes are coming and The Dark Report has an exclusive interview with a member of the committee studying those potential changes.
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