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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
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
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
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…
ACLA: NCCI Guidelines Are a ‘Step Backwards’
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…
Labs Get High Denial Rates Under New NCCI Rules
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 …
COLA: GAO Should Address PAMA’s Effect on Patients
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
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
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…
Attorney Explains Risks from New ‘Support Act’
CEO SUMMARY: Legislation signed into law on Oct. 24 was designed to stem the nation’s opioid crisis. But in addition to applying to sober homes and addiction treatment centers, the law also applies to clinical laboratories. Called the ‘Support for Patients and Communities Act,’ the …
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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