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HHS

January 10, 2022 Intelligence: Late-Breaking Lab News

Imagine a medical lab temporarily closing because of the demand for too many tests! That’s just what happened at one of Australia’s largest medical lab companies. Australian Clinical Labs had to temporarily discontinue offering COVID-19 testing because test volumes had gotten too large. Au…

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2021’s Top 10 Lab Stories Highlight Important Trends

This is an excerpt of a 3,075-word article in the December 20, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab stories for 2021. Beyond…

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2021’s Top 10 Lab Stories Confirm Important Trends

CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab industry stories for 2021. Beyond COVID-19 testing, the virus crept its way into long-term trends, such as pathology jobs and technology innovation. New ways of delivering healthcare will need respons…

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Florida Laboratory Owner Gets 82-Month Jail Term

CEO SUMMARY: Federal prosecutors are sending a clinical lab owner to federal prison for almost eight years. Hopefully, this is a sign that the Department of Justice (DOJ) is ready to use criminal indictments more frequently against lab owners, lab managers, and lab sales reps who vi…

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Federal Rule to Revise Out-of-Network Billing

CEO SUMMARY: Remaining out of network with health insurance companies may boost revenue for providers, including anatomic pathologists and emergency room physicians. But the good times may soon end. Last month four federal agencies issued rules that implement new requirements under …

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New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings

CEO SUMMARY: Our second installment in this series describes an emerging new clas…

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Comment Period Closing on Federal Surprise Billing Rule

PATHOLOGY GROUPS AND CLINICAL LABS HAD UNTIL SEPTEMBER 7 to comment on an interim final rule that provides federal protections against surprise billing and limits out-of-network (OON) cost sharing under many of the circumstances in which surprise bills arise most frequently….

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Insurers Get Aggressive with Years-Old Audits, Searching for Lab Overpayments

This is an excerpt of a 1,971-word article in the July 26, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Not only are health insurers looking back to find lab overpayments and funds paid erroneously, but…

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Insurers Get Aggressive with Years-Old Audits

CEO SUMMARY: Not only are health insurers looking back to find overpayments and funds paid erroneously, but payers also are requiring documentation for overpayments. If clinical labs and anatomic pathology groups do not appeal such claims quickly, they may be liable for any amount i…

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New Twist: HHS Exerts Authority Over FDA on LDTs

CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…

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