D.C. Circuit Court Reverses Medical Necessity Ruling

By Joseph Burns | From the Volume XXV No. 5 – March 26, 2018 Issue

MANY LAB EXECUTIVES were concerned last year after a judge in the District of Columbia Circuit Court ruled that clinical laboratories need to determine that all lab test services physicians order are medically necessary. The court also ruled that ordering physicians do not need to determine medical …

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Attorney Jane Pine Wood to Be Chief Legal Counsel at Bio-Reference

By Robert Michel | From the Volume XXIII No. 13 – September 26, 2016 Issue

One of the most widely-respected and trusted attorneys serving the clinical laboratory industry and anatomic pathology profession is leaving private practice to join the corporate world. …

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CMS CLIA Sanction Letter Sent To Theranos Raises Questions

By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue

CITING PRACTICES THAT JEOPARDIZE PATIENT SAFETY, the federal Centers for Medicare & Medicaid Services decided earlier this month to revoke the CLIA certificate that it granted to Theranos Inc. to operate a clinical laboratory in Newark, Calif., and to ban the lab…

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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 …

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What Labs Need to Do as Payers Audit More Claims

By Joseph Burns | From the Volume XXII NO. 7 – May 11, 2015 Issue

CEO SUMMARY: Attorneys who advise pathologists and clinical laboratories on compliance issues say the number of audits from the government and third-party payers has increased sharply in recent years. In those audits, payers are looking for recoupment of overpayments. A lab’s fai…

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Attorneys Outline Issues in FDA’s LDT Guidance

By Joseph Burns | From the Volume XXI No.16 – November 24, 2014 Issue

CEO SUMMARY: Officials at the FDA believe that CLIA does not go far enough because it does not address the issues of whether laboratory-developed tests (LDTs) have been designed correctly or have been manufactured in accordance with sound standards. Also, CLIA does not include a process to verify…

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Public Comment Started on FDA LDT Regulations

By Joseph Burns | From the Volume XXI No. 15 – November 3, 2014 Issue

CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…

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September 02, 2014 “Intelligence: Late- Breaking News”

By Robert Michel | From the Volume XXI No. 12 – September 2, 2014 Issue

There will be one less vendor of laboratory information systems (LIS) when a major acquisition is completed. Last month, Siemens AG announced that it would sell Siemens Health Services to Cerner Corp. for a price of $1.3 billion. Analysts believe tha…

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Experts Say Labs May Start to Receive MDx Payments

By Joseph Burns | From the Volume XX No. 5 – April 15, 2013 Issue

CEO SUMMARY: In the fourth month of the current year, there is plenty of confusion and uncertainty over how the Medicare program will establish prices for the new molecular CPT codes and when both government and private payers will begin to regularly reimburse laboratorie…

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Lawyers Share Insights about ACO Contracting

By Joseph Burns | From the Volume XX No. 2 February 11, 2013 Issue

CEO SUMMARY: Most pathologists have yet to be involved in any substantial contractual negotiations that would allow them to assume a significant role in accountable care organizations (ACOs). Instead, hospitals and health systems are putting the building blocks in place by acquiring physi…

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