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 necessity, noted the law firm McDonald Hopkins in a
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.
Effective October 1, 2016, Jane Pine Wood becomes the new Chief Legal Counsel and Compliance Officer for Bio-Reference Laboratories, Inc., of Elmwood Park, New Jersey. Wood will leave McDonald Hopkins, based in
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 company’s founder and CEO Elizabeth Holmes from the operating a clinical laboratory for
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 Executive War College on Lab and Pathology Management, expert speakers will address how
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 failure to provide proper documentation during these audits can result in the need to pay sixand seven-figure amounts. Payers also are auditing out-of-network billing and patient balance billing.
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 if LDTs are safe, accurate, or efficacious,
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 bureaucratic oversight of LDTs. The FDA said that this new layer of regulation will be phased
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 that Cerner was motivated to do the deal because, among other benefits, it would gain
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 laboratories. As of this date, even lab billing experts and lawyers are
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 physician practices and installing the necessary infrastructure that their ACOs will need to