News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Medical Device Companies May Pass New 2.3% Federal Excise Tax Along to Healthcare Providers, Including Clinical Pathology Laboratories

Lots of controversy is associated with this new tax levy that was mandated by the Affordable Care Act

Will it be medical device manufacturers or their customers—including medical laboratories—who pay the new 2.3% medical device tax that became effective on January 1, 2013? That question is being asked by healthcare policymakers and experts, as well as pathologists and clinical laboratory administrators.

This new tax is mandated by the Affordable Care Act on medical device sales to healthcare providers. It taxes gross receipts of more than $5 million for manufacturers and importers of medical devices and is unpopular within the medical device industry, including in vitro diagnostics (IVD) manufacturers. (more…)

FDA Issues Proposed Rule on Medical Device UDI System That Will Also Apply to Clinical Pathology Analyzers and Lab Products

Many products that medical laboratories use will be covered under the new UDI system

You’re reading it here first! UPCs—universal product codes—are coming soon to the medical laboratory analyzers and other products that your clinical laboratory purchases. Under a proposed rule published by the Food and Drug Administration (FDA), medical devices will soon have UDIs—universal device identifiers.

You know about UPCs. Those are the ubiquitous “universal product codes” that are found on literally every retail product. UPCs make scanning at the cash register possible. Now a similar system is coming to medical devices, including the lab analyzers, reagents, and other products used by medical laboratories and pathology. (more…)

Medical Device Manufacturers Association (MDMA) Claims Hospitals and Clinical Laboratories Don’t Get Best Pricing from GPO Contracts

Researchers Offer Evidence that Hospitals and Pathology Labs Often Negotiate Lower Prices on Their Own


Even as Congress shines a spotlight on the business activities of group purchasing organizations (GPOs), the Medical Device Manufacturers Association (MDMA) has made public a research study it initiated about GPO contract practices. This report says an inherent conflict of interest prevents GPOs from obtaining the lowest possible prices for its hospital and clinical pathology laboratory members.

On December 3rd, Dark Daily reported on the report published by the General Accountability Office (GAO) in response to a Congressional directive. The GAO determined that, during 2008, sales made under GPO contracts by members, including hospitals, clinical laboratories, and other types of healthcare providers, totaled $109 billion.

The six GPOs studied by the GAO earned a bit more than $2 billion in revenue for 2008. Of this, $1.7 billion came from administrative fees generated by contract purchases. The balance of $320 million was from fees generated by supply chain outsources, revenue cycle management, and consulting.

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Do GPOs Help Hospitals and Clinical Laboratories Save Money? GAO Report Answers That Question

GAO investigates certain business practices of group purchasing organizations


For years, hospitals and clinical pathology laboratories have wondered exactly how much money is saved when they use the services of group purchasing organizations (GPOs). Now a newly-published government report provides interesting details about the financial activities of GPOs.

In response to a Congressional directive, the Government Accountability Office (GAO) recently studied GPOs and released a report on their findings. The GAO’s report will be of particular interest for pathologists and medical laboratory managers working in hospital laboratories.

GAO Report Looks at GPO Activities in 2008

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Global Location Numbers (GLNs) Soon to Be Used by Clinical Pathology Laboratories

Uniform tracking standard will revolutionize healthcare purchasing nationwide


Most pathologists and clinical laboratory managers are not aware that implementation of global location numbers (GLNs) will occur in just a few months. Every healthcare provider in the United States and many other nations will get a unique GLN.

The entire purchasing and shipping side of healthcare is poised to adopt a universal standard that will ensure the precise delivery of products to their final destinations. Clinical laboratories and anatomic pathology groups will no longer experience delays caused by lost or incorrectly delivered supplies. At least that’s the hope of most of the nation’s major group purchasing organizations (GPO).

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