Apr 13, 2015 | Compliance, Legal, and Malpractice, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Under the DOJ’s settlement agreement, HDL may need to pay as much as $100 million, according to a published report
Health Diagnostics Laboratory Inc. (HDL), of Richmond, Virginia, and Singulex Inc., of Alameda, California, agreed to pay $48.5 million to settle charges that they violated the False Claims Act, the Department of Justice (DOJ) announced Thursday.
According to the DOJ, the labs violated the Anti-Kickback Statute by paying physicians in exchange for patient referrals, in addition to billing federal health care programs for medically unnecessary testing. Pathologists, medical laboratory scientists, and clinical laboratory directors have watched this case closely since it became public knowledge last fall.
Other Clinical Laboratories and Lab Executives Face Federal Lawsuits (more…)
Apr 8, 2015 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Additional studies are needed before medical laboratory tests for ‘lean’ microbes can be developed for use by physicians treating overweight and obese patients
Researchers at Cornell University have identified a family of microbes that may provide a genetic explanation for why some people are able to stay thin. If their findings are validated, a clinical laboratory test for these bacteria, and a macrobotic regiment to help people lose weight or stay lean, could be down the road.
Emerging Field Involving the Human Microbiome
The Cornell study was published in November 2014 in the journal Cell. It spotlights one bacterial taxon, the family Christensenellaceae, which was only named in 2012. That makes it a relatively new subject for researchers in the booming human microbiome sector.
Ruth Ley, Ph.D., is a Cornell University Associate Professor of Microbiology, and the research paper’s senior author. She believes the new Cornell study makes clear the connection between the human genotype and health-associated gut bacteria. (more…)
Apr 6, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
However, China has a shortage of well-trained pathologists, which is why some American lab organizations are establishing medical lab testing ventures in China
If experts are right, a company in China is poised to become the world’s largest at gene sequencing. In addition, the huge volume of genetic data it generates is expected to give this company the world’s largest database of genetic information.
Such developments could mean that, in just a few years, many pathologists and molecular Ph.D.s in the United States will be accessing this trove of genetic data as they conduct research to identify new biomarkers or work with clinical specimens.
The company at the center of all this attention is genome-sequencing giant BGI, located in Shenzhen, China. It owns 230 of the largest, high-throughput gene-sequencing machines and wants to become the world’s largest genome-mapping company. (more…)
Apr 1, 2015 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Alternative payment models and value-based payment schemes create financial unknowns for clinical laboratories and anatomic pathology groups
What happens to pathologists and clinical laboratories when fee-for-service reimbursement ceases to be the primary payment method for anatomic pathology services and medical laboratory tests?
After all, fee-for-service reimbursement for lab tests is what underpins today’s financial model for lab test services. Under this transaction-based business arrangement, a clinical laboratory that can increase its specimen volume will realize a lower average cost-per-test because of economies of scale within the lab. At the same time, the lower costs mean a bigger net margin available from profit, given the fixed price of the reimbursement for lab tests.
So what is a medical laboratory to do as healthcare shifts to a value-based reimbursement (VBR) model, formerly known as pay-for-performance? The answer to that question won’t take long to answer because of a recent announcement by the Department of Health and Human Services (HHS). (more…)
Mar 30, 2015 | Instruments & Equipment, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Innovative clinical laboratories are not only rethinking traditional LIS-to-EHR interfaces with their client physicians, but they are also helping to streamline physicians’ workflow
Most clinical laboratories and anatomic pathology groups would welcome a fast (“easy-on”), cheap, and effective method that enables electronic lab test ordering and lab test reporting between physician’s offices and medical laboratories.
The goal is to create the seamless interface between the electronic health record (EHR) systems of office-based physicians and the laboratory information systems (LIS) of clinical laboratories. Labs want a way to electronically receive lab test orders from physicians in a format that is easily digested by the lab’s LIS, and perhaps their hospital’s information system (HIS), and which also allows the lab to match the orders accurately and seamlessly with specimens as they arrive.
Next, the clinical lab needs an equally seamless way to electronically transmit the medical laboratory test results back to physicians so that this lab test data automatically and accurately populates the physicians’ EHRs. (more…)
Mar 27, 2015 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Hiring & Human Resources, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations, News From Dark Daily
Even federal agencies are feeling the consequences of increased transparency as studies uncover serious problems in how data from clinical trials is made available to the public
Increased transparency is coming to clinical trials because of proposed new federal rules. Although the greatest impact will be on drug trials and pharmaceutical research, experts believe that developers of new diagnostic technologies and clinical laboratory tests will benefit as a result of easier access to the public data filed by researchers. Two government agencies published notices announcing their intention to stiffen requirements for greater transparency in clinical trials. The proposed changes are significant for pathologists and medical laboratory professionals because, more stringent requirements for registration and dissemination would make more data from clinical studies available for researchers who develop clinical laboratory tests.
HHS and NIH Publish Notice of Proposed Changes
In November 2014, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM). The same month, its research agency, the National Institutes of Health, announced a draft policy regarding required dissemination of NIH-funded clinical trial information.
The goal of the proposed changes is to ensure that summary results for drugs that fail in trials, or are dropped for other reasons, still make it into the public database, ClinicalTrials.gov, according to a story published in Science.
(more…)
