Dec 11, 2013 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory News, Laboratory Pathology, Laboratory Sales and Marketing, Management & Operations
FDA’s assertion of power to regulate genetic tests is a familiar argument to pathologists and clinical laboratory scientists, but does create problems for 23andMe
It has been national news since November 22, when the Food and Drug Administration (FDA) sent a letter to 23andMe ordering it to stop the sale of direct-to-consumer genetic tests. The FDA said that 23andMe had failed to prove the validity of its genetic tests and gave the company 15 days to respond and identify the steps it would take to address FDA concerns.
This event has fulfilled the predictions of many pathologists and clinical laboratory professionals. Having dealt with the FDA throughout their careers, experienced medical laboratory scientists knew that the FDA would eventually take enforcement action against 23andMe, if the company did not provide adequate scientific information to support the clinical validity of its genetic tests. (more…)
Nov 20, 2013 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing
This technique transforms ordinary paper into a biofunctional medium that could support a variety of diagnostic tests and lower the cost of clinical laboratory testing
Is the clinical laboratory profession ready for a diagnostic technology that uses ordinary copy paper as the foundation for applying the reagents needed to run any number of fast, portable, accurate, and cheap medical laboratory assays? A recent technology breakthrough may make this possible in just a few years.
A bioengineering team at the University of Washington (UWA) has developed a method to stick medically interesting molecules to ordinary copy machine paper. This “chemical trick” opens the door to developing all sorts of paper-based diagnostic tests that are not just cheap, but virtually free, noted a report published by Fierce Medical Devices. (more…)
Nov 8, 2013 | Coding, Billing, and Collections, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing
The end of fee-for-service payments has huge implications for U.S. medical laboratories and anatomic pathology practices
SAN DIEGO, CALIFORNIA—In the American healthcare system today, the era of fee-for-service medicine will soon end. This development has huge implications for every clinical laboratory and anatomic pathology practice in the United States because fee-for-service is their primary source of revenue.
This week at the 2013 Annual Conference of the California Clinical Laboratory Association (CCLA), no single topic got more attention than that of reimbursement for clinical laboratory tests and anatomic pathology services. (more…)
Nov 1, 2013 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Managed Care Contracts & Payer Reimbursement, Management & Operations
In September UnitedHealthcare and its collaborators announced plans to create what is planned to be one of the largest accountable care organizations in Wisconsin
As predicted, national health insurance companies are moving deliberately to be part of large accountable care organizations (ACOs). For example, in Wisconsin, three health systems and one of the nation’s largest health insurers are developing a multi-system accountable care organization designed to compete with the largest ACO in the state.
ACOs Expected to Use Medical Laboratory Testing in Different Ways
For pathologists and clinical laboratory executives, this development is a reminder that ACOs will play a significant role in healthcare’s transformation. Also, these super-sized ACOs will have their own influence on the transformation of medical laboratory testing in this country, since ACOs can be expected to use medical laboratory testing in different ways and are unlikely to use fee-for-service as the primary method of payment for laboratory testing.
In September when UnitedHealthcare (UHC) (NYSE: UNH) announced it was collaborating with two health systems to form an ACO in Wisconsin to cover 100,000 patients. A third health system (Ministry Health) joined the new ACO network a week later. UHC efforts are part of a nationwide strategy to double what it spends to provide care in ACOs. (more…)
Oct 21, 2013 | Coding, Billing, and Collections, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Management & Operations
Tracking specimen collections online is a significant benefit because clinical laboratories can track specimens in real time from pick-up to arrival in the laboratory
At a time when delivering added value to physician clients is a key differentiator for any clinical laboratory wanting to build market share and increase specimen volume, having the right courier and logistics solution can mean the difference between financial success and failure.
Experienced pathologists and medical laboratory managers know why. Every day, the lab courier who shows up at the client’s office is often the primary personal contact between that physician’s office and the lab. Problems with a lab’s courier services are an all-too-common reason why a client switches to a competing laboratory. (more…)
Oct 16, 2013 | Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Sales and Marketing, Management & Operations
Recent hospital mergers are creating super-sized health systems that immediately gain leverage over insurers when negotiating managed care contracts
Experts say the nation is experiencing its biggest surge in hospital mergers in more than a decade. Moreover, this latest wave of deals is creating supersized hospital systems that are expected to dominate healthcare and possibly lead to higher healthcare costs.
The ongoing consolidation of hospital ownership means further consolidation of the hospital laboratories that find themselves merged into larger health systems. That will have both good and bad consequences for pathologists and medical laboratory managers working within these organizations. (more…)
