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by DYLAN J. CHADWICK

In a changing medical landscape, physicians willing to invest in their practices are the ones who'll succeed. Though evolving technology and its subsequent improvements in patient care have brought substantial changes to the medical sector, an era of economic uncertainty and fiscal instability may wring just as prescient an effect. According to an article by Ben Brown, MD, reductions in Medicare contract payments (some as much as 21.3%) and physician reimbursements from insurers might result in critical decreases in physician salaries, medical profits and general revenue for a practice. What proves even more concerning for physicians and patients alike, is a present medical landscape of high healthcare costs, an ever-increasing need for healthcare options and diminishing resources. Furthermore, caring physicians want to be effective providers for their patients, but they also want the appreciation and financial compensation for their profession demands.

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

There may be circumstances when laboratories consider the option to modify an FDA-cleared or approved test system. These may be due to the specific needs of the population served, or based on cost/benefit analyses of instrumentation and reagent use; or based on the logistics of in-house testing capabilities.  CLIA allows clinical laboratories to modify their FDA-approved tests, and even to develop their own tests, known as laboratory-developed tests (LDTs), as long as they follow the requirements to validate the performance characteristics of their modified or in-house developed tests.