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

The Protecting Access to Medicare Act (PAMA) includes the most extensive reform of the Medicare Clinical Laboratory Fee Schedule (CLFS) since it was established in 1984. Signed into law on April 1, 2014, PAMA was intended to introduce market-based pricing to the Medicare CLFS.  PAMA was passed after it was discovered by the Health and Human Services’ Office of Inspector General (OIG) that Medicare paid significantly more for clinical laboratory tests than commercial payers, and in some cases, Medicaid1. 

by BRANDON MCCUTCHEON, MD

If you are a physician or know a physician or have ever visited one, chances are you have probably heard them complain about technology in health care. More to the point, they are likely to be complaining about the one piece of technology that affects their lives minute-to-minute: the electronic health record (EHR). To get a sense of how central EHRs are to our daily routines, consider that physicians now spend more time in the EHR than they do seeing patients (6 hours of an average 11-hour work day). And while it is easy to write them off as luddites unable to adapt to new technology, an important study by the RAND organization noted that physicians approve of EHRs in principle and see the potential for the technology to improve the delivery of clinical care.

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.