Sometime next month, FDA will publish a framework for the regulation of laboratory-developed tests, bringing an end to the agency’s long-held policy of “enforcement discretion.”
The word from companies on the exhibit floor at the 2014 meeting of the American Association for Clinical Chemistry turns out to be pretty interesting.
Although enacted primarily as the annual “doc fix” to prevent severe cuts in the Medicare rates for physicians, the Protecting Access to Medicare Act of 2014 could bring about dire consequences for many small clinical labs.
With quick test results come public health benefits and better treatment, but for some rapid diagnostic tests, accuracy remains elusive.
At the beginning of April, President Obama signed into law the Protecting Access to Medicare Act of 2014, which incorporates the first major changes in the Clinical Lab Fee Schedule’s policies and procedures since the schedule was implemented in 1984.
For every test that has been accepted for use in clinical laboratories, scores of others have been dropped.
Sometimes it’s hard to estimate the impact of shifting healthcare policies until providers actually begin putting them into practice. That seems to be the case with two significant shifts in federal policy that are now working their way toward implementation in clinical laboratories throughout the United States.
Sometimes called the “sunshine vitamin,” vitamin D is active in tissues and cells throughout the body, and is believed to help prevent or reduce a wide range of diseases. But researchers aren’t exactly sure what roles vitamin D plays, and judging how much vitamin D is enough—and for whom—remains something of a moving target.
So far as the realm of molecular diagnostics is concerned, 2013 may go into the books as a year of some significance. But further developments in the coming year could ultimately turn out to be even more important.
Some take-away from the annual conference from one of the presenters.