Clinical labs await verdict on burdensome federal requirement

The physician-signature rule is but one of several issues facing clinical laboratories as the government balances the promise of new technologies with the need for tighter regulations. 

In particular, genetic testing is a hot topic in Washington as lawmakers and federal regulators determine the essential benefits that health insurers will have to cover in state health insurance exchanges starting in 2014. 

The law also calls for comparative effectiveness research that weighs the success of drugs and procedures, which has sparked concerns that Medicare could eventually refuse to cover tests that may be useful for subsegments of the population.

Simultaneously, the Food and Drug Administration is weighing whether it should start regulating direct-to-consumer genetic tests. 

Lawmakers discussed some of those issues during a recent breakfast sponsored by the ACLA and hosted by The Hill.

Rep. Charles Gonzalez (D-Texas) said during the March 17 event that he would likely support having insurers in the exchanges be required to cover genetic tests.

"The thrust of our bill was prevention and wellness," he said. "And this ties right into that." 

He also urged his colleagues to support prevention and wellness investments such as genetic testing, even though the Congressional Budget Office typically weighs their cost but not their uncertain benefits. He said genetic tests and personalized medicine could help reduce the nation's $136 billion-a-year cost of adverse drug reactions.

"Members of Congress can show common sense and still make those decisions," Gonzalez said.

During the same breakfast, Rep. Michael Burgess (R-Texas) declared that he'd ordered such a test after reading about it in 2007 and since then has been taking a baby aspirin every night because of his high genetic predisposition to heart disease.