James A. Boiani, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Bloomberg BNA Health Care Daily Report, in “Labs Hopeful for Less Severe Penalties for Referral Mishaps,” by Mike Stankiewicz. (Read the full version – subscription required.)

Following is an excerpt:

Medical testing labs are hoping the Medicare agency will ease up on penalties for improperly handled proficiency test samples, health-care attorneys told Bloomberg Law.

The Centers for Medicare & Medicaid Services wants comments by March 12 on updating penalties under the Clinical Laboratory Improvement Amendments (CLIA) for when a laboratory refers out proficiency test samples to another lab and reports the other lab’s result as its own. CLIA governs nonresearch clinical lab testing in the U.S. and certifies labs that meet the program’s quality standards. Current penalties are stiff and may include losing a CLIA certificate, as well as prohibiting the lab’s owner from owning a CLIA-certified lab for two years.

But health-care lawyers say these referral mistakes are typically not done with nefarious intentions. “Many laboratories have procedures in place that automatically refer certain tests, or sometimes tests are referred out because of clerical error,” James Boiani, a life sciences attorney at Epstein Becker & Green’s Washington office, told Bloomberg Law Jan. 9. “You should still have severe penalties for bad actors, but loosen it up for staffs or labs that made an honest mistake.” …

“You don’t have to put everyone out of business for minor things, especially those who are doing it voluntarily,” Boiani said. …

Boiani said patient safety advocates are unlikely to be concerned about lab quality as a result of lower penalties.

“It’s not a concern necessarily that once they loosen it up it that proficiency testing will become the Wild West,” he said. “There should be penalties between nothing and a two-year suspension.”

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