James Boiani Quoted in “New Stakeholder Group Wants FDA to Reform CLIA Waiver Process”

Bloomberg BNA's Health Care Daily Report

James Boiani, Senior Counsel in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "New Stakeholder Group Wants FDA to Reform CLIA Waiver Process."

Following is an excerpt:

A newly formed stakeholder group wants the Food and Drug Administration to ease restrictions on where diagnostic tests can be performed.

James Boiani, head of the Coalition for CLIA Waiver Reform and an attorney with Epstein Becker & Green PC in Washington, told Bloomberg BNA May 28 the group wants the FDA to ease its regulations and ensure patients have easy access to important diagnostic tests. …

According to the coalition, all laboratory tests must be reviewed by the FDA and assigned a complexity level (low/waived, moderate or high). The complexity level dictates where the test can be performed. Moderate- and high-complexity tests may be performed only in sophisticated laboratories that satisfy the strict requirements of CLIA (including personnel training, quality standards, proficiency testing and recordkeeping requirements, among others).

Boiani said tests performed in CLIA-waived lab are simple and are often performed at the point of care, such as a physician's office. …

Boiani said the coalition wants the FDA to change the way it interprets the CLIA law. …

"The only issue is whether the tests perform the same way" in a CLIA-waived lab, Boiani said. If they do, "there's no reason to restrict access to only complex labs. The results are being used the same way." …

The agency issued two other guidance documents on CLIA waivers since, most recently in 2008, but each has deviated from the 2001 guidance, Boiani said. He said the coalition is pushing for the FDA to issue a new guidance document that is more in line with the 2001 version than the 2008 version.

"FDA got it right the first time," Boiani said. "The current regulations don't seem like they're adding much." He added the FDA isn't focusing on the right question, which is: "Will the tests perform equally well?"