James Boiani Quoted in “Coming Together on CLIA Waivers? Industry Hopes to Recruit Patients, Providers to Push Reform”

The Gray Sheet

James Boiani, a Senior Counsel in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Coming Together on CLIA Waivers? Industry Hopes to Recruit Patients, Providers to Push Reform."

Following is an excerpt:

About half a dozen diagnostic test firms that make point-of-care assays have decided the time is ripe to make a change. They met for the first time as the Coalition for CLIA Waiver Reform last month to launch the effort. The coalition, which is not yet publicly identifying its members, is spearheaded by James Boiani, a Washington, D.C.-based attorney at Epstein Becker & Green, who says he has become increasingly frustrated with the process as he works with clients to obtain CLIA waivers. He believes FDA is misinterpreting the law in its current guidance at the expense of expanding point-of-care testing that can help facilitate faster diagnosis and treatment for more conditions.

"This has been sort of a passion project of mine," Boiani said in an interview. "I plan to dedicate a lot of free time to advocate for this position." …

Boiani now hopes that new tactics will have more of an impact on the policy than the industry comments to the draft guidance did. The initial efforts of the new coalition will not be drafting statements to FDA, he says, but engaging patient groups, medical organizations and CLIA-waived labs. …

Also, Boiani says, the coalition wants to change any remaining public mindset that CLIA-waived labs are inherently unsafe or incompetent.

"We need to draw in a broader base, and go to the public, and go to the doctors, go to the patients... and have a discussion, ‘do you want these tests?'" he said. "If we can convince them, than we can go to the FDA and say we have got this group of people, we are not just diagnostic companies... and we are telling you this is really time to revisit this issue. I think that is going to be a lot more persuasive to FDA." …

Boiani says he is not expecting overnight success. It will take years to build a broad coalition and effectively deliver the message to FDA, he acknowledges. The group also plans to try to enlist help from members Congress. …

Boiani says he is still digging into available data to illustrate the different timelines and expenses associated with the process prior to and after 2008. Industry estimates suggest it may be from six to 20 times more expensive under the current system, he says.

With the lab-to-lab performance comparison that previously underpinned the system, "it was pretty easy to see if you had hit your target or not," Boiani said. "Now... it is much more complicated."

He explains that about 200 tests gain CLIA waiver per year, but that almost all of those are just new variants of old test categories that are automatically waived in regulations, or are tests approved as over-the-counter products, which are also automatically waived, and don't need to independently gain a CLIA waiver determination.

"We are not concerned about the 195 tests that are getting the automatic waiver, because they are not really innovative tests," Boiani says. "We are concerned about the five that are having trouble getting through the process, because there is something novel about them, either the technology or the specific biomarker they are measuring."