A Florida cataract surgeon's practice of delegating significant portions of his patients' surgeries to physician assistants is "unorthodox and controversial," but it doesn't constitute Medicare fraud, a federal court has ruled.

James P. Gills, MD, the director and part-owner of one of the nation's largest eye surgery centers, a 4-decade cataract specialist and the man who claims to have implanted more intraocular lenses than any other physician in the world, routinely relies on licensed, experienced PAs to perform limbal incisions, viscoelastic injections, capsulotomies and hydrodissections, often while he is operating in another OR. Upon his arrival in the room, he phacoemulsifies patients' lenses and implants their IOLs.

Because he's billed Medicare under his own provider number for these collaborative procedures, former patient Samuel L. Armfield III, MD, filed a whistleblower lawsuit alleging violations of the federal False Claims Act. In a summary judgment earlier this year, though, a judge found no merit in the lawsuit's primary claim and ruled in favor of Dr. Gills.

"Dr. Gills' model is highly unusual and not widely accepted in ophthalmology communities in the United States," wrote U.S. District Judge James D. Whittemore in the March 31 ruling. However, the lawsuit's "evidence does not provide a basis for finding that Defendants' [billing] certifications were knowingly false or fraudulent."

Dr. Gills examined Dr. Armfield, a diagnostic radiologist, at St. Luke's Cataract and Laser Institute in Tarpon Springs, Fla., in March 2005. He diagnosed a right-eye cataract and scheduled a removal surgery at the adjoining St. Luke's Surgical Center. The surgery was routine and successful, say court documents. Dr. Armfield returned a week after surgery for an IOL rotation to correct blurry vision, but experienced no complications.

Dr. Armfield and his wife, Patricia Armfield, RN - who, court records note, observed the surgery - filed their lawsuit in December 2007, citing Dr. Gills' billing for services performed in large part by James Marone, an unsupervised PA, as well as other billing inconsistencies.

In January 2010, the Armfields also lodged an ethics complaint with the American Academy of Ophthalmology, accusing Dr. Gills of failing to obtain patients' consents for surgeries conducted by PAs and to maintain records detailing the surgical tasks they performed. A lack of direct supervision of PAs, they argued, increases the risk of morbidity and mortality.

In response, Dr. Gills pointed out that Dr. Armfield signed a consent form authorizing Dr. Gills "and/or associates or assistants of his choice to perform" the surgery. He also filed a defamation lawsuit (which he later voluntarily dropped) against the Armfields and their attorney, Edward A. Olds, for the alleged damage that the complaint did to his professional reputation. Dr. Gills's attorney, Mark D. Colley, declined to comment on the results of the complaint. Attorneys for the Armfields did not return calls seeking comment.

In his March 2011 ruling, Judge Whittemore explained that federal law lets physicians bill Medicare for supervised PA services under certain circumstances, and that state medical rules define "direct supervision" as "immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed."

Experts may disagree on whether delegating significant surgical tasks to assistants "falls within the bounds of reasonable medical judgment regarding the probability of morbidity and mortality to the patient," he wrote. But "the physician's certification that he personally furnished the surgical procedure billed to Medicare [was] accurate, and to the extent that it was inaccurate, was based on an objectively reasonable interpretation" of CMS rules.

The remaining counts in the Armfields's lawsuit, which allege Medicare billing inconsistencies in a post-op examination, the IOL rotation and self-referrals from a physician-tenant at St. Luke's, face Dr. Gills' motions to dismiss in the first quarter of 2012. "We've made no secret to the court that we think this whole case is frivolous," says Mr. Colley. If they're not dismissed, the lawsuit could reach a trial in July.

David Bernard