A federal judge won't bar mention of allegations in a False Claims Act kickback case against a medical center that did not appear in a whistleblower's complaint.

U.S. District Chief Judge Joy Flowers Conti of the Western District of Pennsylvania denied defendants Hamot Medical Center and Medicor Associates' motion to preclude evidence that certain medical department directorships, allegedly given as kickbacks to doctors for inducing patient referrals, were not memorialized in writing.

Relator Tullio Emanuele's claims were filed under the Stark Law and the Anti-Kickback Act, which prohibit health care entities from submitting claims to Medicare based on referrals from physicians who have a “financial relationship” with the health care entity, according to Conti's Oct. 26 opinion.

The defendants argued that Emanuele should be barred from presenting any evidence to the jury relating to the writing requirement in certain exceptions found in the Stark Law and Anti-Kickback Act because he never alleged the absence of a written agreement in his amended complaint.

“Relator's FCA claim requires him to demonstrate that the defendants falsely and knowingly certified their compliance with the Stark Law and Anti-Kickback Act while submitting claims for payment to the government that were tainted by patient referrals between health care entities engaged in a financial relationship,” Conti said. “Relator's amended complaint contains reasonably detailed allegations that Hamot and Medicor knew about the prohibitions against illegal referrals and kickbacks under the Stark Law and Anti-Kickback Act, but entered into medical directorships for the purpose of inducing referrals and submitting claims for payment to the government based on those referrals.”

She added, “The theory that relator purportedly failed to plead in his amended complaint—the absence of a written agreement—relates entirely to an affirmative defense on which defendants bear the burden of proof.”

Conti also granted Emanuele's burden of proof motion, in which he argued that his claims must be proven by a preponderance of the evidence, not by clear and convincing evidence or beyond a reasonable doubt, as the defendants claimed.

Emanuele and the U.S. government were represented by Collin J. Callahan of the U.S. Attorney's Office for the Western District of Pennsylvania, who did not respond to a request for comment.

Medicor's attorney, Neal R. Devlin of Knox McLaughlin Gornall & Sennett in Erie, also did not respond to a request for comment.

Hamot was represented by Pittsburgh lawyer Stephen Stallings, who declined to comment on the decision.

A federal judge won't bar mention of allegations in a False Claims Act kickback case against a medical center that did not appear in a whistleblower's complaint.

U.S. District Chief Judge Joy Flowers Conti of the Western District of Pennsylvania denied defendants Hamot Medical Center and Medicor Associates' motion to preclude evidence that certain medical department directorships, allegedly given as kickbacks to doctors for inducing patient referrals, were not memorialized in writing.

Relator Tullio Emanuele's claims were filed under the Stark Law and the Anti-Kickback Act, which prohibit health care entities from submitting claims to Medicare based on referrals from physicians who have a “financial relationship” with the health care entity, according to Conti's Oct. 26 opinion.

The defendants argued that Emanuele should be barred from presenting any evidence to the jury relating to the writing requirement in certain exceptions found in the Stark Law and Anti-Kickback Act because he never alleged the absence of a written agreement in his amended complaint.

“Relator's FCA claim requires him to demonstrate that the defendants falsely and knowingly certified their compliance with the Stark Law and Anti-Kickback Act while submitting claims for payment to the government that were tainted by patient referrals between health care entities engaged in a financial relationship,” Conti said. “Relator's amended complaint contains reasonably detailed allegations that Hamot and Medicor knew about the prohibitions against illegal referrals and kickbacks under the Stark Law and Anti-Kickback Act, but entered into medical directorships for the purpose of inducing referrals and submitting claims for payment to the government based on those referrals.”

She added, “The theory that relator purportedly failed to plead in his amended complaint—the absence of a written agreement—relates entirely to an affirmative defense on which defendants bear the burden of proof.”

Conti also granted Emanuele's burden of proof motion, in which he argued that his claims must be proven by a preponderance of the evidence, not by clear and convincing evidence or beyond a reasonable doubt, as the defendants claimed.

Emanuele and the U.S. government were represented by Collin J. Callahan of the U.S. Attorney's Office for the Western District of Pennsylvania, who did not respond to a request for comment.

Medicor's attorney, Neal R. Devlin of Knox McLaughlin Gornall & Sennett in Erie, also did not respond to a request for comment.

Hamot was represented by Pittsburgh lawyer Stephen Stallings, who declined to comment on the decision.