The district court granted a motion to dismiss a qui tam complaint alleging healthcare fraud, finding that the relator had not shown the alleged fraud was material. The relator alleged that the defendants improperly delegated the process of obtaining informed consent from surgery patients to practitioners other than the surgeons expected to perform the procedures. However, the court found the complaint did not provide a defined standard process for obtaining informed consent and therefore could not say whether the alleged deviation was fraudulent. The court also found no definitive certification attesting whether the defendants had followed a specific process. Even accepting the allegations as true, the court found the defendants may have, at worst, skated around a requirement, not committed fraud. The court concluded that the allegations described a regulatory violation that might have resulted in a compliance order, not in a rejection of the defendants’ claims for payment.
University of Pittsburgh Medical Center and its co-defendants moved to dismiss a qui tam complaint alleging healthcare fraud, arguing that the relator failed to show that the alleged fraud was material to the government’s payment decision.
Zaldonis alleged that UPMC surgeons improperly delegated the responsibility to obtain patients’ consent for surgical procedures to residents, fellows, nurse practitioners, and physician assistants, in violation of federal and state law. The surgeons often signed a consent form falsely certifying that they had explained to the patient all of the information in the consent form, when, in fact, they had not. The relator asserted that this false certification rendered any relevant claims for payment fraudulent. Zaldonis alleged that the claims forms certified that the hospital was in compliance with all applicable Medicare and Medicaid laws, regulations, and instructions for payment.
The defendants moved to dismiss, arguing that the complaint failed to identify an applicable regulation prohibiting a patient’s principal surgeon from delegating the informed consent process to other practitioners. Further, even if delegation of the informed consent process is prohibited, the defendants argued that the complaint failed to plead either an express or implied false certification claim under the FCA. In short, because the certifications do not make any representations about the consent process, do not specifically affirm compliance with any consent-related regulation, and fail to adequately show that the consent process is material, the defendants argued that the relator had failed to state a claim. Finally, the defendants argued the relator failed to satisfy either the plausibility or particularity standards.
The court agreed that Zaldonis failed to adequately plead that the government would have refused to pay for certain surgeries had it known that UPMC physicians were delegating the task of obtaining patient informed consent to other practitioners. While the court declined to concede the defendants’ assertion that informed consent violations can never be material for FCA purposes, it held that the relator failed to show that they were material in this instance.
The complaint cited regulations relating to patient rights under government funded healthcare programs, including the right of informed consent. However, while various regulations require that a patient’s file include a properly executed consent form, the court found no definition of “properly executed.”
Zaldonis argued that the formal requirements for a properly executed patient informed consent form are supplied by state law and hospital policy. Further, she noted that under Pennsylvania medical malpractice law, informed consent is a non-delegable duty that rests with the lead physician. Connecting these requirements, the relator argued that a physician who delegates obtaining informed consent to another practitioner violates applicable federal regulations, thereby rendering false any request for payment that certifies compliance with applicable rules and regulations.
However, even assuming that this line of reasoning was correct, the court found the relator’s arguments would establish falsity, but not materiality. The court found no citation in the Medicare conditions of participation or CMS state operations manuals stating whether or not the delegation of informed consent would affect the government’s payment decision.
The relator asserted that she adequately alleged that: (1) informed consent is a “condition of payment” under Medicare regulations; (2) it is a “core patient’s right” and therefore is “central to the bargain;” and (3) certain administrative law cases show the government has excluded providers from participation in Medicare for failure to properly obtain informed consent.
However, the court found these arguments lacking. First, the court found that informed consent appears in regulations touching on Medicare conditions of participation, not payment, which the court explained is an important distinction. A violation of a condition for participation might be, but is not necessarily, material for FCA purposes. Other courts have recognized that the government has an oversight regime designed to maintain provider standards, like informed consent processes. Under that system, the government does not immediately suspend billing privileges but gives the provider an opportunity to correct their procedures before drastic measures are taken. Further, the relator cited cases showing that the government might penalize repeated failures to obtain informed consent, but none where the government declined to pay claims when informed consent was delegated.
Finally, even accepting the relator’s arguments, the court noted that Zaldonis did not allege that patients were not given information, only that the information supporting informed consent was provided by the wrong practitioner. The court found the case cited by the relator inapposite. In that case, the relator alleged that patients were denied an opportunity for informed consent, because the physicians scheduled to perform their surgeries were not the physicians who actually did so. The relator did not allege that the “wrong” practitioner provided information but that patients were not provided with important information about their surgery, i.e.: that their physicians would not perform their surgeries.
The court found no such allegation here and, in fact, noted that some of the representative examples did not match up to the alleged misconduct or were not supported by details. For example, the relator alleged one instance where no consent was obtained and another in which consent was allegedly obtained from the husband of the patient, rather than the patient herself. Neither example alleged that informed consent had been improperly delegated. Further, neither example asserted fraud, rather than a potential medical malpractice issue.
While the court acknowledged that informed consent is an important part of medical care, it explained that the FCA is not an all-purpose anti-fraud statute. The court was not convinced that the government would have refused to pay claims had it known of the deficiency. Accordingly, the court dismissed the claims.
