A Georgia-based paediatric cardiologist was sentenced to 6 months’ probation after pleading guilty to violating HIPAA legislation by disclosing patient PHI to an unauthorised organisation.
Dr Eduardo Montana, 55, plead guilty at the Department of Justice in Massachusetts. The case was held in conjunction with a case against Aegerion, a pharmaceutical firm based in the state. The charges against the physician were in relation to the wrongful disclosure of patients’ protected health information (PHI) to the pharmaceutical firm.
Aegerion, a subsidiary of Novelion Therapeutics, agreed in September 2017 to pay $40.1 million following pleading guilty to misbranding and mis-marketing one of their prescription drugs, Juxtapid. The case against Aegerion was included in deferred prosecution in connection with criminal liability under HIPAA for causing false claims to be sent to federal healthcare programs for the drug.
According to the prosecutors, Aegerion received regulatory approval to market Juxtapid for treating high cholesterol in adults with rare genetic disorders. However, the pharmaceutical company proceeded to market the drug to patients who lacked the condition, and therefore did not need the drug.
A sales representative at the company sought patient information of individuals who lacked the genetic disorder, but who the company saw as suitable patients for the drug. In 2013, the drug cost $295,000 per patient.
Montana disclosed information to a senior Aegerion executive with a list of 280 of his paediatric patients who may eligible for the drug’s use. Prosecutors also stated that Montana also provided a code to access his electronic medical record system.
Aegerion confirmed that they conspired to obtain the individually identifiable health information of patients without legal permission for financial gain, in violation of 42 U.S.C. §§ 1320d-6(a) and 1320-6(b)(3) and HIPAA Rules. Aegerion agreed to pay more than $36 million in financial penalties to resolve criminal and civil liability, and agreed to pay an additional $4.1 million to resolve a related US Securities and Exchange Commission case.
Montana was charged with criminal breaches of HIPAA Rules for permitting a sales representative of Aegerion to access the confidential health information of patients without first receiving patient consent, in clear violation if HIPAA Rules. His sentence was issued as an alternative to a jail term.
This is not the first HIPAA violation case of this nature to be seen in Massachusetts in recent times. In September, Massachusetts gynecologist Rita Luthra received a sentence of one-year probation over payments received by a pharmaceutical firm (Warner Chilcott) for giving sales representatives access to the individually identifiable health information of patients for financial gain. While prosecutors were urging a fine and a jail term to be applied to act as a deterrent, Judge Mastroianni explained in his ruling, “Her loss of license and ability to practice is a substantial deterrent.”
It is worthwhile noting that Montana sought a $236,000 grant from Aegerion, which was denied. The collusion between pharmaceutical companies and wayward physicians poses as a real threat to the integrity of patient PHI. Although both physicians mentioned above avoided financial penalties and jail terms, but both could have received a fine of up to $50,000 and a prison sentence of up to a year for their crimes.