Recently, a gynecologist was sentenced to 1 year of probation for violating HIPAA laws and obstructing an investigation into a federal health care probe.
Rita Luthra, MD, who treated women in a low-income area of Springfield, Massachusetts, was convicted this past April of allowing a pharmaceutical representative from Warner Chilcott improper access to patient records. While the case is unique—providers have rarely been charged criminally under HIPAA—it is a cautionary tale about the potential implications for improper disclosure.
Dr Luthra’s conviction stemmed from a larger Department of Justice (DOJ) investigation into Warner Chilcott’s practices. The pharmaceutical company, which was purchased in 2015 by Allergan plc, was investigated on allegations of paying kickbacks to physicians to entice them to prescribe its medications to patients; false marketing for Actonel, a drug prescribed for treatment of osteoporosis; and manipulating prior authorizations for its other osteoporosis drug, Atelvia.
The DOJ reached a $125 million settlement with the company in 2015. Dr Luthra was found to be one of the physicians accused of taking part in Warner Chilcott’s practices. She was originally brought up on kickback charges, with investigators claiming she received more than $23,000 for prescribing their osteoporosis medication. They claimed she was paid approximately $750 on numerous occasions to hold educational events in her office for the pharmaceutical company.
But those charges were dropped, and a revised indictment for HIPAA charges was filed. Prosecutors claimed she gave a sales representative patient information in order to fill out forms to get an insurer to cover the drugs. She was also convicted on an obstruction charge for allegedly lying to the DOJ about why she was paid by the pharmaceutical company.
Luthra could have received up to 6 years in prison and a $300,000 fine for both charges. The judge on the case, however, said that the loss of her license and probation was enough of a sentence. He reportedly considered her work for years serving patients in lower-income communities during sentencing.
Criminal prosecutions under HIPAA are not common, but Conor Duffy, a lawyer with Robinson & Cole LLP, said it is reflective of a growing trend.
“Prosecutors appear to utilize criminal charges under HIPAA in part as a fall back or as leverage against a provider, because proving HIPAA violations can be easier than proving the existence of an illegal kickback arrangement,” Duffy said. “The Massachusetts case is notable in that the government ended up dropping its kickback allegations but nonetheless prosecuted the physician for a HIPAA violation.”
There have been a few other cases where criminal charges were applied through HIPAA, most involving providers improperly using the information or providing it to others for financial gain. In one such case, a Florida nurse used the information of more than 600 of her patients to file false tax returns with potential refunds of more than $220,000. She was sentenced to more than 3 years in prison and fined.
“Some people are doing it for personal benefit, and it’s happening more often than would be hoped for,” said Matthew Fisher, a law partner at Mirick, O’Connell, DeMallie & Lougee LLP.
When prosecutors file criminal charges, “they will come up with every single charge they can think of so one will stick,” Fisher said. Filing multiple charges allows them not only to find one that’s valid, but also allows for negotiation. And when the government begins investigating, they will likely find some issues.
“Once they start looking around they will find something even if it’s not why they came in the door,” Fisher continued “The regulations are so complex it’s difficult to be 100% compliant and as a physician, you have to live with what comes out of that.”
Stay in compliance
This case provides a good warning, particularly for smaller organizations, that HIPAA applies to practices of all sizes, according to Amy Joseph, senior counsel at Hooper Lundy & Bookman PC. It is a reminder to avoid disclosing information unless it is for treatment, claim payment, internal health care operations, the patient has authorized the disclosure, or another limited exception applies.
“Disclosure for purposes other than treatment, payment, or health care operations need to be scrutinized,” Joseph said. “Get help, talk to your counsel. Just because someone else is in health care it doesn’t mean they are going to protect the information or are asking for it for legitimate purposes. It’s better to be more cautious than not.”
Duffy said personal relationships, such as those with some pharmaceutical sales representatives, should be monitored. These salespeople are “trained to cultivate business by building such relationships.”
“Providers also need to be careful to not rationalize potentially illegal acts—like allowing a sales representative to use identifiable health information to facilitate prescriptions of a drug for a patient—on the basis that a patient could ultimately benefit from a drug or device, because the laws governing these interactions do not take that into account,” he said.
If a provider gets into a situation where a pharmaceutical representative, medical device company, or other similar health care organization is calling and asking for patient information, Fisher recommends taking a step back before providing it. Providers should look at the relationship they have with the organization. They might be using it for valid purposes such as clinical trials or reporting to the FDA.
Most providers will shrug and say they would never get into the kind of situation Dr Luthra did, but Fisher said it is not always such an obvious delineation between when information should and should not be given out.
“If they are calling out of the blue and you’re not clear why the connection is being made, question it and don’t just volunteer that information,” Fisher said. “It’s not a defense to say, ‘They told me it was OK and I never really thought about it.’ You’re always responsible for your own actions; no one is forcing you to do anything.”