Practice Fusion: A Drug Company Bought a Place in the Prescribing Decision
In the Practice Fusion opioid alerts settlement, the company agreed to pay approximately $118.6 million to resolve civil claims involving paid prescribing prompts and false electronic health record certifications. The government alleged that Practice Fusion took kickbacks from an opioid company to influence prescribing through its software. The drugmaker could reach into the tool a physician used during a patient encounter. For someone who worked on the sponsorship, the alert or the certification, the important decisions happened before the doctor ever saw the screen.
Practice Fusion developed electronic health records software. In its January 27, 2020 announcement, the Department of Justice described how pharmaceutical sponsorship entered the design of clinical decision support alerts. The civil settlement covered that prescribing influence and a separate allegation that Practice Fusion misrepresented software capabilities, causing users to claim federal incentive payments.
How Did the Paid Alerts Influence Prescribing?
The paid alerts influenced the information doctors received while deciding how to treat patients. The Justice Department alleged that Practice Fusion let pharmaceutical sponsors participate in choosing the clinical guidelines behind alerts, setting the conditions that triggered them and, in some cases, writing the words providers saw.
The opioid arrangement makes the sales purpose particularly clear. According to the criminal information, Practice Fusion solicited nearly $1 million to create an alert intended to increase prescriptions for extended-release opioids. The same information said the opioid company’s marketing department financed the payment and helped design the alert. It also said Practice Fusion promoted the arrangement on the basis that more opioid prescriptions would give the sponsor a favorable return on its investment.
That is the business connection in this pharmaceutical kickback scheme: the drug company paid the software vendor for influence over the prescribing decision.
The Justice Department also alleged that the sponsored alerts did not always reflect accepted medical standards. Between 2014 and 2019, healthcare providers using Practice Fusion’s software wrote numerous prescriptions after receiving alerts pharmaceutical companies had helped design. During the opioid crisis, a drugmaker allegedly bought influence over the medical advice its own product’s prescribers read. Patients’ treatment decisions became a sales opportunity, and the government said the opioid arrangement led to false claims submitted to taxpayer-funded health care programs.
Why the Software Vendor Mattered
Practice Fusion controlled a route into the patient encounter. The value of that route lay in the physician’s reliance on electronic health records for patient information and medical guidance, the very reliance the Justice Department identified in its announcement.
For the people building and selling the product, that arrangement connected work that might otherwise sit in different departments. Sponsorship negotiations concerned the manufacturer’s anticipated sales. An alert specification explains what appeared on screen. The commercial discussions explain why the company wanted it there.
The same purchase of a trusted clinical channel appears in the pharmacy counseling allegations against Novartis. In its November 20, 2015 settlement announcement, the government described how Novartis used control over patient referrals to pressure specialty pharmacies to assign nurses to call Exjade patients and encourage more refills. The government said the calls emphasized benefits while understating serious risks.
The useful comparison is who controlled the clinical message. In the Novartis case, it reached the patient through pharmacy nurses. In Practice Fusion’s case, it reached the prescriber through software. In both, the commercial arrangement helps explain the recommendation. That is why a person who knows the sponsorship or referral terms may see something that the person receiving the advice cannot.
What Did the Civil Settlement Cover?
The Practice Fusion civil settlement covered the opioid arrangement, allegations involving thirteen other sponsored-alert arrangements and separate software-certification allegations. The other arrangements allegedly used alerts intended to increase sales of the pharmaceutical sponsors’ products. The civil settlement therefore covered more than opioid prescribing.
The announced civil allocation included approximately $113.4 million for the federal government and up to $5.2 million for states choosing to participate in separate agreements.
The distinction matters to an insider because the relevant business records differ. A sponsorship agreement and its sales projections concern the prescribing channel. A software test, certification submission or export failure concerns what the product could do and what the certifier was told. The settlement brought those subjects together, but the work inside the company can reveal either one.
EHR Certification and the Patient Data Users Could Not Export
The EHR certification allegations concerned capabilities Practice Fusion claimed its software had. The government alleged that the company concealed failures from its certifying body and obtained certification for versions that did not meet all the requirements. Providers then used those products while claiming government incentive payments.
The certification and payment programs served connected purposes. The Office of the National Coordinator for Health Information Technology set certification criteria intended to improve software functionality, security and access to patient information across care settings. The Centers for Medicare & Medicaid Services oversaw the incentive programs. A product’s certification could therefore affect a provider’s eligibility for public money.
The export feature shows the alleged mismatch in concrete terms. The 2014 Edition criteria required software to let users electronically create standardized export summaries for all patients. The government alleged that several Practice Fusion versions could not do that when certified, despite the company’s representation that they met the requirement.
The government further alleged that Practice Fusion later disabled access to the feature altogether. Users had to contact the company separately to request an export of patient data. A capability presented as something the user could do became something the user had to ask the vendor to do.
The settlement also covered allegations that the software failed to incorporate required standardized vocabularies. The government’s payment theory was that Practice Fusion knowingly caused eligible providers using certain versions to falsely attest that they met the requirements for incentive payments.
This part of the case reaches people whose work may have had little to do with pharmaceutical sponsorship. Someone testing exports, handling customer requests or preparing certification material may know the difference between the promised capability and the working product. That difference was central to the government’s separate incentive-payment allegations.
What Evidence Is Needed to Prove Fraud?
For paid prescribing prompts, the evidence connects the sponsor’s payment and sales objective to the alert’s design, the prescribing it sought to influence and the resulting government claims. For the certification allegations, it connects what the vendor represented to what the software could actually do and the incentive payments that followed. Those are the connections our whistleblower experts examine with someone who knows the product.
On the alert side, a commercial employee may recognize a sponsorship agreement or presentation forecasting increased drug sales. A product manager or developer may recognize the sponsor’s requested guideline, the trigger conditions or edits to the alert language. A colleague who worked across those functions may know how a marketing request became a software requirement. We look at those records together because the public-facing recommendation shows only part of the transaction.
On the certification side, we examine the relationship between testing, representations to the certifier and the experience of customers using the same software version. In this case, the alleged need to ask the vendor for an export gives that comparison a specific focus. A customer-support account and a certification submission may describe the same feature very differently.
An insider’s knowledge can connect decisions made in separate teams. Your part may be the commercial promise, the product change or a customer’s export problem. We work with you to understand how it fits the payment at issue and build the case around that connection.
A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.
You Know How the Recommendation Got There
If you saw a drug company’s sales objective become an alert, or a certification claim outrun the software, speak to one of our whistleblower experts about the decisions behind it. We bring in pharmaceutical fraud whistleblower lawyers who understand software-driven prescribing and federal payment claims, and work beside you throughout the process to build your strongest whistleblower case.
