As reported by PolicyMed, Biohaven, a Pfizer subsidiary, recently resolved a settlement with the Department of Justice (DOJ) for nearly $60 million. While the settlement resolved allegations of false claims related to improper physician remuneration for speaker programs, notably the case also highlighted violations of the Open Payments law for the failure to report speaker payments to CMS.
In the legal complaint, the Department of Justice stated that "Biohaven now attempts to hide the number and payments it made to speakers to cover up its quid pro quo activities. Biohaven is required by federal law to report all payments made to prescribers for the entire year in the first reporting period the following year. Notwithstanding the actual data contained in Biohaven’s internal documents, the Company reported to CMS only approximately ten percent of the payments made to each of the speakers in order to prolong its scheme." The significance of this claim is two-fold. First, the DOJ used Biohaven's apparent failure to report accurately under the Open Payments law as evidence that Biohaven attempted to hide illegal arrangements with HCPs, bolstering the DOJ's false claims allegations. Second, the failure to report likely allowed the DOJ to negotiate a larger settlement against Biohaven in light of civil monetary penalties that can be levied under the Open Payments law for failure to report accurately. This case is yet another example of the government using Open Payments data (or the lack thereof) to strengthen the case for enforcement against life sciences manufacturers - not to mention imposing millions of dollars more in settlement amounts. With the CY2024 report deadlines fast approaching, it also underscores the need for accurate and complete reporting under state and federal spend transparency laws, as well as the importance of viewing the data through a compliance lens prior to reporting.
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