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.
0 Comments
On Tuesday, January 21, 2025, the Garden State officially opened the registration process for its State Price Transparency Reporting (SPTR) program. This means that drug manufacturers who meet the reporting criteria must now register with the Drug Affordability Unity at the NJ Division of Consumer Affairs and prepare to comply with the state's drug price transparency requirements.
All reporting entities - including drug manufacturers - have a short window to register; registration is required by January 31, 2025. To register, manufacturers must use the Excel spreadsheet template provided. For additional guidance, you may refer to the Data Collection Manual. While not explicitly stated in the Manual, it appears that the "entity type" for drug manufacturers should be: "Manufacturer." Moreover, it appears that completed registration forms should be emailed to: [email protected]. As a reminder, in NJ, reporting of applicable price increases and new drugs already went into effect on August 1, 2024. To visit the NJ registration page for more info, please see here. 2024 was a record-setting year for new State Drug Price Transparency Reporting (SPTR) requirements. From California to New Jersey, North Dakota to Texas, Maine to New Mexico, Washington to Florida, we've seen new SPTR laws enacted in every area of the country and across the political spectrum.
But brace yourselves because 2025 is picking up right where we left off. In fact, while we are just a few days into the new year, we already have one of our first bills in New York that is proposing new SPTR requirements (in addition to the NY law that was already enacted last year)! Already managing perpetual SPTR requirements in 15+ states with 30+ price increase calculations (not to mention new drug notifications and similar reporting ) is enough to make your head spin. To alleviate this burden and help avoid potential regulatory scrutiny by exceeding price increase thresholds (not to mention severe enforcement penalties which have already been levied against the industry), our clients have trusted our cost-effective reporting services and first-of-its-kind software platform, Rx Price Transparency Tracker, which provides instant analysis on drug pricing considerations and their regulatory impact. We've started this blog to help keep the industry informed of SPTR (and Spend Transparency) reporting requirements. Keep checking back for more updates. In the meantime, we hope you had no issues submitting the Louisiana SPTR report and have submitted or are about to submit the other January SPTR reports, such as North Dakota, Texas, West Virginia, Maine, Pennsylvania, and California. Good luck! |
Categories |