Enforcement & Kickback Risk · Investigative Methods
DOJ Is Cross-Referencing Your Open Payments Data to Find Kickbacks
The transparency data your company is required to file is now functioning as an investigative starting point, not a passive disclosure filed once a year and forgotten.
A pharmaceutical manufacturer's August 2026 kickback settlement, resolved for more than $46 million, was reportedly built using a specific investigative method: cross-referencing the company's own Open Payments submissions against prescribing pattern data to identify statistical outliers, according to analysis from Goodwin Procter following the Department of Justice's (DOJ) announcement. If that account is accurate, the transparency data your company is required to file is now functioning as an investigative starting point, not a passive disclosure filed once a year and forgotten.
What "whole-of-government" enforcement means here
The case involved eight federal agencies and offices, not just DOJ and the Centers for Medicare & Medicaid Services (CMS): the FBI, the HHS Office of Inspector General (HHS-OIG), the Defense Criminal Investigative Service (DCIS), the VA Office of Inspector General, the Office of Personnel Management's Office of Inspector General, and the U.S. Postal Service's Office of Inspector General, alongside DOJ's Civil Division and the U.S. Attorney's Office. That range of participants is a reminder that False Claims Act exposure in pharma isn't confined to Medicare and Medicaid. Any federal health benefit program that paid a claim influenced by an alleged kickback is a potential source of liability, and a potential investigative partner.
Prescribing-pattern cross-referencing appears to be standard DOJ practice now, not a hypothetical audit exercise. That raises the stakes on getting Open Payments reporting right, since the data itself can become the thread that gets pulled.
The broader trend: DOJ closed FY2025 with a record year for False Claims Act enforcement.
$6.8B
FY2025 False Claims Act settlements and judgments, the highest single-year total in the statute's history. More than $5.7B tied to health care.
1,297
Qui tam whistleblower filings in FY2025, a record, up from the prior record of 980 the year before.
The fact pattern this method is built to catch
The conduct in this case fell into three categories, and all three are visible in the kind of data DOJ is reportedly cross-referencing:
- Sham consulting and advisory arrangements without a legitimate business need, held in settings not conducive to genuine education, or compensating HCPs regardless of whether the work happened. This is precisely the pattern flagged in HHS-OIG's Special Fraud Alert on Speaker Programs, which calls out high-prescribing HCP selection, entertainment-adjacent venues, and compensation untethered from genuine speaking or consulting value.
- Specialty pharmacy "enhanced services" fees, where per-patient or per-month payments were made for data or support services that, per the government's allegations, weren't meaningfully used or reviewed by anyone at the company. Value flowing through a distribution intermediary rather than directly to a prescriber can obscure the link between payment and prescribing behavior, even when the underlying economics still function as an inducement.
- Deliberate concealment, including falsified expense reports and underreporting to CMS's Open Payments program. An aggressive but disclosed marketing practice can sometimes be argued as a defensible, if incorrect, legal position. That argument is much harder to make once internal records have been altered to hide the same payments from the government's own transparency database.
Why specialty pharmacy and third-party arrangements deserve extra scrutiny
If your compliance monitoring focuses primarily on direct HCP payments, this case is a reason to widen the lens. A fee paid to a specialty pharmacy, a patient support vendor, or another third-party channel doesn't automatically fall outside kickback exposure just because the money doesn't touch a prescriber's hands directly. What matters is whether the arrangement functions as an inducement and whether the services paid for were actually delivered and used.
That's a harder thing to monitor through a spreadsheet, and it's exactly the kind of pattern that a cross-referenced dataset, matching payments against prescribing behavior, is designed to surface.
What this means for your monitoring approach
- Treat your own Open Payments data as an audit target, not just a filing obligation. If DOJ can cross-reference it against prescribing patterns, your compliance team can and should be running the same analysis internally first.
- Extend monitoring to third-party and specialty pharmacy channels, not just direct-to-HCP payments.
- Reconcile what a vendor was paid for against what it can demonstrate it delivered. "Enhanced services" fees with no documented deliverable are a specific, named risk pattern now.
Frequently asked questions
What does “whole-of-government” enforcement mean?
It refers to the Department of Justice (DOJ) coordinating with multiple federal agencies and offices, beyond just the Centers for Medicare & Medicaid Services (CMS) and the HHS Office of Inspector General (HHS-OIG), when a kickback scheme touches claims paid by more than one federal health benefit program, such as Medicare, Medicaid, TRICARE, or the VA health system.
Can Open Payments data actually be used to detect kickbacks?
According to legal analysis of this case, yes. Cross-referencing a company's Open Payments submissions against prescribing pattern data can reveal statistical outliers, such as unusually high-prescribing HCPs receiving disproportionate consulting or speaker fees, that can become the starting point for an investigation.
Is paying a specialty pharmacy instead of a doctor directly a way to avoid kickback risk?
No. If an arrangement functions as an inducement to prescribe or purchase a product reimbursed by a federal health care program, routing the payment through a specialty pharmacy or other third party doesn't remove Anti-Kickback Statute exposure. It can make the arrangement harder to monitor, not less risky.
What is a Special Fraud Alert?
A Special Fraud Alert is guidance issued by the HHS Office of Inspector General (HHS-OIG) identifying specific arrangements or practices it views as presenting a high risk of fraud and abuse under the Anti-Kickback Statute, such as its alert on speaker program arrangements.
