Alere INRatio: Unreliable Readings and the Medicare Bill
Alere agreed to pay $38.75 million in the Alere INRatio settlement over allegations that it knowingly sold defective blood coagulation monitors and billed, or caused others to bill, Medicare for their use. The government’s account put internal research, outside complaints and warnings at the center of the case. For someone inside a device company, that is the part worth recognizing: what the business knew about a result patients and clinicians were relying on.
The Department of Justice announced the settlement on July 8, 2021. It covered allegations that Alere knowingly sold defective INRatio monitors from 2008 to 2016.
What the INRatio Monitor Was Used For
INRatio blood coagulation monitors were used by Medicare beneficiaries taking anticoagulant drugs such as warfarin. Monitoring helped determine a clinically appropriate and safe dose. Too much anticoagulant can cause major bleeding. Too little can cause blood clots and strokes.
The government’s allegation was that some INRatio patients received inaccurate and unreliable readings from a system Alere already knew had a material defect.
The Algorithm Problem Alere Allegedly Knew About
The United States alleged that Alere knew, since at least 2008, that the software algorithm in each version of its INRatio monitors contained a material defect. According to the government, Alere’s own internal research, external complaints and warnings had revealed a system limitation producing inaccurate and unreliable results for some patients.
In the government’s account, Alere concealed the defect despite knowing that INRatio systems had been linked to more than a dozen deaths and hundreds of injuries, including bleeding in the brain. The company allegedly continued billing Medicare for use of the defective devices.
Patients relied on those readings to guide their medication. Taxpayers were billed for use of devices the company allegedly knew could not be trusted.
From a Device Result to a Medicare Claim
The INRatio case reached the manufacturer through allegations that it both billed Medicare and caused others to bill the program for defective testing devices. The government’s payment theory followed the product beyond Alere’s sale and into its use in patient care.
The manufacturer holds the product’s testing information. The clinical user sees the result that guides care. In INRatio, the government’s allegation connected what Alere knew about unreliable results to Medicare bills for using its monitors.
Food and Drug Administration marketing authorization and Medicare payment are separate decisions. That distinction matters here because the alleged defect reached beyond the product’s performance: the government said Alere kept billing for its use while concealing the problem.
The Recall That Removed INRatio From the Market
The devices came off the market in 2016 following a nationwide Class I product recall undertaken at the Food and Drug Administration’s request. The government alleged that Alere had failed to take appropriate corrective action until then.
What Evidence Is Needed to Prove Fraud?
Our whistleblower experts work with you to assess what your information can establish about a device failure and the Medicare billing behind it. In a case like INRatio, that means understanding the testing and the company’s response alongside the claims for using the product.
A manufacturer’s complaint database can reveal a pattern that an individual clinician, customer or billing employee sees only in part. The manufacturer sits at the center of that information and has a financial interest in the product it is evaluating.
That makes the handling of a complaint as important to this inquiry as its arrival. Internal testing, evaluation of the cause, decisions about corrective action and communications about the result can connect a reported problem to a company decision. A quality employee may recognize that sequence in the work they already do.
A former senior quality-control analyst brought the separate Alere Triage case, which led to Alere’s March 2018 settlement over unreliable diagnostic devices.
How Much Is a Whistleblower Claim Worth?
A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. The value an insider brings is the information that connects the conduct to the claim.
Someone who understands the testing, the warnings or the billing may be able to explain a connection that a public announcement never could.
You Know What the Testing Showed
If you saw unreliable results, internal warnings or decisions to keep a device in use while Medicare was billed, speak to one of our whistleblower experts about what happened inside the business. We build your strongest medical device whistleblower case with you, bring in medical device fraud whistleblower lawyers who understand product failures and Medicare claims, and stay beside you through the pursuit of a recovery.
