Companies push back against allegations of FCA violations over excess at-home blood testing

A 70-year-old former Marine is taking a group of companies to court over their at-home blood testing services, arguing that the industry players broke the law by requiring patients to conduct weekly tests. The companies then submit these bills to Medicare for reimbursement, even asking to be repaid for services that weren’t rendered, according to the complaint.

But last week, the defendants fought back in Massachusetts federal court, countering that the plaintiff could not sufficiently support his claim that the companies violated the False Claims Act.

The plaintiff, James Allen, has been on warfarin therapy since March of 2010 to treat atrial fibrillation and depressed left ventricle function, according to court documents. The standard of care for patients on long-term warfarin therapy is to undergo evaluation with a blood test once per month, the plaintiff argued.

In October of 2006, the FDA slapped a black box warning to warfarin, recommending that patients receive regular monitoring with blood tests. Companies then lobbied CMS to expand its coverage of home-testing, which it did in March of 2008.

The companies named in Allen’s suit – mdINR, CardioLink, Patient Home Monitoring (CVE:PHM), Alere (NYSE:ALR), Advanced Cardio Services, U.S. Healthcare Supply and Roche Health Solutions – all require bi-weekly or weekly testing for patients on long-term warfarin therapy, according to the plaintiff’s complaint.

Allen alleged that the defendants have been submitting false claims to CMS for tests that were neither reasonable nor medically necessary.

“This scheme bore no relation to the clinical and medical needs of patients, but rather was devised and implemented for the sole purpose of generating revenues for the defendants,” the complaint said.

The companies countered Allen’s allegations. mdINR argued that its enrollment forms explicitly require a physician’s signature testifying that the weekly or bi-weekly testing is necessary. CardioLink pointed out that Allen relied on just a phone call and a physician prescription form to make his case against the company – that’s not enough to establish sufficient support for an FCA violation, the company said.

Other companies argued that Allen did not plausibly allege that enfollment forms could coerce a doctor into prescribing medically unnecessary services. Alere noted that Allen’s claim “that doctors could not exercise medical judgment is implausible, legally defective and unsupported by his own allegations.”

Advanced Cardio Services added that “is nothing fraudulent about form prescriptions, which are used every day by doctors, hospitals and clinics.”

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