Devices

Arriva Medical (Alere) Paying $160 Million on False Claims Charges

Arriva Medical, at one time the nation’s largest mail-order diabetic testing supplier, and its Alere parent will pay $160 million to resolve allegations they violated the False Claims Act. A Justice Department news release says Arriva ceased business operations 12/2017. It was acquired by Alere in 2011.

The settlement resolves allegations that Arriva and Alere made or caused claims to Medicare that were false because kickbacks were paid to Medicare beneficiaries, patients were ineligible to receive glucometers, or patients were deceased.

The federal government alleges that from 4/2010 until the end of 2016, Arriva, with Alere’s approval, paid kickbacks to Medicare beneficiaries by providing them “free” or “no-cost” glucometers by routinely waiving or not collecting their copayments for meters and diabetic testing supplies.

The release says the settlement also resolves allegations that Arriva and Alere caused the submission of false claims to Medicare for glucometers because the companies allegedly systematically provided to all of its new patients, and billed Medicare for, a meter without regard to the patients’ eligibility for one. And it resolves claims that Arriva submitted false claims to Medicare on behalf of deceased beneficiaries. Medicare revoked Arriva’s Medicare supplier number 11/2016 for submitting such claims, the Justice Department says.

A former Arriva call center employee brought a whistleblower claim against the company, which later was taken over by the federal government. The whistleblower, Gregory Goodman, will receive nearly $29 million from the settlement proceeds.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome