Search Results: Medical Devices

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Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough Devices Program.”  CMS’s proposal – the Medicare Coverage of Innovative Technology, or MCIT, Pathway – was groundbreaking in…

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Alere Pays $198.75 Million to Settle False Claims for Allegedly Billing Medicare for Defective POC Devices, Not Charging Copays, and Sending Supplies to Deceased Patients

Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False Claims Act violations for a total of $198.75 million. The first series of settlements was announced…

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Patient Stakeholder Group Zeroes in on Medical Device Industry

In recent months, the Kaiser Health Network (part of the Kaiser Family Foundation) has issued three reports scrutinizing the orthopedic industry and its practices.  Each report articulates the stakeholder group’s concerns over relationships among orthopedic and spinal surgeons, orthopedic implant manufacturers, and their sales representatives.  Medical device manufacturers, especially those…

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Is Prescription Support Software Classified as a Regulated Medical Device in Europe?

…the essential criterion for being classified as a medical device is the software’s medical objective… Background Relying on an unregulated app or piece of standalone software to provide a diagnosis or recommend treatment could have potentially life-threatening consequences. In June 2020, the UK’s medical devices regulator, the Medicines and Healthcare…

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