Becker's Spine Review

17 SPINE SURGEONS FDA reclassification of posterior cervical screw systems to cost companies $13K: 5 things to know By Laura Dyrda T he FDA issued a final rule cementing posterior cervical screw systems as a class 2 device and will maintain the premarket notification requirement. Five things to know: 1. Effective May 1, the FDA defined a posteri- or cervical screw system as a device "used to provide immobilization and stabilization in the cervical spine as an adjacent to spinal fu- sion surgery." is definition distinguishes the device from thoracolumbosacral pedicle screw systems that are used in other regions of the spine. 2. e FDA developed the final rule based on a recommendation from the Orthopaedic and Rehabilitation Devices Panel and accepted pub- lic comment on the proposed rule. e agency expects its final rule to assure device safety and effectiveness. 3. Manufacturers of posterior cervical screw systems are now required to develop devices with special controls, including: • A design with consistent geometry and material composition for intended device use. • Demonstrated mechanical function and durability in nonclinical performance testing. • Biocompatible device components. • Demonstrated cleanliness and sterility in validation testing, or the ability to clean and sterilize the device. • Clear technological features description, intended use indications, device-specific warnings and contraindications on the device label. 4. e FDA estimated the final rule could im- pact 32 device manufacturers that develop 38 products. 5. Companies that manufacture posterior cervi- cal screw systems will likely see a one-time cost of $78.69 to read and understand the rule as well as a $13,189 one-time cost per project for labeling. e agency estimated the total cost of the rule at $503,700. n Louisiana neurologist allegedly defrauded government of nearly $1.7M By Angie Stewart L ouisiana neurologist Anil Prasad, MD, was charged with conspiring to dispense controlled substances and commit healthcare fraud, according to the Department of Justice. From 2016 to 2018, Dr. Prasad allegedly pre-signed prescrip- tions for controlled substances, including oxycodone, for pa- tients he didn't personally examine. The prescriptions Dr. Prasad signed without examining patients to determine medical necessity cost Medicaid about $1.1 mil- lion and cost Medicare nearly $594,000. Dr. Prasad also allegedly pre-signed prescriptions for controlled substances while he was traveling abroad. Two nurse practi- tioners and the owner of the clinic where he worked are listed as co-conspirators in the indictment, but they're all unnamed. Authorities said Dr. Prasad was aware that some patients paid for the unnecessary prescriptions using their Medicare Part D and Medicaid benefits. n Visit HawkeyeTI.com for product videos and information Hawkeye Ti TM 3D PRINTED TITANIUM VBR IMPLANT DEVICE Choicespine presents tm Choicespine presents 3d Printed Titanium 510(k) clearance Built-in 8° Lordosis

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