The explosive growth in the use of implantable medical devices has been accompanied by an alarming increase in the number of adverse events and recalls, especially in Class III devices, those that are life-sustaining and provide the greatest potential risk. In the first quarter of 2018 medical device recalls increased 126% to 343 devices representing 208.4 million units.
Those patients using medical devices who have multiple chronic conditions and are taking multiple medications simultaneously pose even greater challenges, representing an unacceptable level of financial, health, and safety risk to payors and patients. A new model to evaluate the comparative effectiveness, safety, and reimbursement of implantable medical devices is needed.
FORMULARY PREDICT is the first commercially-available formulary for implantable medical devices. It will provide healthcare payors with the ability to assess the clinical appropriateness, risk, and cost of medical devices delivering benefits even greater than those derived from pharmaceutical formularies. FORMUARY PREDICT leverages machine learning and decision intelligence models to using massive amounts of data from the FDA, CMS, and client-provided claims to provide deeper understanding about the interaction of implantable medical devices in patients afflicted with multiple medical conditions taking multiple medications simultaneously.