Despite the approval given by the government, the insurers can refuse to cover a given device. This was emphasized by the case of Linx, a new medical implant for treatment of severe acid reflux. The device was approved by FDA about 3 years ago and is reimbursed by the Center for Medicaid and Medicare Services (CMS). However, most medical insurance companies still refuse to cover for this device citing lack of evidence for effectiveness. It does not seem that the manufacturer of the device published the Pharmacoeconomic analysis to support the use of this device. Pharmacoeconomic data demonstrates the financial superiority of using a given product over standard of care. This data shows that by using a given product, the overall cost of management of a given disease is reduced compared to treatment with other available options. This information is critical to support reimbursement by CMS and is used to negotiate coverage by insurance companies as well. Lacking such data, the insurance can steer patients towards standard of care. In this case, for example, data showing implantation of Linx reduces the need more expensive disease management of ulcers and other effects of severe acid-reflux. The manufacturer is in discussion with medical insurance companies and most likely is making that case. Their life would have been simpler and more profitable had they started at the same time they sought CMS reimbursement.
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