Regulatory Issues

Q – What is the FDA status of the device?

A –The MOD® device has been classified as a Class I device by the FDA, 510 (K) Exempt. The MOD® device can be found on the FDA website under the listing Establishment Registration & Device Listing or Product Classification: as a Dispenser, Solid Medication, Product Code NXB, Regulation Number 890.5050 and Registered Establishment Name, Avancen MOD Corporation.

Q – Does Avancen have a patent on the MOD® device?

A – The first MOD® device patent was granted by the United States Patent Office in 2006. To date there are five US patents issued on the device, the device medication tray and the device design.

Q – Does The Joint Commission (TJC) have to approve the use of the MOD® device?

A – TJC is aware of the MOD® device and has visited hospitals with the device in use; but the Joint Commission does not have regulatory authority to approve medical devices. As long as the facility maintains a policy and procedure for the safe use of the device, the device can be used with appropriate patients for whom a clinician order is written. The MOD® device is similar to an IV PCA, and policies must be generated to reflect the management of a PCA device.

Q – Does Medicare or Medicaid pay for the MOD® device and/or the medication trays?

A – When the MOD® device is used in the hospital, it is included as an expense of the patient’s hospital stay coded for charges as a piece of equipment used for patient care such as an IV pump or a ventilator. Therefore, Medicare and Medicaid will pay for the MOD® device as part of the bill from the hospital depending upon the Diagnosis Related Group (DRG) for the stay. For other insurance companies, the device is part of the overall bill and does not need individual approval by the insurance company. Medication trays that fit into the device are usually billed as a single charge for the entire tray similar to the billing for a multidose syringe loaded into an IV-PCA pump. From what we understand, most hospitals can only bill for the medications, whether for a PCA pump or an IV pump or the MOD® device.  The medication is charged for and the hospital effectively amortizes the cost of the delivery system as part of overhead in treating patients. This would be similar to the use of a Hoyer lift or bariatric commode.