The Patient Protection and Affordable Care Act passed and became active as of 2013. There is an additional 2.3% of tax on the sale of all medical devices. The FDA assigns a product code to medical devices, which would list it as medical or not. In general, the FDA requires a device defined in section 201(h) of the FFDCA that is intended for human medical management to be a part of the group. Oddly, biological devices don’t seem to count, but devices that are not intended for humans (such as sterilization equipment) do count. Included devices are:
- Nitrous and oxygen delivery systems and gas
- Computer equipment used for diagnostic purposes
- X-ray equipment, sensors, cone-beam CT systems, caries detection devices, and cameras
- Surgical equipment
- Handpieces
- Replacement parts
- Remanufactured or refurbished equipment
- Instruments
- Imaging equipment
- CAD/CAM machines
- Prosthetic devices
This impacts privately run medical practices the most, especially those that don’t focus on holistic businesses (since they are unaffected). Dentists mostly fall into this category, and it can put an unnecessary strain on dentists, since single devices often cost 2000 or more dollars. The majority of Dentists are looking at this as something that needs to be passed on to patients as fees- which is an issue, as many patients feel the prices at dental offices are already too high. A bigger risk is that doctors will simply take longer to upgrade their equipment and will use less cutting edge technology- something that will stifle innovation and prohibit new products from entering the dental realm very easily. This is not something I think that should be thought of lightly, as I often enjoy learning about new dental technology and the innovations in the dental world. Time will tell the long term effects on this change.