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State Regulations for CBCT Machines?

posted in Cone Beam CT Imaging, en

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Dr. KW asks:

I am having difficulty finding out the state regulations for a cone beam ct machine. Does anyone know what is involved in getting a CBCT and what is required for the state regulations or approvals needed to use it (I am in CT, by the way)? I have not been able to find a set of laws or guidelines anywhere. I have been told that it cannot be used in a dental office and requires a radiologist to read every scan. Is any of that true? Do different states have different regulations? I would appreciate any help.

5 Responses to “ State Regulations for CBCT Machines? ”

• Alan Winter, DDS April 29th, 2008

  
  

  Cone beam CT machines are dental devices approved by the FDA. As such dentists can own them and install them in their offices. On a state level, some states mandate a certificate of need to purchase and install these machines in dental offices. Up until recently, both Michigan and Connecticut required this, but I am certain efforts are being made to change this. With respect to requiring a radiology report, that’s a two-edged problem. OMSNIC, the oral surgeon’s malpractice carrier, just published recommendations in their quarterly newsletter stating that they felt radiology reports should accompany all 3D cone beam scans. So it may turn out that insurance carriers ask this of us going forward, in order to have our malpractice insurance cover us in case something is missed. Remember, dentists, by virtue of their licenses, are de facto radiologists. But can most of us interpret the expanded field of view on 3D images with a high degree of accuracy? That’s why teleradiology companies, like i-dontics, offers a radiology report by a board-certified oral & maxillofacial radiologist to all dentists. The other problem is that if you buy a CT machine and take scans for another dentist, your malpractice carrier will NOT cover you in case of a third party lawsuit. You need error & omission insurance for that. While it appears intriguing to get a CT machine and turn it into a business besides using it for your patients, there is lots to consider.

• David Mazza April 29th, 2008

  
  

  Contact the State Board, they would inform you about the requirements.

• Anon May 6th, 2008

  
  

  Additionally, you cannot “disclaimer” your way (ask for indemdification) out of your responsibility to diagnose what appears on the images. I see some companies issue a disclaimer for patients to sign indicating it is only for dental structures and the dentist is not responsible for anything else. This will not withstand legal scrutiny and the center and/or the dentist will be responsible for any failure to diagnose. I have a colleague examining two cases where masses were not identified on conebeam images by the dentists. Both dentists obtained “waivers of responsibility”, however motions for summary judgment based on those disclaimers were denied and the cases are moving forward. As such, if you’re considering conebeams, either have the cases read by a radiological specialist or refer the patient with the scan if anything is abnormal. The question you must ask yourself if you choose the latter, can you catch everything that is abnormal ?

• Dr. Dan Woodland August 20th, 2008

  
  

  If you are going to be scanning your own patients remember, did you send as many patients to an imaging site to be scanned prior to having a payment to make, states are looking into referring to yourself! Second check with your scanning facility to see if there if some type of a discount for your patients if you are sending a lot of patients, what you bill your patient for the scan may be different from the amount that the scanning center may charge the patient. $280,000 + additional insurance and person to run the ct scanner, depending on your state if you need a licensed CT tech for medical reimbursement (tmj…). Remember, as I have found out the hard way, the patient only has one pool of money, they may elect not to have implants in some areas at this time based on the fact they are also paying for a scanner which you own.. they are looking to negotiate (which who would belame them) you will do the scan for free, (Istill have a payment to make) or you will not be doing the implants! If I had sent to a scanning facility they would have known I am not getting additional money from them. By owning a scanner it has decreased my profit!!!!

• pmaloney13@sbcglobal.net September 6th, 2008

  
  

  I need to know if there are any hospitals in Illinois that can do a Cone Beam CT Scan. My daughter needs one and she is on Public Aid and cannot go out of Illinois. Please help.

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