Invisalign Proficiency Requirements

On June 2, 2009, Align Technology unveiled its new Invisalign proficiency requirements.  While these requirements claimed to regulate “product proficiency,” they alleged the desired results of improved clinical outcomes for patients.  Moreover, the requirements compel dentists to complete 10 hours of CE and start 10 patient cases each year to be permitted to use Invisalign.  The AGD was concerned that the latter requirement was unduly burdensome on the practice of dentistry. 

First, we were concerned that it imposed a new requirement on dentists who had paid for and completed Invisalign coursework in the belief that the coursework would be sufficient to incorporate Invisalign into their practices.  Second, we were concerned that the requirement was unrealistic especially in today’s economy; input from you, the members, have substantiated this concern.  Third, we were concerned the requirement interfered with the rights of state boards to regulate dentistry.  Fourth, we were concerned about anti-competitive or antitrust implications of a corporation imposing product-use requirements on the practice of dentistry.  Moreover, we were concerned that adding product-use requirements to the requirement of completing CE coursework may violate the language and/or spirit of PACE approval granted by the AGD per the PACE Guidelines.

On June 19, 2009, we asked our members for their input on this matter, and we asked that they share their input both with us and with Align Technology.  More than 1,500 of you responded directly to Align, and but for a small handful of you, you voiced your concerns with the new requirements. 

We listened to your concerns and, in July, 2009, we launched a deeper investigation into both the legality of the Invisalign guidelines and into Align’s compliance with the language and intent of the PACE guidelines.  The AGD PACE Council will be delving further into the latter issue at its council meeting on Oct. 16-17, 2009.

Moreover, in July, your President, Dr. David Halpern, requested the AGD Board’s direction for further action on this matter.  On July 21, 2009, per direction of the Board, Dr. Halpern spoke with Mr. Thomas Prescott, President / CEO Align Technology to request detailed background information in written form as a prerequisite for any further communication between the AGD and Align.

Mr. Prescott emphasized the importance of general dentistry to Align’s business and agreed to provide the requested information for the AGD Executive Committee and Board’s review.  On August 5, 2009, Align produced the requested information in the form of a letter to the AGD. 

While we appreciate Align’s time and effort to produce the letter, the letter confirmed that the requirement of 10 patient case starts was not scientifically based.  We were pleased however that Align recognized that there was no discernable difference in Invisalign product proficiency between general dentists and orthodontists. 

On August 7, 2009, the AGD Executive Committee reviewed Align’s letter and forwarded the communication to the AGD Board recommending a renewed commitment to opposing the Invisalign requirements, and to taking reasonable and necessary actions to resolve this matter and restore the sanctity of the doctor-patient relationship in making orthodontic treatment decisions.  

On August 28, 2009, the AGD Board also reviewed Align’s letter and agreed with the Executive Committee.  The Board crafted the AGD’s official response to Align, which was remitted to Mr. Prescott on September 4, 2009. 

The AGD understands the importance of this matter to the practice of dentistry, and will continue in its deliberation and permissible efforts to advocate on your behalf in this matter.  Further, we will keep you informed of any material updates as we move forward in this endeavor.