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By Jennifer Garvin

New policies adopted by Align Technologies, Inc., have spurred sharply worded complaints from ADA members who say the policies are unfair to dentists who use the company's Invisalign system.

As part of what the company calls a "proficiency program," Align is requiring all its system users to start at least 10 cases and complete at least 10 Invisalign-specific continuing education credits per calendar year or lose their status as active providers. Align's new policies took effect June 2.

Dentists who fail to comply with the new requirements could reactivate by retaking Align's Invisalign Clear Essentials I training course, offered at tuition ranging from $1,600 to $1,900. Reactivated dentists then would have to meet the program proficiency requirement for the calendar year.

"I believe it is unfair for Align Technologies to unilaterally change the terms of our agreement," said one member in an e-mail to the Association. Added another, "As a provider, I should have the freedom to use any treatment" without "a big company telling me that I have to at least put in 10 cases a year."

Among dozens of calls and e-mails to the ADA, some members questioned the ethics of imposing yearly minimum case starts—quotas that seem to pressure dentists into treatment plans related to a product rather than to the best interests of their patients.

Since the new polices were announced, the ADA has been in contact with Align officials to let them know about the membership's reaction to the changes and to explore the thinking behind the new policies. (It should be noted that, under the law, companies have a great deal of latitude in establishing minimum purchase requirements.)

"We've heard from members who note that the current economy is making it difficult for them to meet these new case requirements," said ADA President John S. Findley. "Some said they had performed many cases over several years but were not on track to meet the minimum case requirement this year—and they questioned the value of retaking Align's introductory class."

In a June 16, telephone conversation with Align officials, the company declined to make allowances for individual circumstances, such as local economic conditions or a practitioner's previous case experience with Align.

The company claims the new program is intended to ensure "product proficiency," which it says is not the same as a standard for clinical proficiency. This new protocol, the company said, is not based on a clinical review of actual oral health care outcomes. The company also pledged to assist dentists who say they can't get enough cases by teaching them marketing strategies.

The Association followed up with Align on June 24. On the phone for Align were Dan Ellis, vice president for North American sales, Shannon Henderson, corporate communications, and Randy Golden, senior counsel. Mr. Ellis did most of the talking for Align.

"We understand that this is a significant change," he said. "The goal here is to bring everyone along together and not to penalize or punish." He said he was "not surprised" by negative reactions to the firm's new policy but claimed the company was also hearing from dentists responding positively to the change. Asked whether adoption of the new policy was largely a marketing decision, Mr. Ellis replied that it was not.

To read Align's news release on the matter, visit "http://vip.invisalign.com:80/proficiency/".

In a report to shareholders earlier this year—the company's 10-K 2008 Annual Report—Align advised "enhancing the customer experience" as a way to improve sales.

"Specifically," the report states, "we are focused on improving our pre-selection process in order to attract new doctors that are motivated to become Invisalign providers and committed to making Invisalign a key part of their practices and strengthening our training programs in order to increase the rate that these newly trained customers submit Invisalign cases, as well as increase the rate that they move up the adoption curve to ultimately become leading Invisalign providers, or what we call promoters."

ADA leaders expressed deep reservations about such an approach to patient care.

"The choice of any treatment modality should be based on a patient's needs," said Dr. Frank Graham, chair of the ADA Council on Dental Practice and an orthodontist. "Clinical judgment cannot be manipulated by quotas or financial incentives."

Dr. Mark Ritz, a general dentist and CDP vice chair, added, "I am certainly skeptical of the validity of pushing the continuing education. It seems like they're trying to make cheerleaders of those who have 10 cases rather than protecting the public and ensuring the quality of care."

It is not yet known how many members have been affected by Align's change in requirements. Cleveland-based Northcoast Research, an independent research firm, recently surveyed 50 current Invisalign providers and found that 39 of them said they do fewer than 10 Invisalign cases per year. What's more, 35 of those 39 said they did not expect to make the new case requirements. Only 10 of those surveyed said they expected to do 10 or more cases annually. Align officials say the change in policy was aimed at helping to ensure that Invisalign-trained dentists have the experience needed to achieve high quality treatment using the company's products. In other words, they reason, the more a dentist performs a procedure, the more proficient he or she becomes.

"It's been apparent for a long time that we needed to figure out how to balance the representation of [a dentist] who does thousands of cases vs. a couple," Mr. Ellis said. "We recognized this is a skill-based procedure, and we finally got to the spot where we had an obligation to the consumers we all serve, the doctors and the company."

For members seeking additional information, the ADA has prepared a fact sheet that can be accessed online at "www.ada.org/goto/invisalignfactsheet". Members may also contact Dr. Pam Porembski, senior manager, ADA Council on Dental Practice using the ADA's toll-free line, Ext. 7463. She can be reached by e-mail at "porembskip@ada.org".