Will agreement dampen sales at Invacare?

ELYRIA, Ohio - It may be an uphill battle for Invacare to get new customers into complex power wheelchairs under an agreement it has with the Food and Drug Administration (FDA).

Industry sources say clinicians may have a hard time meeting a requirement in the agreement that they determine an Invacare wheelchair or seating system is medically necessary for a particular condition and can't be addressed by another manufacturer's product.

“There are some distinctions to Invacare products, and if a therapist has a good understanding of those distinctions, they will be able to justify the need,” said Laura Cohen, chairwoman of The Clinician Task Force. “But the average therapist doesn't.”

The agreement applies only to wheelchairs and seating systems that Invacare manufactures at its Taylor Street facility. But that's where it manufactures the bulk of its complex power wheelchairs for North America, including the TDX.

Invacare staff at corporate headquarters and territory business managers in the field are educating clinicians on product distinctions, such as Sure Step and Stability Lock, says Julie Jackson, director of the Mobility and Seating Business Unit.

“Today, many clinicians prepare the letter of medical necessity, which includes a detailed product description,” she said. “But, yes, the documentation requirements are completely new and there's an education process for all of our customers.”

As is often the case, providers have found themselves doing a lot of the grunt work educating clinicians on the new documentation requirements, they say.

“I carry the paperwork with me all the time and I say, 'I have to show this to you,'” said Gerry Dickerson, vice president of rehab technology for MedStar in College Point, N.Y. “I'm the devil's advocate. I ask them, 'Is there something overwhelming about the TDX that can't be provided by another product? If you answer this and this, we can move forward.'”

Invacare will have less of a hard time keeping current customers. When clinicians or physicians determine the same or newer version of an existing product is needed, they need only submit a form acknowledging the company's agreement with the FDA.