Orthotics list: 'Double-edged sword'

BALTIMORE - CMS last month released a list of off-the-shelf (OTS) orthotic codes, and it's a good news-bad news scenario, say stakeholders.

The good news: The list clarifies what CMS considers to be OTS orthotics. Providers aren't required to have special certification for OTS, as they do for custom items.

"It's never been put in writing, and for providers, it depends on who they talk to if they can provide it or not," said Kelly Wolfe, CEO of Regency Billing and Consulting. "(Providers) will feel some comfort level knowing that they can provide them."

CMS announced last week that it would accept comments on the list until March 16, instead of March 8. It released the list in response to confusion within the industry over which products have to be provided by certain qualified individuals.

The bad news: OTS orthotics is one of the categories that could be subject to competitive bidding, although it was not included in Rounds 1 or 2."It's a double-edged sword," said Wolfe. "They could either be considered OTS and subject to bidding or they could be on the shelf and then they would have to have the certification."

The list contains about 60 codes for items that require "minimal self-adjustment," as defined by law. Stakeholders at press time were still reviewing the list, but they expressed concerns that some items on the list should be considered custom devices, not OTS, and therefore, should only be provided by certified orthotic fitters or orthotists.

"An individual supplying these items should be knowledgeable and competent in measuring, fitting and adjusting as required," said Claudia Zacharias, president and CEO of the Board of Certification/Accreditation, International. "It would appear that many of these items do not meet the statutory definition of 'minimal self-adjustment.'"

The list seems simple enough, but there's a lot at stake. When an orthotic device isn't properly fitted, it can cause problems for the patient, said Zacharias.

"Our major concern is that an ill-fitting orthosis won't provide a positive result, and can even cause the exacerbation of a current condition or secondary complications requiring additional medical or surgical treatment," said Zacharias.

BOC, as a member of the O&P Alliance, has met with CMS to discuss the list. The O&P Alliance is a coalition of national organizations that represent orthotics and prosthetics.