Senators address off-the-shelf orthosis guidelines in letter to CMS

Senators Chuck Grassley (R-Iowa) and Tom Harkin (D-Iowa) have challenged CMS for exceeding the language of the Medicare Modernization Act statute’s definition of “minimal self-adjustment” in its definition of off-the-shelf orthoses, according to a press release from the American Orthotic & Prosthetic Association.

The letter, addressed to Marilyn Tavenner, CMS administrator, states that “Congress unambiguously defined [off-the-shelf] OTS orthotics as orthotic devices that ‘require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit to the individual’ … CMS ventured beyond both the language and the intent of MMA Section 302” in the 2007 establishment of the final rule redefining minimal self-adjustment as “an adjustment that the beneficiary, caretaker for the beneficiary, or supplier of the device can perform …”

The senators conclude that the change in definition has led to inaccurate classification of many orthotic devices, which could result in “serious beneficiary harm.”

According to the press release from the American Orthotic & Prosthetic Association (AOPA), both Senators Grassley and Harkin were present when Congress drafted the original language in defining “off-the-shelf” and understand its intent. Grassley and Harkin have recommended a revision of the regulatory definition of OTS orthotics and a modification of the OTS list and codes.

“This letter is completely consistent with the comments AOPA submitted in the recent CMS OTS proposed rulemaking, along with over 500 parallel comments from AOPA members, their patients, and several other medical organizations,” the release stated.

The full text of the letter is available at

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