On July 27, the Centers for Medicare & Medicaid Services (CMS) posted a final decision memo for Independence Technology’s iBOT® 4000 Mobility System. According to the memo, CMS concluded that the device meets the definition of durable medical equipment, but that the evidence was lacking to conclude that the 4-wheel, balance, stair and remote functions met the definition of DME under Section 1861(n) or that these functions offer clinically significant benefits in mobility-related activities of daily living.
“While Medicare reimbursement covers the iBOT 4000 as a power wheelchair solely based on the mobility system?s standard function, we are disappointed that coverage of the iBOT 4000?s four other functions is not included — balance, stair, 4-wheel and remote — in the NCD,” said Gregg Howard, vice president of sales and reimbursement, Independence Technology, Endicott, N.Y. “CMS considers these functions to be accessories for the iBOT although these functions are completely integrated into the device. We believe the integration of these functions on the iBOT 4000 helps to not only medically improve the lives of people with disabilities inside of the home, but also improves their ability to participate in mobility related activities of daily living.”
Howard rejected CMS’ claim of inadequate clinical evidence on the four functions of the device. “The safety and efficacy of the iBOT Mobility System are well established based on clinical results and product testing,” he said.
The iBOT 4000 Mobility System, a battery-powered mobility device, relies on a computerized system of sensors, gyroscopes and electric motors to allow indoor and outdoor use on stairs as well as on level and uneven surfaces. Several functions offer unique options for end-users including a standard function that provides mobility on smooth surfaces and inclines at home, work and in other environments; a 4-wheel function that provides movement across obstacles, uneven terrain, curbs, grass, gravel and other soft surfaces; a balance function that provides mobility in a seated position at an elevated height; a stair function that allows for ascent and descent of stairs, with or without assistance; and a remote function that assists in the transportation of the product while unoccupied.
On Jan. 26, 2006, CMS opened an NCD to evaluate coverage of the iBOT 4000 in response to a formal NCD request. Two public comments periods ended on March 6 and May 30, respectively. Of the commenters, 97 percent supported coverage of the iBOT 4000 under the DME benefit.
Many commenters supported coverage of the iBOT 4000 under the DME benefit category and under a new benefit category entitled “Interactive Balancing Mobility System.” Commenters objected to CMS separating the features of the device as part of its coverage decision. According to CMS, commenters reported that the device would improve the life, well-being and independence of many stroke survivors as well as benefit individuals who live in homes where floors are separated by a flight of stairs or several steps. Users and family members and acquaintances of the iBOT 3000 and 4000 reported the device assisted them or had the potential to assist them to reach their cabinets or closets, go up and down stairs, have an eye-level conversation, attend community activities outside the home, work in their yards and obtain employment.
Of the commenters, four opposed the coverage under a new benefit category, expressing concern that other medical equipment on the market provides standing, reaching and seat elevation functions not covered under Medicare.
Independence Technology plans to continue working with CMS and other payers on reimbursement for the device.
Check out the decision memo at www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=5#dm.