Independence Technology Requests National Coverage Determination for iBOT

Independence Technology, a Johnson & Johnson Company, has filed for a National Coverage Determination (NCD) with the Centers for Medicare & Medicaid Services (CMS) on behalf of its famous stair-climbing iBOT power wheelchair.

In response, CMS has opened a 30-day public comment period starting Jan. 26, 2006, according to documents posted on CMS' Web site. Independence Technology has sent out letters encouraging recipients "to view a copy of the (NCD) request and to submit a brief statement about your support for the iBOT and for innovation for people with disabilities."

The iBOT power chair, with gyroscopic technology that enables it to rise and balance on two of its four wheels, is in its second incarnation: The iBOT 4000 was introduced last year to replace the original iBOT 3000. The iBOT is currently sold directly to consumers following assessment and training by rehab clinicians, and is serviced by Independence Technology technicians. In addition, the Food & Drug Administration's (FDA) original approval of iBOT carried with it certain restrictions and user criteria, including a user weight of no more than 250 lbs. (289 lbs. for the 4000 version), the ability of the user to use a standard footrest and sit upright in a standard wheelchair, functional use of at least one arm and no need for a ventilator or pressure relief via tilt or recline positioning systems.

Lead CMS analyst Linda Smith confirmed that Independence Technology has "followed the NCD criteria process, and we reviewed the application. Our next step ù which is where we are ù was to post a tracking sheet for public comment. They followed all the procedures, to make sure they had all the evidence to support it (the NCD request)." Smith said CMS is now waiting for public comments: "A lot of times through the comments, we may get additional research (as) different groups provide comments."

To see the coverage documents for the iBOT 4000, go to www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=5.

Among the obvious questions raised Independence Technology's NCD request is the very reason for the request. Examine the coverage documents, and you'll see that Independence Technology is calling the iBOT not a power wheelchair, but "an interactive balancing mobility system." Independence Technology Reimbursement Manager Elizabeth Patience confirms that the healthcare giant is seeking a new NCD to cover what it considers to be significant and new technology.

"It's really the integration of the device, as well as the unique features," Patience says, in explaining why Independence Technology believes a separate iBOT NCD is appropriate. "It's not only that there's not a current code that covers stair climbing or the balance function or even the four-wheel function. But it's the integration altogether: the ability to transition between one and the other as you encounter obstacles. It's about the integration of the device. And CMS has indicated that they feel it's sort of a power wheelchair with some accessories that they don't otherwise cover. Since you can't strip the iBOT apart (to remove those accessories), the current coding wouldn't work."

"Integration" definitely seems to be the buzzword of the NCD effort. Independence Technology is maintaining, for instance, that ù unlike the seat elevators that are optional and can be removed from many other power wheelchairs ù the iBOT's ability to elevate is an integral part of its self-balancing, gyroscopic technology. Integration is also an advantage that iBOT has over multiple pieces of mobility equipment, Patience says.

"If you hit a curb (while in the iBOT), you don't have to get into another device," she explains. "There are stairway elevators, but they're fixed to one location. You might have one at your house on your front staircase, but you don't have (an elevator) on your back staircase. So you can take this (the iBOT) with you anywhere and overcome the obstacle as you encounter it. So that's an argument that, when (CMS) compared (iBOT) to a stairway elevator, I think they failed to consider how it affects all stairs."

CMS' shift last year from "bed or chair confined" to functional, mobility-related activities of daily living (MRADL) criteria to determine power mobility coverage for beneficiaries could prove to iBOT's advantage.

"The new focus of CMS on mobility assistive equipment (MAE) is on improved functionality," Patience says. "If you say that someone needs a device to eat, but they can't reach the burners on their stove, or they can't reach into their freezer or they can't get to the kitchen counter, then have you really improved their functionality?"

Of how the iBOT assists with mobility activities of daily living, Patience says as an example, "The device might not help you take a shower, but it's going to help you pull things out of the medicine cabinet, it's going to help you get stuff off the closet shelves, it's going to help you get clothes in and out of the dryer. These all impact grooming."

The new emphasis on achieving functionality with power mobility equipment, Patience says, may also point to iBOT as a possible solution in certain home environments. "If you've seen the algorithm that (CMS) came out with in May on mobility assistive equipment and how they make the decision, whether you go from a cane to a crutch to a walker to a manual chair to a power chair ù box number six on that is about whether your environment supports a wheelchair/wheeled mobility. We asked them about that, if that included like if you have stairs in your home, then the iBOT would be appropriate. And that's what our NCD argues. They told us that if you have stairs in your home, then wheeled mobility might not be appropriate for you. Which is ù we've been using the word as sort of inhumane, when you think about that. So that if someone has stairs in their home or their home is not really wheelchair friendly, that they would get nothing.

"We're arguing that instead of having the MAE algorithm and if your home is not accessible for wheeled mobility, 'no' means you get nothing ù instead of 'no' means you get nothing, 'no' sends you into 'maybe an iBOT's appropriate.' And looking at that subset of maybe the iBOT's appropriate and iBOT would help you get around and do your functional activities of daily living."

Historically, of course, Independence Technology is not the first manufacturer to offer seat elevation on its power chair ù and historically, seat elevators have routinely not been funded by Medicare. Asked if Independence Technology is concerned about that less-than-stellar reimbursement history, Patience says, "(Seat elevators have) not been an integrated part of the system, and it hasn't been available, I believe, where you can move at that level ... I'm less familiar with that, but the idea again is are you looking at it from a functional perspective and the ability to overcome obstacles as you encounter them?"

Several power chair manufacturers contacted for this story either declined comment or were not immediately available for comment, but Invacare's Mark Sullivan confirms that Invacare's power wheelchairs can in fact be driven at reduced speeds while the seat is in the raised position (as can other currently available power chairs with seat elevators, according to literature from assorted manufacturers). Sullivan adds that a reduced driving speed while a seat is raised wouldn't seem to be a hindrance to such tasks mentioned by Patience, such as reaching closet shelves, because such tasks don't appear to require a faster chair speed to accomplish. "Most manufacturers' (chairs) reduce to about 20 percent of your speed, which is really all you need when you're talking about getting a little bit closer to the sink," Sullivan points out.

As far as a push to urge Medicare to fund seat elevators, Sullivan says, "I'm not sure an iBOT should get its own code, but certainly, especially with the new power mobility regulations talking about the ability to perform MRADLs, one of the features that allows people to perform those almost better than anything else is seat elevation."

Asked whether Invacare has received any indication from CMS that it may be changing its negative funding stance on seat elevators, Sullivan says, "We have not had any indication on that. I do know the Clinician Task Force and the NRRTS (National Registry of Rehab Technology Suppliers) groups are actively trying to pull together more clinical information to try to get them to cover (seat elevation). There are two technologies out in the marketplace right now that essentially do what the iBOT is asking for, and that's seat elevation and then also there are some power chairs that do standing. I think they both accomplish the same thing ù seat elevation is probably preferred simply because just about everybody if not everybody can use seat elevation because you don't change your body position. With standing, you can't have any contractures; the body's got to be able to straighten out."

Sullivan does see a definite benefit to all the discussion that the iBOT has created with its NCD request: "The one nice thing is that hopefully it will bring attention to that particular improvement, in terms of doing the MRADLs ... However you achieve it, your ability to change your seat-to-floor level for performing the MRADLs is, I think, very important for people's independence."

Independence Technology, says Patience, is also working with the ITEM Coalition to urge Medicare coverage for mobility equipment used outside the home. Independence Technology mentions how iBOT enables users to venture outside their homes and into their communities to perform such "daily living activities" as "accessing the pharmacy, a doctor's office, the grocery store or attending religious services" in a new release that detailed the iBOT's NCD request.

Patience says, "Absolutely, we're questioning it," when asked about Independence Technology's stance on the in-the-home requirement, but adds, "It isn't changed yet, so we had to file the NCD with the in-the-home requirement." Independence Technology, Patience says, had been working on applying for an NCD for some time, but ongoing evolutions of CMS' power mobility policies made the manufacturer decide to wait "until all of that ended," she says. The iBOT 4000 also has a functional advantage over the iBOT 3000, Patience says: a 4" lower seat-to-floor height, which improves the 4000's ability to fit under tables.

Sullivan says he hasn't heard any buzz from Medicare about a possible change to its "in-the-home" coverage criteria: "I would love for Medicare to cover other features outside the home, in terms of speed (and ) the ability to climb curbs. But typically, they've said they're really only concerned with things inside the home."

Patience says Independence Technology has already had significant success in getting Medicaid, Veterans Administration and other sources of funding for iBOT, in part because other payors may have somewhat different beneficiary goals, such as enabling beneficiaries to rejoin the workforce.

And despite the Medicare NCD request, Patience notes, "We're more interested in the Medicaid population, the 6 million in Medicaid that are under 65 (years old), just from the standpoint of the contraindications for the device and the benefit of being able to take care of kids and go back to work and participate in community activities." In layman's terms, iBOT is generally considered too complex and full-functioned to be used by seniors with simple strength or stamina issues, while high-end rehab clients may not meet iBOT's physical requirements for safe operation.

"The market for us is significantly smaller than the whole Medicare beneficiary population," Patience says.

As CMS is fielding public comments on the NCD request, Patience says CMS is also taking comments on another related topic: technology. "They're filing this in both the benefit category and the national coverage determination, which they've told me they've never done before. So they're looking for comments on why this is a unique device ù to answer your initial question, which I think was 'Is this a power wheelchair?' They're looking for comments on that, as well as at the same time comments regarding coverage. And they will not have another comment period for coverage. So they're seeking coverage on both."

The public comment period ends Feb. 26, 2006.

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