1. Why is it important for me or my organization to comment on Medicare coverage of the iBOT? (To submit comments, click on the following link: http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=5).

The iBOT Mobility System will greatly improve the functional status and quality of life of people with disabilities who require its unique functions. But even for those who don’t need wheeled mobility, achieving coverage of the iBOT could lead the way toward coverage of other assistive technologies like assistive hearing aids, vision technology, speech generation devices, advanced prosthetic limbs, functional electrical stimulation devices and a host of emerging technologies that will benefit people with disabilities. Without adequate health care coverage, many of these devices will never become accessible to people with disabilities.

2. But I’m not covered by Medicare and my organization’s members usually aren’t either? What impact will this decision have for the non-Medicare population?

The Medicare program is the largest federal payer of health care services in the country. Many private insurers and other public programs look to the Medicare program when determining what they will cover. Coverage under Medicare has a ripple effect that will make this device more accessible to anyone with health insurance, not just Medicare beneficiaries.

3. But Medicare covers the elderly and this device seems more appropriate for younger people with mobility disabilities.

Medicare covers over 6 million people with disabilities under the age of 65, many of whom become eligible for Medicare because of work-related disabilities. A significant portion of these people have mobility impairments and some might be able to return to work with the use of devices such as the iBOT.

4. Isn’t the iBOT just a fancy power wheelchair?

No. In fact, the FDA determined that the iBOT is a “Class III medical device,” when all other manual and power wheelchairs are labeled “Class II.” This means that a sister federal agency to CMS viewed the iBOT as unique, and in fact it is. No wheelchair currently exists that performs all of the iBOT’s functions, integrated into one portable mobility device.

5. What will happen if CMS decides to cover the iBOT as a power wheelchair with added features (e.g., stairclimbing, etc.)?

This seems to be where Medicare may be headed and if this is CMS’s final coverage decision, it will effectively mean that Medicare beneficiaries will not have access to the device. In this event, Medicare would pay only a small portion of the cost of the device and leave the beneficiary with an unrealistic financial burden.

6. How can the “power wheelchair function” of the device be separated out from the other functions when the device is one integrated system?

It can’t. CMS has suggested in the past that the iBOT’s standard power function is considered covered durable medical equipment (“DME”), but that the stairclimbing and other functions unique to the iBOT are non-covered DME benefits under the program. They seem to be artificially separating one integrated device into component parts and suggesting coverage for only the most commonly available function, standard power function. The device is either DME or it’s not, and that depends on whether it meets the four prong definition of DME.

7. What is the definition of DME under Medicare?

To be considered DME under the Medicare program, an item must (a) withstand repeated use, (b) be primarily medical in nature, (c) not be generally useful in the absence of an illness or injury, and (d) be used in the patient’s home. The iBOT, with all of its functions combined into one device, squarely meets this definition.

8. Well, if the iBOT meets the four prongs of the DME definition, why is it even necessary for CMS to make a Benefit Coverage Determination?

It probably isn’t, but CMS is asking for comments about this anyway. Unless they hear strong opposition from the public about their likely intention to cover the iBOT as a power wheelchair but not cover the stairclimbing and other unique functions of the device, CMS will likely take this path. This would effectively be a determination of non-coverage for the iBOT.

9. Why doesn’t CMS consider stairclimbing, for instance, to be a covered benefit?

CMS has stated in the past that because stairway elevators, which are essentially fixed, home modifications, are not covered by Medicare, that the stairclimbing function of the iBOT may not be covered either. This seems like a big stretch and fails to take into account the fact that the stairclimbing function is embedded in the portable device itself. The iBOT’s stairclimbing function allows the user to climb many different flights of stairs, whether in the home or elsewhere.

10. Does Medicare cover any services related to stairclimbing?

Yes. CMS covers rehabilitation therapies to train Medicare beneficiaries (who are capable of walking or have the potential to walk) how to climb stairs in their homes following an illness or injury. But Medicare apparently does not cover services aimed at achieving this same function for beneficiaries who have no potential to walk. To provide a benefit to ambulatory patients and deny essentially the same benefit to non-ambulatory beneficiaries suggests a discriminatory impact of these coverage policies.

11. How does coverage of the iBOT fit into the new National Coverage Determination for Mobility Assistance Equipment (“MAE”)?

The new coverage rules for MAE state that a beneficiary with a mobility impairment must be able to state that their home or “typical environment” is accessible to traditional wheelchairs before one will be covered. If a person’s home cannot accommodate a traditional wheelchair, the beneficiary will be denied access to a wheelchair entirely. This is where the iBOT NCD requests CMS to consider covering the device. In this way, the iBOT could offer a valuable alternative to beneficiaries who are at risk of receiving no wheeled mobility at all, despite their need.

12. On what issues does CMS really want public comment?

The first decision they must make is known as a “Benefit Category Determination.” In order for Medicare to pay for anything, it must be considered a “covered benefit.” CMS has two options. They are trying to decide whether this innovative device: (a) should be considered a power wheelchair with a number of add-on features (for example, stairclimbing); or, (b) should be considered a new category of “durable medical equipment” known as “Interactive Balancing Mobility Systems” which would describe a device that integrates a whole range of functions that power wheelchairs are not capable of performing. The iBOT NCD request seeks option (b).

13. Doesn’t CMS want comments on whether to cover this device for Medicare beneficiaries?

They do. But before they can even get to the question of whether it is “reasonable and necessary” for certain beneficiaries, they need to decide whether it is considered a covered benefit. For instance, for years prescription drugs were not considered covered benefits under Medicare so the program did not cover them until the law changed. CMS needs to decide whether the iBOT, with all of its functions integrated into one device, meets the four prong definition of “durable medical equipment.”

14. What is the second main issue on which CMS is looking for public comment?

Whether the iBOT™ Mobility System is “reasonable and necessary” for Medicare beneficiaries most in need of its functions. In CMS’s terms, this is called a “National Coverage Determination.” In other words, Medicare would like public comment on whether it should cover this device for a defined group of Medicare beneficiaries with mobility disabilities, particularly those people whose homes or “traditional environments” (as the NCD for MAE states) are not accessible for traditional wheelchairs.

15. Does the cost of the iBOT factor into the question of whether it is reasonable?

Yes. The iBOT is not an inexpensive device and is clearly not for every Medicare beneficiary who wants one. It would only be reasonable for a beneficiary who truly needs its extensive functions and where no other reasonable alternative exists. To put the iBOT in perspective, the cost of the device is not out-of-line with the cost of current high-end wheelchairs, advanced prosthetic limbs, and a host of inpatient surgical procedures and hospital stays for a variety of conditions.

16. Aren’t I being asked to support a product from a specific manufacturer?

Yes and no. Yes, because the iBOT is a unique device and no other manufacturer has developed a way to achieve the same functions in one device. No, because the NCD request is for CMS to create a new category of DME called “Interactive Balancing Mobility Systems,” much like “Power Operated Vehicles” or scooters. Innovative technologies usually come to the market with one owner before similar products are able to compete.

17. Can’t everyone with a mobility impairment benefit from the iBOT and won’t this flood CMS with requests to cover the device?

While many people could benefit from the iBOT, there is a relatively small subset of Medicare beneficiaries who will be able to demonstrate that they both require it, and are capable of safely and effectively using the technology.

18. What are the typical types of beneficiaries who will benefit from the iBOT?

Potential iBOT users must undergo an extensive clinical evaluation and training administered by independent therapists to ensure they are capable of safely operating the device. Clinical trials on the iBOT indicate that high functioning power wheelchair users and low functioning manual wheelchair users are able to maximize their functional status with the iBOT.

19. What about other payers? Does anyone else cover the iBOT?

Yes. The Veterans Administration has developed specific coverage criteria for the iBOT and a number of veterans currently use them. If veterans have access to the iBOT, why shouldn’t Medicare beneficiaries have similar access? Similarly, at least two state Medicaid programs have agreed to cover the iBOT and New Jersey has developed specific coverage rules. Some private payers are also apparently covering the device.