Last week, the Medicare program released a draft coverage decision for the iBOT Mobility System that essentially amounts to a non-coverage decision for the device.

Rather than recognizing the device as an integrated, multi- functional system, Medicare artificially split the functions of the iBOT Mobility System into component parts. The Centers for Medicare and Medicaid Services (CMS) determined that only the iBOT Mobility System's "standard power function" meets the Medicare definition of "durable medical equipment" while its other functions such as stairclimbing, 4-wheel function, and the balance feature to extend reach are not considered covered benefits.

Despite over 100 public comments that Medicare should not take this approach, CMS's draft decision takes this position. As a result, getting Medicare to cover this innovative device at all will be extremely difficult and if it is covered, the beneficiary will have to pay for most of the device out-of- pocket, putting it out of reach for most beneficiaries.

CMS is soliciting public comment on the proposed coverage decision until May 26, 2006. The ITEM Coalition is encouraging individuals and organizations to submit comments and are offering the below "talking points" to get you started. If your organization plans to submit comments, please let us know. The comments can be as short or as long as you please, but CMS needs to hear from you by the deadline. If you would like assistance drafting your comments, we would be happy to help. Submit your comments anytime between now and the 26th of May.

Talking Points for the iBOT Mobility Device:

1. The iBOT is a single, integrated device with functions that cannot be broken apart and covered separately. This is not a power wheelchair with "add-on" features, just as a power wheelchair is not a manual wheelchair with "add-on" features.
   
   
2. The iBOT meets the definition of DME and, therefore, CMS should establish a new benefit category for "Interactive Balancing Mobility Systems" such as the iBOT Mobility System.
   
   
3. Just because the iBOT is DME does not mean that it will be "reasonable and necessary" for every Medicare beneficiary who can benefit from it. CMS should develop specific criteria to determine who will qualify for the iBOT Mobility System and who will not.
   
   
4. The functions of the iBOT that CMS states are not considered "covered DME" (i.e. stairclimbing, extended reach/seat elevation, 4-wheel function) are critical for some beneficiaries to achieve, especially those whose homes are not accessible to traditional wheelchairs. The iBOT is a solution to this problem and should be considered before the beneficiary is provided no mobility device at all.
   
   
5. CMS is holding the iBOT Mobility Device to an unrealistic standard when it says that "published clinical evidence" is required to demonstrate that the iBOT improves a "personal mobility deficit" that impairs the ability to perform daily activities. This is obvious on its face. The iBOT underwent extensive clinical and non-clinical testing before being approved by the FDA. If CMS' standard for coverage were to be applied to existing wheelchairs and scooters, Medicare would cover none of these devices. People with disabilities don't need peer-reviewed, published clinical trials to know that stair climbing, improved reach, and 4-wheel function can assist them in performing their daily activities.
   
   
6. If CMS insists in applying this same standard to all new assistive devices for people with disabilities, Medicare will cover no new devices or technologies for people with disabilities. The draft iBOT decision is a threat to access to all assistive technology in the future.
   
   
7. Medicare covers therapies and devices that improve the ability to climb stairs and improve reach and mobility for beneficiaries who have the potential to walk. But they are denying coverage for a device that provides the same benefits to beneficiaries who are not capable of walking. This is inequitable treatment and there is no basis for treating these groups differently.
   
   
8. The Veterans Administration believes that the iBOT Mobility System's functions are of medical benefit to veterans with disabilities and has created specific coverage rules for the device so that only those who need it have access to it. If veterans have access to this life-changing technology, Medicare beneficiaries should have no less access to this device.
   
   
9. CMS's coverage decision on the iBOT, if finalized as is, will not only prevent Medicare beneficiaries from receiving the iBOT Mobility System, but will likely deny access for many people with disabilities with private health insurance, as many private insurers take their coverage cues from the Medicare program.
   
   
10. The iBOT Mobility System represents innovation and new technology for people with disabilities. A final coverage decision that denies access to Medicare beneficiaries will send a clear message to innovators, manufacturers, consumers and all other stakeholders, that investments in assistive technology to assist people with disabilities are not worthwhile.
    
    
11. We strongly urge CMS to reconsider its Proposed Decision Memorandum on coverage of the iBOT Mobility System and issue a final coverage policy that grants reasonable access to this item of durable medical equipment by establishing a new benefit category known as "Interactive Balancing Mobility Systems," of which the iBOT Mobility System would be the first device to be covered.
    
    

The ITEM Coalition's purpose is to raise awareness and build support for policies that improve coverage of assistive devices, technologies and related services for people with disabilities of all ages. More information can be found on the ITEM Coalition website. As always, we thank you for your advocacy and please contact us at (202) 349-4260 with any questions or if you need assistance.