CMS' decision on power | Fuzhou Island Fever Co.,Ltd

By Kerry Dooley YoungJune 5, 2023

This article is adapted from STAT's latest report, Decoding Medicare: 10 key coverage decisions and how they’re made.

For years, patients and medical groups have advocated for Medicare to cover wheelchairs with power-seat elevation, allowing users to, among other things, reach cabinets and countertops more easily and conduct conversations eye to eye.

In a major shift in its approach to the devices, the Centers for Medicare and Medicaid Services last month granted that request, saying it would cover some wheelchairs with a power-seat elevation feature. The agency said in its decision that the power-seat equipment could be considered part of Medicare's so-called durable medical equipment benefit, intended to cover products used in the homes and for repeated use.

"For too long, many people who use a power wheelchair could not access everyday items in their homes and may have struggled to get in and out of their device," CMS Administrator Chiquita Brooks-LaSure said in a statement about the decision. "This landmark Medicare decision to cover seat elevation is a major milestone that will improve the quality of life for so many who rely on this technology."

Advocacy groups welcomed the new policy. "This result exceeds our expectations and is being warmly embraced by the disability and rehabilitation communities," wrote Peter W. Thomas, the coordinator of the Independence Through Enhancement of Medicare and Medicaid (ITEM) Coalition, in a May 19 letter to CMS.

The ITEM Coalition includes both industry and consumer groups. The list of organizations signing the letter included the Medical Device Manufacturers Association and the nonprofit Medicare Rights Center, along with medical groups such as the National Multiple Sclerosis Society.

But the decision, issued on May 16, represents only a partial win. In 2020, the ITEM Coalition had made formal arguments to CMS for coverage of both power-seat elevation and power-standing for wheelchairs, citing medical evidence that the features were beneficial to the health and functioning of people in wheelchairs. Allowing people who use wheelchairs to achieve a standing position on a frequent basis, the ITEM Coalition argued, counters the medical complications associated with prolonged sitting, such as decreased range of motion, kidney stones, urinary tract infections, and reduced lung function.

CMS, in its decision, said it also intends to consider the standing features of wheelchairs in the future, without mentioning a specific time frame.

The coalition said it will continue to press CMS to cover power-standing features, as well as power seats.

"For individuals who spend large parts of their day in a seated position, the value of being able to stand, bear weight on the lower limbs, and allow gravity to aid in metabolic functions is well established in the clinical literature," Thomas wrote in the letter to CMS.

Still, the shift in Medicare's stance provided a good example of how CMS sometimes revisits its previous decisions, given new evidence and continued advocacy by patients and manufacturers, as STAT's latest report, "Decoding Medicare: 10 key coverage decisions and how they were made," explains.

In 2006, CMS had rejected a Johnson & Johnson request for coverage of the company's iBOT wheelchair. Priced at $26,100, the device could lift people to standing height and also climb stairs and curbs. In making its request for Medicare coverage, J&J had argued that the device had significant advantages over manual wheelchairs, power wheelchairs, and power scooters already covered by Medicare, which limited people to sticking with relatively flat, smooth surfaces.

"By permitting the user to negotiate variable surfaces, climb curbs and stairs, and ‘balance’ at a standing eye-level position (whether at rest or in motion), the iBOT Mobility System virtually neutralizes access barriers in the home as well as the community," J&J said in its request.

J&J had won premarket approval in 2003 from the Food and Drug Administration for the device, meaning it had cleared the highest regulatory hurdles for devices. But the company knew the request for Medicare coverage would be a tough sell at CMS.

Making a formal pitch for iBOT coverage in 2005, J&J had noted the challenges this request presented for CMS. The iBOT was "a breakthrough technology that does not easily mesh with conventional assumptions and expectations of mobility devices and the functional needs of beneficiaries," J&J wrote.

The company said CMS would need to create a new type of durable medical equipment category for the wheelchair, requiring distinct codes.

In turning down J&J's request in 2006, CMS said that the iBOT's seat elevation equipment and balance function could not be covered because they were not primarily medical in nature. The seat elevation, or standing feature, served the same purpose as other equipment that assisted people in reaching items or having an eye-level conversation with a standing person, CMS said.

But groups such as the American Academy of Physical Medicine & Rehabilitation (AAPM&R) challenged the idea that the elevation feature offered only a superficial advantage in arguing for Medicare coverage of the wheelchairs.

In a comment to CMS, AAPM&R noted that there was an equity issue at play, as well. More affluent people have been able to pay for seat-elevation features on their own, while many other people cannot afford them, wrote Prakash Jayabalan, the chair of AAPM&R health policy and legislation committee, urging CMS to finalize its proposal on coverage. Finalizing the CMS proposal, as the agency later did, would be a "major step forward for the disability population," Jayabalan wrote.

He added, "Allowing beneficiaries with a permanent disability to access technology to stand, reach, and function in their home and community, is not a luxury, nor is it an item of convenience, but a necessity."

Kerry Dooley Young is a freelance journalist in Washington, D.C. who has been covering Medicare since 2006.

CMS

medical devices

Medicare

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