CMS’s Philips Recall Update Poses Problems

An alert from the agency tells Medicare patients to contact suppliers, but AAHomecare and VGM Government Relations both point out that the announcement’s phrasing will cause difficulties for sleep providers.

On Wednesday, CMS distributed an alert to Medicare beneficiaries regarding the Philips recall of sleep devices and ventilators that is proving problematic for suppliers of those devices, according to industry advocates.

In its alert, CMS advises: “If you would like to replace or repair your equipment, the supplier you bought the equipment from is responsible for replacing or repairing rental equipment at no cost to you when the equipment is less than five years old. If the equipment is more than five years old, Medicare will help pay for a replacement.”

CMS then provides directions and links on how beneficiaries can register their equipment with Philips.

According to both the American Association for Homecare and VGM Government Relations, the statement is already creating problems for HME providers supplying sleep equipment to Medicare beneficiaries, because it neither acknowledges the timeline and the recall process nor the fact that the FDA hasn’t yet approved a repair procedure for affected devices. It also fails to recognize the supply chain problems the recall and COVID-19 have created.

“While the statement released by CMS is accurate in that most of the patients impacted by the recall should expect to have their existing device repaired or replaced, it fails to mention that the process and timeline associated with repairing or replacing those devices could take several months,” VGM noted in a public statement. “We believe that should be clarified by CMS, as the current wording of the message they released will no doubt create unrealistic expectations for Medicare beneficiaries.”

AAHomecare noted in a statement that patients are already coming to providers under the misapprehension that replacements and repairs are readily available due to CMS’s advisory.

“We’re disappointed that CMS has chosen to raise the expectations of Medicare beneficiaries that a quick solution is at hand without providing any context on the constraints on product availability or approved repair protocols,” AAHomecare President and CEO Tom Ryan said. “Respiratory suppliers understand that they will be on the front lines in addressing this problem for millions of Americans who depend on these products.

“We urge CMS and the FDA to collaborate with all major stakeholders in this undertaking to ensure an effective and workable approach to repair or replace this critically needed equipment,” Ryan added.

VGM Government Relations is preparing a letter to CMS requesting that the agency issue a revised statement with additional clarification.

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