Stakeholders: Recall alert is misleading

WASHINGTON – Industry stakeholders are pushing back on a CMS alert that, they say, makes it seem like patients can get CPAP devices and ventilators affected by a recent Philips recall replaced or repaired right away. 

The alert states: “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.” 

Stakeholders point out that Philips is still waiting for approval from the U.S. Food and Drug Administration for replacement material and major disruptions in the supply chain are making CPAP devices and vents hard to come by. 

“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 Government Relations stated in a blog reacting to the alert. “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.” 

Stakeholders say the alert is causing further disruption for providers who are hearing from patients that are taking the alert as an indication that replacements or repairs are readily available. 

“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,” said Tom Ryan, AAHomecare president and CEO. “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.” 

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