WASHINGTON, DC – Last week, CMS distributed an alert on Philips respiratory products under recall. In their notice, CMS tells patients with recalled devices:
“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 5 years old [emphasis ours]. If the equipment is more than 5 years old, Medicare will help pay for a replacement.”
CMS’ notice is causing disruption for respiratory suppliers who are hearing from patients that are taking this notice as an indication that replacement products or repair procedures are readily available. This development is not surprising, given the lack of any context in the alert on the current constraints on availability of replacement equipment or any acknowledgement that the FDA has not yet approved a repair procedure for affected devices.
“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 & 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.”
AAHomecare will provide information on replacement product availability, repair protocols, and updates from CMS, FDA, and Philips as details become available.