Legal Update: Monitor recall guidance

Q. What should I do in the wake of the Philips recall? 

A. On June 14, 2021, Phillips Respironics announced a voluntary recall for certain devices used to treat obstructive sleep apnea (OSA), including continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) devices and mechanical ventilators. This has resulted in patients being required to wait a number of months, if not longer, for their Respironics devices to either be replaced or repaired. Because of this wait period, DME suppliers, physicians, patients, CMS, the FDA, and commercial insurers are concerned about the possible implications that the recall will have.  

The primary concern is that the voluntary recall will disrupt treatment for patients with OSA, which, as a result, my cause patients to be unable to meet the adherence requirements set within payer coverage policies before their device can be fixed or replaced. Unfortunately, due to the sheer number of products affected by the recall (it is estimated that 3 million to 4 million products have been affected globally), significant delays in equipment repairs and replacements should be expected. As a result, private payers have repeatedly been urged to temporarily suspend all time adherence rules and, therefore, providing patients with an extended period of time to either have their devices replaced or repaired.  

While the effects of this recall are being felt by many, the FDA has recently provided guidance containing useful information for patients, DME suppliers, physicians and commercial insurers alike that have been affected by the recall and are unsure about how to proceed. While this guidance may not provide answers to all questions that are likely to arise, it is a starting point, and a great reference until further guidance can be released. We encourage all suppliers to closely monitor developments with respect to this recall. 

Kelly T. Custer is a shareholder with the Health Care Group at Brown & Fortunato. Reach him at (806) 345-6343 or at [email protected].