Tag: Philips Recall

AMSTERDAM – Philips could hear back from the U.S. Food and Drug Administration in August about its plans to replace the foam in certain CPAP devices and ventilators, based on a timeline provided during the company’s July 26 conference call to discuss financial results for the second quarter.  Philips filed 806 applications for corrections and removals with the FDA in June and CEO Frans van Houten said, based on prior experience, there’s typically an eight-week turnaround.  “I...

WASHINGTON – VGM has asked the U.S. Food and Drug Administration to expedite its approval process for a replacement foam for respiratory devices affected by the Philips recall.  “We are requesting accelerated approval from the FDA for this critical replacement component for approved technicians to rapidly start the process of replacing/repairing all recalled units,” states VGM in a letter to the agency.  Philips on June 14 announced a voluntary recall of certain...

WASHINGTON – VGM has asked the U.S. Food and Drug Administration to expedite its approval process for a replacement foam for respiratory devices affected by the Philips recall.  “We are requesting accelerated approval from the FDA for this critical replacement component for approved technicians to rapidly start the process of replacing/repairing all recalled units,” states VGM in a letter to the agency.  Philips on June 14 announced a voluntary recall of certain...

YARMOUTH, Maine – CGS has updated its FAQ on the Philips recall, adding two new questions and revising three questions. The two new questions are: If a beneficiary with a patient-owned recalled device refuses warranty support or chooses to purchase a replacement device out of pocket, will the DME MACs honor an executed ABN that holds the beneficiary responsible for replacement (outside of warranty) as same or similar to equipment previously purchased be Medicare? The DME MACs will...

YARMOUTH, Maine – Three weeks after Philips issued a voluntary recall for certain mechanical ventilators, including its popular Trilogy 100 and 200, providers say they're still waiting for guidance on how to move forward.   “Right now, we’re in wait-and-see mode,” said Chris Burgess, vice president of clinical services for Med Emporium in Charlotte, N.C. “We haven’t been given guidance. We’ll roll out a corrective action, as soon as we get...

WASHINGTON – Noridian Healthcare Solutions has posted FAQs for Jurisdictions A and D on the impact of the Philips recall on coverage and billing for Medicare beneficiaries, AAHomecare has reported.  Among the questions in the FAQ:  How should DME suppliers address the situation with Medicare beneficiaries who are in the first 90-days adherence metric in the PAP and RAD Local Coverage Determinations (LCDs)?  Response: During the Public Health Emergency...

WASHINGTON – The Food and Drug Administration has issued a Safety Communication regarding the Philips recall of certain respiratory devices.  According to a bulletin from AAHomecare, the communication summarizes major issues and considerations related to the recall, and encourages patients using BiPAP and CPAP machines to discuss treatment options and alternatives with their healthcare providers, including “Continuing to use your affected device, if your health care provider...

WASHINGTON - AAHomecare has reached out to the DME MAC medical directors to address the challenges HME providers and patients face due to the Philips recall.  In a letter to the four directors, the association requests that the DME MACs continue to reimburse for equipment and supplies affected by the recall for patients who continue to use them, as well as implement a temporary suspension of time-specific adherence rules to allow patients time to have devices repaired or replaced.    “AAHomecare...

We’ve been doing a lot of talking here at HME News about the Philips recall. In fact, I’m pretty sure that’s all anyone’s been talking about in the industry, on webinars, on state association calls, to me. Forget COVID. "This is going to be far worse,” is a common refrain. It’s not hard to understand why, even as we don’t yet fully know how far the ripple effect will spread. While the immediate concerns have focused on just getting information to communicating...

WASHINGTON – Noridian Healthcare Solutions has posted FAQs for Jurisdictions A and D on the impact of the Philips recall on coverage and billing for Medicare beneficiaries, AAHomecare has reported.  Among the questions in the FAQ:  How should DME suppliers address the situation with Medicare beneficiaries who are in the first 90-days adherence metric in the PAP and RAD Local Coverage Determinations (LCDs)?  Response: During the Public Health...