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Notice of Recall: Philips Issues a Recall Notification* to Mitigate Potential Health Risks Related to the Sound Abatement Foam Component in Certain Sleep and Respiratory Care Devices
Posted On: June 14, 2021 by Philips: Philips News Center| Global
On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.
At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available. As a result of extensive ongoing review following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (International Markets) for specific affected devices.
The recall notification (U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken. Additionally, the notification provides details of our robust and comprehensive repair and replacement program, to correct this issue as efficiently and thoroughly as possible.
The recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions:
For patients using life-sustaining mechanical ventilator devices:
- Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
- If your physician determines that you must continue using this device, use an inline bacterial filter. Consult your Instructions for Use for guidance on installation.
For patients using BiLevel PAP and CPAP devices:
- Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment.
We cannot stress enough that Philips is treating this matter with the highest possible seriousness, and are dedicating significant time and resources to address this issue.
This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction.
We are absolutely committed to supporting the worldwide community of patients who rely on our Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs.
CMS Releases New Fee Schedule With Increased Oxygen Rates Effective April 1, 2021
Effective for claims with dates of service on or after April 1, 2021, the fee schedule amounts for HCPCS codes E0424, E0431, E0433, E0434, E0439, E0441, E0442, E0443, E0444, E0447, E1390, E1391, E1392, E1405, E1406, and K0738 are adjusted to remove a percentage reduction that was put in place to meet the budget neutrality requirement previously mandated by section 1834(a)(9)(D)(ii) of the Social Security Act. These new rates are not retroactive; they will only be effective for dates of service on or after April 1, 2021. These adjustments result in an increase in Medicare fee schedule amounts ranging from:
- $6.72 to $8.19 in former competitive bidding areas
- $5.17 to $5.43 in other non-rural areas
- $4.41 to $6.82 in noncontiguous and rural area
Providers can access the new CMS fee schedule(s) for rural, non-rural, and Competitive Bid Areas (CBAs) here: www.cms.gov/medicaremedicare-fee-service-paymentdmeposfeescheddmepos-fee-schedule/dme21-b
The Oxygen Budget Neutrality issue dates back to 2017, when CMS incorrectly applied a budget neutral “offset” to fee schedules for oxygen concentrators. This led to an improper reduction in reimbursement for several oxygen-related HCPCS codes, and forced reimbursement rates in some areas below the average regional competitive bidding Single Payment Amounts (SPA). The Consolidated Appropriations Act of 2021 (Public Law 116-260), which was signed into law on December 27, 2020, corrected this action for DME suppliers. Section 121 of this Act eliminates the budget neutrality requirement set forth in section 1834(a)(9)(D)(ii) of the Social Security Act for separate classes and national limited monthly payment rates established for any item of oxygen and oxygen equipment.
You can read the full release from CMS here: www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched