Since the unprecedented Philips Respironics recall, many medical societies and patient advocacy organizations are working together to ensure uninterrupted patient treatment due to policy requirements.
Patient Treatment Disruption
Although Philips hasn’t provided a time estimate regarding replacements and repairs, there is a concern that the recall will disrupt many patients diagnosed with obstructive sleep apnea (OSA) and their prescribed course of treatment.
Many policy requirements can disrupt patient treatment, including:
- Time-specified adherence rules
- Sleep test requirements
- Clinical evaluation
- Device replacement rules
- Patient repair or replacement costs
CMS and Private Payers Support Needed
Undersigned medical societies and patient advocacy organizations have urged private insurance payers and CMS to support OSA patients during this recall.
Organizations include:
- American Academy of Sleep Medicine (AASM)
- American Academy of Neurology (AAN)
- American Thoracic Society (ATS)
- American, College of Chest Physicians (CHEST)
- Alliance of Sleep Apnea Partners (ASAP)
- American Sleep Apnea Association (ASAA)
How CMS and Private Payers Can Help
CMS and private payers can help support OSA patients and DME suppliers and providers by:
- Temporarily suspending any time-specified adherence rules.
- Allowing patients to receive a new device or have their current one repaired.
- Allowing exceptions to coverage requirements for replacing PAP equipment after a certain number of years.
Repairs and Replacements
Help provide patient support by allowing DME suppliers to repair or replace recalled devices without requiring:
- Documentation of a new clinical evaluation
- Sleep test or trial period
- Remove patient costs for any repair or replacement expenses
90-day Adherence Rule & Equipment Replacement Requirement
All the Phillips Respironics recall devices are subject to the CMS Local Coverage Determination (LCD) Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718). The L33718 requirement states that a clinical re-evaluation and documentation is needed “no sooner than the 31st day but no later than the 91st day after starting therapy”.
L33718 also includes specific requirements regarding equipment replacement. It states, “If a PAP device is replaced during the 5-year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident, there is no requirement for a new clinical evaluation, sleep test, or trial period.”
The aforementioned medical societies and patient advocacy organizations are asking CMS to temporarily suspend this 90-day adherence rule. While also allowing an exception to the RUL requirements for the Philips Respironics recalled products.
FDA Recommendations
The U.S. Food and Drug Administration (FDA) has released recommendations for health care providers and patients during this recall. Read the entire FDA Safety Communication article. Some recommendations include:
- Review the FDA recommendations with the patient and encourage them to talk with their health care provider. Actions may include:
- Using another similar device (that’s not part of the recall)
- Using alternative treatments for sleep apnea
- Beginning long term therapies for sleep apnea
- Follow the manufacturer’s instructions and recommended cleaning and replacement guidelines
- Register the device on Philips Respironics’s recall website
- Report device problems through the FDA’s MedWatch Voluntary Reporting Form
Information about the Philips Respironics Recall
The Philips Respironics recall notification impacts 18 Bi-Level PAP, CPAP, and mechanical ventilator devices that are part of the first-generation DreamStation product line. Access the complete list of the recalled devices here.
The Philips voluntary recall is due to the potential health risks of the polyester-based polyurethane (PE-PUR) sound abatement foam, which may degrade over time and enter the patient’s airway, or the foam may off-gas certain chemicals.
Read Philips Respironics Recall – What DME Providers Can Expect for more information regarding this recall.
Stay Up to Date with Medbill
The Medbill team will provide you with valuable information and guidance on how to handle this recall. If you have any questions, contact the Medbill team.
Learn more about how Medbill’s DME billing services can help you.