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By Eric Mongeau, National Sales Director at Aeroflow Healthcare
In June 2021, Philips issued a recall notification for specific Philips CPAP and mechanical ventilator devices due to potential health risks related to the sound abatement foam component. It was found that Philips CPAPs were degrading and releasing toxic gasses into the machine’s airways that users could inhale or swallow. The recall affected an estimated three to four million devices globally, based on the company’s production and shipment data – leaving many consumers turning to their healthcare providers for a solution.
Yet, while this was almost a year ago, many providers are still struggling to supply devices and find a solution for their patients. This is especially troublesome since more than six million people are diagnosed with sleep apnea each year, and only 25% of those people can currently access the CPAPs needed for their health. On top of the recall from Philips, the industry is also still being plagued by impacts from the pandemic. The other major CPAP supplier, Resmed, is currently undergoing an extremely constrained supply chain that is forcing healthcare providers to operate at about 25% of the inventory levels seen pre-recall.
How is the recall and supply chain shortage impacting the industry?
With supplies running extremely low, the devices providers are getting access to do not operate at the same level as devices pre-recall. They require patients to manually download a SD card to prove they are using them “70%” of the time. The idea that a patient must prove that they are wearing a device at least 70% of the time in order for their insurance provider to pay it is archaic. It also indicates that a patient working towards healthier outcomes and achieves 65% compliance is the equivalent to a patient who never wears the device. The device is common but is not intuitive for new users. Subjecting them to a new device, additional burdens, and threatening non-payment for failure to use a somewhat arbitrary amount of time seems to fail to put the patient first. Rather than focusing on the compliance of patients, providers should prioritize educating their customers on the types of benefits needed to help them achieve their health goals.
Another large setback that has surfaced since this recall is the lack of prioritization from manufacturers and access to the semiconductor chips needed to create new CPAP devices. Priority for chip manufacturers has been placed on other industries, such as transportation and consumer electronics, as demand continues to skyrocket. And the 510(k) clearances that are mandatory for medical suppliers to acquire chips is a very time-consuming process, which ultimately slows down the supply chain.
What’s more, provider reimbursement is currently stagnant. Many cannot push the increased cost to members, yet still need to find ways to fulfill orders. Medical device teams are now having to pay premium prices to have supply planes chartered to get the necessary equipment to the United States. These price increases can be traced back to the FDA and Center for Medicaid/Medicare Services (CMS) being disconnected on the issue, with the CMS setting a rate of reimbursement that is not attainable for providers at this time. These prices make it difficult for providers to enact solutions to help alleviate the constraints set by the recall.
Where can providers make a difference?
As this issue continues to disrupt the medical device industry, now is the time for providers to act and educate payers and lawmakers about the shortage. Especially with the pandemic continuing to shine a spotlight on the HME industry. To start making a difference, providers can:
- Negotiate with payers for increased reimbursement to aid the provider community who is currently experiencing increased costs due to device surcharges, labor and shipping cost increases, along with educating payers on why costs are at their current price.
- Write a letter to an automotive and technology company requesting that they reallocate a small portion of chips to PAP manufacturers.
- Write a letter to local congressman requesting they coordinate with the Department of Commerce to help with parity for chips in the healthcare sector, specifically addressing this issue.
- Work with payers to temporarily suspend the compliance period for PAP devices until after Philips has satisfied the FDA recall and ensure customers understand the new compliance protocols.
It’s important to remember that a little action can go a long way and if all these actions aren’t feasible for providers, simply encouraging your employees to participate and spread the word can be beneficial as well. There have already been positive outcomes from some providers’ outreach and the more that begin to participate in educating and spreading awareness on the current CPAP issues, the faster we can mend the industry. During these times, the medical device industry must be an advocate for itself, and providers must do their due diligence to ensure their patients are receiving the care and tools that are necessary for their health needs.