Clarification of Non-FDA Approved CPAP Devices During PHE

Published in VGM Government Relations on November 05, 2021

VGM recently received this question:

Is it possible to bill a Class II Medical Device (CPAP) to insurance without a 510(k) clearance?  In the context of the pandemic, supply chain shortages, and the Philips Respironics recall, we are looking at alternative vendors for our CPAP product line. The device in question has an emergency FDA authorization but has not received a 501(k) clearance at this time. The vendor has no realistic idea of the potential risk we may incur, and we are looking for guidance regarding this time-sensitive situation.

To begin, let’s define a 510(k) clearance:

Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers who must register, to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.

Readers may be aware that during a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.

Before the FDA can issue a EUA, the Secretary of Health and Human Services must make a declaration of emergency or threat justifying authorization of emergency use for a product.

How do I know if the FDA has issued a EUA for a medical device? 

The FDA has a website that includes medical device EUAs. Go to Emergency Use Authorizations for Medical Devices. This page lists current EUAs issued for medical devices during the COVID-19 pandemic as well as EUAs issued during previous public health emergencies.

The FDA has released its Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.

The Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use of (among others) “personal respiratory protective devices” (March 2, 2020), and other medical devices, including alternative products used as medical devices (March 24, 2020), for use during the COVID-19 outbreak pursuant to section 564 of the Act and subject to the terms of any authorization issued under that section.

Do “personal respiratory protective devices” and/or “other medical devices” include CPAP?

The EUA link noted above includes categories:

• Respiratory Assist Devices EUAs
• Ventilators and Ventilator Accessories EUAs
• Other Medical Device EUAs

The first category (Respiratory Assist Devices) includes these EUAs; note there is no allowance for CPAP (nor Bi-level¹) devices   

The second (Ventilators and Ventilator Accessories) includes these EUAs.  This EUA authorizes the emergency use of “certain ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories” that the FDA determines meet specified criteria for safety, performance, and labeling. The devices that are eligible for inclusion under the EUA are those that are not currently marketed in the U.S., or those that are currently marketed in the U.S. but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket notification (510(k)) to the FDA, as discussed in the agency's Ventilator Enforcement Policy.

This page includes a list of authorized ventilator, ventilator tubing connector, and ventilator accessory to the list of authorized products in this Umbrella EUA during the COVID-19 public health emergency.

This same page includes:

• The EUA Letter of Authorization
• Facts Sheets for Healthcare Providers
• Facts Sheets for Patients
• Appendix A: Criteria for Safety, Performance, and Labeling
• Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories

The third category “Other Medical Devices” includes no inclusion of CPAP or bi-level devices.

Accordingly, there exists no exception for non-FDA-approved CPAP devices. They may not be billed to Medicare, Medicaid, or commercial insurance carriers. There are allowances for certain non-invasive ventilators and accessories. 

In summary, the process of the 510(k) is demonstrating to the FDA that the medical device is safe and effective for use and meets the medical device status. The CMS Quality Standards for DMEPOS, which are encompassed in accreditation requirements, requires suppliers of these services to make sure the medical equipment is safe and effective for beneficiary use.

Please review closely the information provided by the U.S. Food and Drug Administration via the links included within this update.

Questions?  Please contact Mark Higley, Vice-President of Regulatory Affairs, at mark.higley@vgm.com or 319.504.9515 or Ronda Buhrmester, Sr Director of Payer Relations & Reimbursement at ronda.buhrmester@vgm.com or 217-493-5440.

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1. phe
2. regulatory