Clarification of Non-FDA Approved CPAP Devices During PHE

Published in 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.


1 Unless used as “Ventilator, Continuous, Minimal Ventilatory Support”; see complete product listings here.


TAGS

  1. phe
  2. regulatory

From Our Experts

Proposed Rule Suggests Significant Change To Accreditation Process thumbnail Proposed Rule Suggests Significant Change To Accreditation Process The recently released proposed rule CMS-1828-P contains a significant change that could reshape how suppliers navigate accreditation. The rule proposes a major change that would require suppliers to be surveyed and reaccredited annually instead of the current three (3) year cadence. This proposal raises substantial questions about both operational feasibility and cost implications. August Of Action: Your Chance To Connect With Congress thumbnail August Of Action: Your Chance To Connect With Congress It's time to take advantage of August Of Action—a perfect opportunity to make your voice heard. Every summer, federal legislators return to their home states during the Congressional recess. While it gives them a break from Washington D.C., it's primarily a time for them to connect with constituents like you. HR1 Passes House, Advances to President Trump's Desk for Signature thumbnail HR1 Passes House, Advances to President Trump's Desk for Signature After extensive negotiations and partisan debate, the House has officially passed HR1, clearing the path for the bill to be signed into law by President Donald Trump. The legislation, which aims to reduce federal healthcare expenditures, contains several provisions that may impact the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) industry. CMS files the Proposed Rule that sheds light on the next round of the Competitive Bidding Program thumbnail CMS files the Proposed Rule that sheds light on the next round of the Competitive Bidding Program On June 30, 2025, CMS filed the anticipated Proposed Rule that includes updates to the Competitive Bidding Program (CBP). Public comments are due 60 days from June 30, 2025. Below is a high-level summary of the rule. It is critical to note that, according to the Proposed Rule Fact Sheet dated June 30, 2025, CMS has stated that they have not announced the specific product categories they are bidding or the specific timeframe for the next competition. Those specifics will be forthcoming in a fu Senate Narrowly Passes HR1, Sending It Back to House for Final Approval thumbnail Senate Narrowly Passes HR1, Sending It Back to House for Final Approval President Donald Trump's sweeping legislative package, formally titled the One Big, Beautiful Bill Act, now referred to as HR1., cleared the Senate today in a dramatic 51–50 vote, with Vice President JD Vance casting the tie-breaking vote. The bill now returns to the House, where lawmakers must decide whether to adopt the Senate's revised version or negotiate further changes before it can reach the president's desk. Several Prominent Medicaid Provisions in Senate's Budget Bill Deemed in Violation of Byrd Rule thumbnail Several Prominent Medicaid Provisions in Senate's Budget Bill Deemed in Violation of Byrd Rule Senate Parliamentarian Elizabeth MacDonough advised this week that multiple Medicaid provisions in the Senate's reconciliation bill would violate Senate procedure by violating the Byrd Rule. The Byrd Rule is a Senate-specific procedural process that allows Senators to prevent or block inclusion of extraneous provisions in reconciliation bills. Other provisions are still under review. Evaluating the Value of a Payer Contract thumbnail Evaluating the Value of a Payer Contract In our last article, Key Payers Denied Your Application Citing Their Network Is Closed – Now What?, we discussed strategies for addressing payer contracting denials due to a closed network. As indicated, this process can be an extremely time-consuming exercise with no guarantees and mixed results. Below are a few things to consider as you evaluate whether a contract is worth the extra effort. Webinar: Webinar: "Navigating The New CMS Landscape: RADs, HMVs, and Supplier Survival" on June 25 at 1 p.m. CT. The Centers for Medicare & Medicaid Services (CMS) has released its final National Coverage Determination (NCD) for RADs and HMVs used in treating chronic respiratory failure due to COPD. While the rule potentially expands access to bilevel ST therapy (RADs), it also introduces complex compliance requirements, tighter usage criteria, and increased documentation burdens—without additional reimbursement.