Equipment Usage and Compliance in the Respiratory Industry: What’s Right and How to Spot What’s Wrong

The respiratory industry is highly regulated, and rightfully so. Any industry that holds people’s health and safety in their metaphorical hands has no room for error in compliance.

Unfortunately, there are organizations that deliberately disobey equipment usage and compliance standards in order to cut corners and increase profits.

To help people better identify where organizations are not in compliance or are breaking usage standards, we have outlined some of the common regulations and how individuals can help hold companies breaking these regulations accountable.

Non-Invasive Ventilation Therapy Device Compliance

The best way to show compliance or non-compliance with these devices are by the hours used. The hours of use are usually captured when a respiratory therapist visits the patient at their home to conduct a “vent check”. Some non-invasive ventilators are so sophisticated that the hours of use by the patient are recorded and wirelessly transmitted to the DME provider. So it should be crystal clear to the DME provider whether or not this very expensive piece of rental equipment is being used by the patient and should be billed to the insurance company. There could be a significant liability for any DME company that routinely and knowingly bills for equipment not being used by the patient.

Sleep therapy device (CPAP and BiPAP) compliance

For various sleep issues, patients will be prescribed a CPAP or BiPAP to provide relief. There are a number of usage standards and compliance regulations that have to be followed to get insurance companies to continue paying for the devices. While there are a few differences for specific insurance companies, Medicare and most insurance companies require the following:

  • A set minimum usage throughout the first 90 days
  • Use of the device at least four hours a night for 70% of nights
  • A follow-up appointment with a doctor between the 31st and 90th day of treatment

Additionally, there are several instances of documentation that are necessary for insurance payment as well. They include:

  • A baseline sleep study that documents a condition necessitating a sleep device
  • Patient statistics such as BMI, airway system evaluation, and more
  • A write-up that proves the symptoms have improved with CPAP or BiPAP treatment

A type of fraud exists where companies forge the necessary documentation in order to recuperate insurance payments without legitimate cause. If you suspect this is happening in your organization, pay careful attention to the documentation and supporting documents submitted to the insurance companies. If they don’t line up with the treatments and evaluations that are actually taking place, it is a cause for concern.

How to report companies who are not in compliance with equipment usage regulations

If your organization is not complying with equipment usage regulations, you have the ability to set it right. You can expose fraud safely and securely with the right team of experts by your side. If you are unsure of where to start, the team at the Daniel J Ocasio Whistleblower Law Group will support you every step of the way.

Being a whistleblower in the respiratory industry is a noble act. You’ll help ensure organizations are doing the right thing and keeping innocent people safe for long after your report.


What Fraud Has Taken Place in the Respiratory Industry?

While no industry is immune to fraudulent practices, there are some industries that see more fraud than others — including the respiratory industry.

Respiratory is a focus industry for our law group because we firmly believe that an industry that handles people’s safety and well-being, as well as large sums of money, should be acting in good faith at all times.

But unfortunately, that hasn’t always been the case, as there have been multiple instances of fraud that vary in type and degree.

Types of fraud that have taken place in the respiratory industry:

The types of fraud that take place in the respiratory industry vary greatly by kind and degree. While this isn’t an exhaustive list, some common forms of fraud include:

  • Knowingly and routinely billing for rental equipment for non-compliant patients.
  • Billing insurance companies for products or services that never occurred
  • Forging or changing medical orders
  • Unnecessarily providing treatments
  • High-pressure sales tactics
  • Data mining
  • Avoiding lawful return of equipment
  • Multiple billing for home sleep testing

These fraudulent activities can end up costing billions of dollars per year, as the Department of Justice breaks down:

Each instance of respiratory fraud can look a little different from scenario to scenario, so it’s important to look at examples to understand the context and nuances of how they can play out in the real world.

Examples of fraud that has taken place in the respiratory industry

While there are too many examples of fraud that we’ve investigated to list them all, there are a few examples that highlight the severity of the situation and what the outcomes can look like.

Here are some well-known cases of respiratory fraud:

  • In the case involving medical equipment maker ResMed, $37.5 million was recovered by the government with $6.2 million being rewarded to the whistleblowers. In this case, ResMed filed false claims related to the sales of their equipment for sleep apnea and other sleep-related disorders.
  • In the Phillips Respironics case, $34.8 million was recovered by the government with $5.48 million being rewarded to the whistleblower. Respironics was providing free services to the providers who purchased their products. They would still be able to get these services if they did not purchase these products but would have to pay a monthly fee. This was in violation of the anti-kickback statute and the False Claims Act.
  • In the case involving Linde’s Lincare, $22.8 million was recovered by the government with $3.78 million dollars going to the whistleblowers involved. In this case, Linde’s Lincare fraudulently billed the government for oxygen and respiratory care equipment.

These investigations not only yielded significant rewards, but they also helped ensure the respiratory industry upholds its integrity and doesn’t cause more harm to innocent patients.

What to do if you witness fraud in the respiratory industry?

If you believe you’ve witnessed fraud in the respiratory industry, you should speak up now. If you are unsure of where to start, the team at the Daniel J Ocasio Whistleblower Law Group will support you every step of the way.