As the sleep community becomes more aware of the incidence of complex sleep apnea, HME providers are seeing more requests to distribute the E0471 “respiratory assist device with back up rate.” While that can be good news for those who are trying to enhance their respiratory product offering, it is not good news if the medical records are not adequately detailed. The same is true for a diagnosis of central sleep apnea.
When considering only patients who are new to therapy (not upgrading from CPAP), there are some very specific requirements that must be met in order for you to get paid and keep your money.
It all starts with the diagnosis. There are a limited number of diagnoses that, per the LCD, demonstrate the need for an E0471. Every one of them must also be validated by diagnostic testing results that are mandated. The addition of the KX modifier on the claim indicates the supplier has validated that all the required metrics have been met and are contained within the medical record.
Note that obstructive sleep apnea (OSA) is not one of them. Think of the E0471 as a device that actually helps someone breathe when, due to disease, they are not able to do so well enough on their own. This is opposed to CPAP, which is utilized to keep the airway splinted open, not actually assist with the mechanics of breathing.
There are only four disease types that are articulated within the LCD as impairing a person's breathing, thus warranting the dispensing of an E0471:
- Restrictive Thoracic Disorder
Imagine a person who simply cannot take a deep breath due to disease or deformity. Severe kyphoscolisos or other chest wall deformities fit here. This category at times will function as a catch-all, as it will often include patients who have neuromuscular/neurological diseases such as ALS, MS or muscular dystrophy.
- COPD
These patients usually can get the air in fine, but due to degeneration of the lung, cannot get the air out. This causes a buildup of carbon dioxide, thus the need for assistance in getting rid of the old air. Think of the old adage “In with the good air, out with the bad.” Measurement of “PCO2” (the pressure of the carbon dioxide gas in the blood, which, if high, indicates poor breathing) is one of the required diagnostic tests.
- Central Sleep Apnea or Complex Sleep Apnea
Simplistically stated, central apneas are not a lung or airway problem. Instead, think of the brain just not sending the signal to the lung to breathe. In this case, the patient needs assistance in breathing.
Complex sleep apnea is most common in male patients who also may have congestive heart failure and what is known as Cheyne-Stokes respirations. Again, this is generally more neurological in nature, not pulmonary. According to the DME MAC LCDs, the definition of central apnea as a diagnosis states the total number of apneas seen during the sleep studies must be minimally 50 percent central in nature and not obstructive. You must look at the raw data contained within the sleep study and do the math.
- Hypoventilation (or Hypoventilation Syndrome)
For many, this category causes the most confusion, as all of the others generally lead to this. If people do not breathe or ventilate well, they of course “hypoventilate.” (The prefix “hypo” means “low” or “under.”) One diagnosis that perhaps might not be included under the other categories is a condition called “Pickwickian syndrome,” which is a combination of obesity, somnolence (sleepiness), hypoventilation and plethoric (red) face.
The hypoventilation category also probably causes the most challenges for providers in securing medical necessity. Not only must results of arterial blood gas (ABG) studies be on file but also spirometery — plus, either repeat the ABGs while the patient is asleep (which means a needle in the artery during sleep) or a sleep study that shows the patient demonstrated a low oxygen level (<88 percent for >5 minutes) that was not caused by upper airway events.
Problem areas to be cognizant of include the following:
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The diagnosis you get from the referral source does not meet the requirements of the LCD.
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The diagnosis given is acceptable; however the notes in the sleep study do not match that diagnosis. As an example, notes in the patient's chart (including the sleep study) never mention COPD, but instead note obstructive sleep apnea or mixed apnea.
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The diagnosis is valid, but none of the other required testing is on file or given to the provider. This would include ABGs or, as required for patients with neuromuscular disease, measurements of forced vital capacity (how deep they can breathe) or measurement of maximum inspiratory pressure (which indicates how strong the respiratory muscles are).
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Tests are provided, but not within the required parameters. This includes the patient who is normally on oxygen 24/7 or at night, yet the testing was done without any oxygen.
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The diagnosis given is central apnea, but the number of central apneas reflected in the sleep study is not at the required >50 percent of the total apneas seen.
If you want to provide RAD devices, find the most detail-oriented person on your team, start the validation process with the diagnosis and then make certain that all other required tests are both available and fall within the limits for coverage.
Kelly J. Riley, CRT, RCP is a longtime HomeCare contributor and recognized expert on respiratory practice.
