The E0470 (Respiratory Assist Device, bi-level pressure capability, without backup rate feature) can be covered by Medicare for patients with a diagnosis of obstructive sleep apnea (OSA). Medicare will allow for the E0470 if the patient meets the medical necessity requirements proving why the E0470 is required, as opposed to an E0601 (continuous positive airway pressure, or CPAP device).
RemitDATA has provided HomeCare with information stating that the overall denial rate for the E0470 is 14.4 percent. The majority of those E0470 claims were denied by Medicare with a 50 denial code: “These are non-covered services because this is not deemed a ‘medical necessity’ by the payer.” One reason for those medical necessity denials outside of the Respiratory Assist Device (RAD) Local Coverage Determination (LCD) is that providers did not meet the coverage criteria assigned by Medicare under the positive airway pressure (PAP) LCD.
A recent report by NHIC, the Jurisdiction A DME MAC, regarding CERT errors provided insight as to why some of the E0470 claims under the PAP policy could have been denied. The supporting documentation regarding the physician’s face-to-face re-evaluation prior to switching from CPAP to BIPAP was lacking documentation that supports the ineffectiveness of the CPAP. In addition, the treating physician’s clinical re-evaluation did not meet the date requirements of the LCD of being no sooner than the 31st day, but no later than the 91st day after initiating therapy. Providers did not submit documentation that the symptoms of obstructive sleep apnea were improved, and there was no objective evidence of adherence to use of the BIPAP device which was reviewed by the treating physician.
Another reason that the E0470 claims under the OSA diagnosis may deny with the 50 denial is that Medicare no longer down codes to the least costly alternative, the E0601. Remember that in order for the E0470 to be covered, the patient must meet all criteria associated with the coverage of the E0601 according to policy. An E0601 must have been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.
“Ineffective” is defined as a documented failure to meet therapeutic goals using an E0601 during the titration portion of a facility-based study or during home use despite optimal therapy (i.e., proper mask selection and fitting and appropriate pressure settings). If E0470 is billed for a patient with OSA and the criteria of the E0601 are not met, it will be denied as not being reasonable and necessary.
If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, substitution of an E0470 does not require a new initial face-to-face clinical evaluation or a new sleep test.
If an E0601 device has been used for more than three months and the patient is switched to an E0470, a new initial face-to-face clinical evaluation is required, but a new sleep test is not required. A new three-month trial would begin for use of the E0470. Coverage, coding and documentation requirements for the use of E0470 and E0471 for diagnoses other than OSA are addressed in the Respiratory Assist Devices (RAD) Local Coverage Determination (LCD) and Policy Article (PA).
With this in mind, providers will need to send E0470 denials coded as a 50 to Redetermination to prove that the patient meets the medical necessity requirements. Know your coverage requirements to prove the validity of your claim. If a denial comes your way, have the appropriate documentation available and compliant with the LCD to prove the medical need of your patient. Do not leave anything to chance—review the health record information with a fine-toothed comb. The best defense is a good offense!
