CPAP AND BIPAP MACHINES
DEFINITIONS:
Apnea is defined as the cessation of airflow for at least 10 seconds.
Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% decrease in oxygen saturation.
The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hypopnea per hour of sleep without the use of a positive airway pressure device. For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the AHI. Sleep time can only be measured in a Type I (facility based polysomnogram) or Type II sleep study (see descriptions below).
The respiratory disturbance index (RDI) is defined as the average number of apneas plus hypopneas per hour of recording without the use of a positive airway pressure device. For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the RDI. The RDI is reported in Type III, Type IV, and Other home sleep studies.
If the AHI or RDI is calculated based on less than 2 hours of sleep or recording time, the total number of recorded events used to calculate the AHI or RDI (respectively) must be at least the number of events that would have been required in a 2 hour period (i.e., must reach ≥30 events without symptoms or ≥10 events with symptoms).
INITIAL COVERAGE:
In this policy, the term PAP (positive airway pressure) device will refer to both a single-level continuous positive airway pressure device and a bi-level respiratory assist device without back-up rate when it is used in the treatment of obstructive sleep apnea.
I. A CPAP device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A – C are met:
A. The beneficiary has an in-person clinical evaluation by the treating practitioner prior to the sleep test to assess the beneficiary for obstructive sleep apnea.
B. The beneficiary has a sleep test (as defined below) that meets either of the following criteria (1 or 2):
The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events; or,
The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of:
Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
Hypertension, ischemic heart disease, or history of stroke.
C. The beneficiary and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment.
A BIPAP device is covered for those beneficiaries with OSA who meet criteria A-C above, in addition to criterion D:
D. An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.
Ineffective is defined as documented failure to meet therapeutic goals using an CPAP 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 BIPAP is billed for a beneficiary with OSA and criteria A-D are not met, it will be denied as not reasonable and necessary.
CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:
Continued coverage of a PAP device beyond the first three months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating practitioner must conduct a clinical re-evaluation and document that the beneficiary is benefiting from PAP therapy.
Adherence to therapy is defined as use of PAP ≥4 hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months of initial usage.
If the above criteria are not met, continued coverage of a PAP device and related accessories will be denied as not reasonable and necessary.
If the treating practitioner re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the beneficiary is benefiting from PAP therapy as defined in criteria 1 and 2 above, continued coverage of the PAP device will commence with the date of that re-evaluation.