A. Patient has direct clinical evaluation by physician prior to sleep test for assessment of OSA.
B. Patient has sleep test (as defined below) that meets criteria a or b.
a. AHI (apnea-hypopnea index) or RDI (respiratory disturbance index) is greater or equal to 15 events per hour with a minimum of 30 events or
b. The AHI or RDI is greater 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 patient and/or caregiver have received instruction from supplier of CPAP, of proper use and care of equipment.
If a claim for a CPAP is submitted and ALL of above criteria has not been met, it will be denied as not reasonable and necessary.
Bilevel respiratory assist devices without back-up rate are covered for patients with OSA who meet criteria above as well as criteria below.
D. CPAP has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or home setting.
Ineffective is defined as documented failure to meet therapeutic goals using a 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).
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 physician must conduct a clinical re-evaluation and document that the beneficiary is benefiting from PAP therapy.
Face-to-face clinical re-evaluation by the treating physician with documentation that symptoms of obstructive sleep apnea are improved; and
Objective evidence of adherence to use of the PAP device, reviewed by the treating physician.
Adherence to therapy is defined as use of PAP ≥ 4 hours per night on 70% of nights during a consecutive 30 day period anytime during the first three months of initial usage. If above criteria are not met, continued coverage of a PAP device and related accessories will be denied as not reasonable and necessary.
If the physician re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the patient 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 the re-evaluation.
Beneficiaries who fail the initial 12 week trial are eligible to requalify for a PAP device but must have both:
Face-to-face clinical re-evaluation by the treating physician to determine the etiology of the failure to respond to PAP therapy; and,
Repeat sleep test in a facility-based setting (Type 1 study). This may be a repeat diagnostic, titration or split-night study.
