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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that the term PAP (positive airway pressure) device will refer to both a single-level continuous 
positive airway pressure device (E0601) and a bi-level respiratory assist device without back-up rate (E0470) 
when it is used in the treatment of obstructive sleep apnea. 
 
    An E0601 device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A  C are met: 
 
        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. 
 
        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. 
 
        The beneficiary and/or their caregiver has received instruction from the supplier of the device in the 
proper use and care of the equipment. 
 
If a claim for an E0601 is submitted and all of the criteria above have not been met, it will be denied as not 
reasonable and necessary. 
 
    An E0470 device is covered for those beneficiaries with OSA who meet criteria A-C above, in addition to 
criterion 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 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 beneficiary with OSA and criteria A-D are not met, it will be denied as not reasonable 
and necessary. 
 
A bi-level positive airway pressure device with back-up rate (E0471) is not reasonable and necessary if the 
primary diagnosis is OSA. If an E0471 is billed with a diagnosis of OSA, it will be denied as not 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 in-person clinical evaluation or a new sleep test. 
 
If an E0601 device has been used for more than 3 months and the beneficiary is switched to an E0470, a new 
initial in-person clinical evaluation is required, but a new sleep test is not required. A new 3 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 related 
Policy Article (PA). 
 
CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY: 
 
Continued coverage of a PAP device (E0470 or E0601) 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. 
 
For PAP devices with initial dates of service on or after November 1, 2008, documentation of clinical benefit is 
demonstrated by: 
 
1. In-person clinical re-evaluation by the treating practitioner with documentation that symptoms of obstructive 
sleep apnea are improved; and 
 
2. Objective evidence of adherence to use of the PAP device, reviewed by the treating practitioner. 
 
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. 
 
Beneficiaries who fail the initial 12 week trial are eligible to re-qualify for a PAP device but must have both: 
 
    In-person clinical re-evaluation by the treating practitioner 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. 
 
If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, 
substitution of an E0470 does not change the length of the trial unless there is less than 30 days remaining in 
the trial period. If more than 30 days remain in the trial period, the clinical re-evaluation would still occur 
between the 31st and 91st day following the initiation of an E0601 and objective documentation of adherence 
on the E0470 would need to occur prior to the 91st day following initiation of the E0601. If less than 30 days 
remain in the trial period, the clinical re-evaluation and objective documentation of adherence must occur 
before the 120th day following the initiation of the E0601. 
 
If an E0601 device was used for more than 3 months and the beneficiary was then switched to an E0470, the 
clinical re-evaluation must occur between the 31st and 91st day following the initiation of the E0470. There 
would also need to be documentation of adherence to therapy during the 3-month trial with the E0470. If there 
is discontinuation of usage of a PAP device at any time, the supplier is expected to ascertain this and stop 
billing for the equipment and related accessories and supplies. 
 
For a PAP device dispensed prior to November 1, 2008, if the initial Medicare coverage criteria in effect at the 
time were met and the criteria for coverage after the first 3 months that were in effect at the time were met, the 
device will continue to be covered for dates of service on or after November 1, 2008 as long as the beneficiary 
continues to use the device. Either a non-heated (E0561) or heated (E0562) humidifier is covered when ordered 
by the treating practitioner for use with a covered PAP (E0470 or E0601) device. 
 
You can find these rules in the Local Coverage Determination (LCD) Positive Airway Pressure (PAP) Devices 
for the Treatment of Obstructive Sleep Apnea L33718. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.