CPAP - BIPAP

 
Note:  The following coverage criteria is for Medicare, other insurances may have different criteria and may be less stringent.  In most cases, meeting Medicare criteria will meet all other criteria’s.

• A written signed and dated prescription prior to dispensing is required before a CPAP is covered by Medicare.
• The face to face notes must include the conditions for coverage  as described below (these must be completed and signed prior to dispensing the item):

In this policy, 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.
 
A CPAP (E0601) device is covered initially for the treatment of obstructive sleep apnea (OSA) if criteria 1 - 3 are met:

1. The patient has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the patient for obstructive sleep apnea.
2. The patient has sleep test that meets either of the following criteria (a or b):
   1. 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,
   2. 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:
      1. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
      2. Hypertension, ischemic heart disease, or history of stroke.
3. The patient 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.

A BiPAP or Bi-Level (E0470) device is covered for those patients with OSA who meet criteria 1-3 above, in addition to the following:
 

1. A CPAP (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 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).

• If a BiPAP/Bi-level (E0470) is billed for a patient with OSA and above criteria 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 face-to-face clinical evaluation or a new sleep test.
• If an E0601 device has been used for more than 3 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 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 Policy Article (PA).

Concurrent use of oxygen with PAP therapy:
If a patient requires simultaneous use of home oxygen therapy and a PAP device, documentation by the treating practitioner in the medical record must clearly demonstrate that the requirements for coverage outlined in both the PAP and Oxygen policy have been met.
 
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 physician must conduct a clinical reevaluation and document that the beneficiary is benefiting from PAP therapy.

1. Face-to-face clinical re-evaluation by the treating physician 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 physician. 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 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 that re-evaluation.
• Beneficiaries who fail the initial 3 month trial are eligible to re-qualify 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.

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.

1. 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.
2. 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.
3. If a CPAP (E0601) device was used for more than 3 months and the patient was then switched to an E0470, the clinical reevaluation must occur between the 31st and 91st day following the initiation of the E0470.
   1. There would also need to be documentation of adherence to therapy during the 3 month trial with the E0470.

REPLACEMENT:

1. This section applies to PAP devices initially provided and covered while the beneficiary was in Medicare fee-for-service (FFS).
2. If a PAP device is replaced during the 5 year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident, there is no requirement for a new clinical evaluation, sleep test, or trial period. If a PAP device is replaced following the 5 year RUL, there must be a face-to-face evaluation by their treating physician that documents that the beneficiary continues to use and benefit from the PAP device. There is no requirement for a new sleep test or trial period.

BENEFICIARIES ENTERING MEDICARE
For beneficiaries who received a PAP device prior to enrollment in fee for service (FFS) Medicare and are seeking Medicare coverage of either rental of the device, a replacement PAP device and/or accessories, both of the following coverage requirements must be met:

1. Sleep test – There must be documentation that the beneficiary had a sleep test, prior to FFS Medicare enrollment, that meets the Medicare AHI/RDI coverage criteria in effect at the time that the beneficiary seeks Medicare coverage of a replacement PAP device and/or accessories; and,
2. Clinical Evaluation – Following enrollment in FFS Medicare, the beneficiary must have a face-to-face evaluation by their treating physician who documents in the beneficiary's medical record that:
   1. The beneficiary has a diagnosis of obstructive sleep apnea; and,
   2. The beneficiary continues to use the PAP device.

If either criteria 1 or 2 above are not met, the claim will be denied as not reasonable and necessary.
In these situations, there is no requirement for a clinical re-evaluation or for objective documentation of adherence to use of the device.
ACCESSORIES:
Accessories used with a PAP device are covered when the coverage criteria for the device are met. If the coverage criteria are not met, the accessories will be denied as not reasonable and necessary.
The following table represents the usual maximum amount of accessories expected to be reasonable and necessary:
A4604 - 1 per 3 months
A7027 - 1 per 3 months
A7028 - 2 per 1 month
A7029 - 2 per 1 month
A7030 - 1 per 3 months
A7031 - 1 per 1 month
A7032 - 2 per 1 month
A7033 - 2 per 1 month
A7034 - 1 per 3 months
A7035 - 1 per 6 months
A7036 - 1 per 6 months
A7037 - 1 per 3 months
A7038 - 2 per 1 month
A7039 - 1 per 6 months
A7046                                 -                                  1                                 per                                    6                                months
Quantities of supplies greater than those described in the policy as the usual maximum amounts will be denied as not reasonable and necessary.
A supplier must not dispense more than a 3-month quantity of PAP accessories at a time.
Either a non-heated (E0561) or heated (E0562) humidifier is covered when ordered by the treating physician for use with a covered PAP (E0470 or E0601) device.