The guidelines below include the following topics. Click on a topic to go directly to that section.
- General Coverage Criteria
- Initial Coverage for New Set-Up (First 3 Months)
- Continued Coverage Beyond the First 3 Months of Therapy
- Accessories
- References (Local Coverage Determination and Policy Article)
General Coverage Criteria
Covered if the beneficiary is diagnosed with obstructive sleep apnea (OSA). Coverage for this equipment is diagnosis driven. Please refer to the Policy Article in the References section below for associated ICD-10 diagnosis codes.
The PAP policy applies to both a Continuous Positive Airway Pressure (CPAP) device as well as a bi-level device when used to treat OSA. The diagnosis of OSA must be documented by either an attended, facility-based polysomnogram (sleep study) or an in-patient hospital-based or home-based sleep test (HST). The sleep study must be signed by the interpreting practitioner.
Initial Coverage for New Set-Up (First 3 Months)
Continuous Positive Airway Pressure (CPAP)
A single level continuous positive airway pressure (CPAP) 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 initial evaluation should document pertinent information about the beneficiary’s history of sleep-related issues and should address the following elements but may include other details. Each element would not have to be addressed in every evaluation.
History- Signs and symptoms of sleep disordered breathing including snoring, daytime sleepiness, observed apneas, choking or gasping during sleep, morning headaches
- Duration of symptoms
- Validated sleep hygiene inventory such as the Epworth Sleepiness Scale
- Focused cardiopulmonary and upper airway system evaluation
- Neck circumference
- Body mass index (BMI)
- The beneficiary has a sleep test that meets either of the following criteria (1 or 2):
- The Apnea-Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) ≥ 15 events per hour with a minimum of 30 events; or
- AHI or RDI ≥ 5 and ≤ 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 his/her caregiver has/have received instruction from the supplier of the PAP device and accessories in the proper use and care of the equipment.
Bi-Level Device
A bi-level device without backup rate is covered for those beneficiaries with OSA who meet criteria A – C above, in addition to criterion D:
D. A single level positive airway pressure device 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 PAP device 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). The treating practitioner must document that an appropriate interface has been properly fit and the beneficiary uses it without difficulty, the CPAP pressure setting prevented the beneficiary from tolerating the therapy and lower pressure settings of the CPAP tried but failed to:
1. Adequately control the symptoms of OSA, or
2. Improve sleep quality, or
3. Reduce the AHI/RDI to acceptable levels.
Continued Coverage Beyond the First 3 Months of Therapy
No sooner than the 31st day but no later than the 91st day after initiating therapy, the treating practitioner must conduct a face-to-face clinical re-evaluation and document that the beneficiary is benefiting from PAP therapy.
Documentation of clinical benefit is demonstrated by:
- Face-to-face clinical re-evaluation by the treating practitioner (between the 31st and 91st day) with documentation that symptoms of obstructive sleep apnea are improved, and the beneficiary is benefiting from PAP therapy; and
- Objective evidence of adherence to use of the PAP device. Adherence to therapy is defined as use of PAP at least 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. This can be accomplished either through direct download or visual inspection of adherence information.
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 a PAP device was used for more than 3 months and the beneficiary was then switched to a bi-level, the clinical re-evaluation must occur between the 31st and 91st day following the initiation of the bi-level. There would also need to be documentation of adherence to therapy during the 3 month trial with the bilevel.
Accessories
Accessories used with a PAP device are covered when the coverage criteria for the device are met. Quantities of supplies greater than those described in the policy as the usual maximum amounts will be denied as not reasonable and necessary.
Accessory | Usual Maximum Replacement | |
---|---|---|
A4604 | Tubing with integrated heating element | 1 per 3 months |
A7027 | Combination oral/nasal mask | 1 per 3 months |
A7028 | Oral cushion for combination oral/nasal mask | 2 per 1 month |
A7029 | Nasal pillows for combination oral/nasal mask | 2 per 1 month |
A7030 | Full face mask | 1 per 3 months |
A7031 | Replacement face mask interface for full face mask | 1 per 1 month |
A7032 | Replacement cushion for nasal mask interface | 2 per 1 month |
A7033 | Replacement pillows for nasal cannula type interface | 2 per 1 month |
A7034 | Nasal interface (mask or cannula type) | 1 per 3 months |
A7035 | Headgear | 1 per 6 months |
A7036 | Chinstrap | 1 per 6 months |
A7037 | Tubing | 1 per 3 months |
A7038 | Disposable filter | 2 per 1 month |
A7039 | Non-disposable filter | 1 per 6 months |
A7046 | Replacement water chamber for humidifier | 1 per 6 months |
References
- Local Coverage Determination - Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea
- A52467 - Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article