BIPAP ADULTS (Initial Trial)

I.  Bilevel positive airway pressure with or without backup rate feature in adults (>18 yrs old) for an initial trial period of up to 90 days may be considered medically necessary when ALL of the following criteria are met:

A.  a diagnostic sleep study with 4 channels (including oxygen saturation, respiratory movements, airflow and ECG or heart rate) has been performed in a health care facility OR a 3 or 4 channel study done in the home (including arterial oxygen saturation and airflow, or abdominal and chest wall movement) OR a type IV device (including pulse oximetry, actigraphy, and peripheral arterial tone) (e.g., Watch-PAT device) has been performed AND

B.  the formal sleep study report must be interpreted by a pulmonologist or sleep physician and documents ANY of the following:

1.  complex sleep apnea (CompSA)  OR

2.  central sleep apnea (CSA)  OR

3.  obstructive sleep apnea and the member has at least ONE of the following;

a.  failure of CPAP to meet therapeutic goals and reduce the AHI or RDI to acceptable levels during the titration portion of the facility-based study OR

b.  intolerance to CPAP despite proper mask selection, fitting and appropriate pressure settings  OR

c.  ineffectiveness of CPAP to adequately control the symptoms of OSA and improve sleep quality

4.  restrictive thoracic disorder such as severe thoracic cage abnormalities or neuromuscular disease (e.g. ALS) and ALL of the following criteria are met:

a.  symptoms of sleep-related Hypo-ventilation interfere with ADLs such as dyspnea, excessive sleepiness, morning headaches, excessive fatigue AND

b.  hypoxemia is characterized by ANY of the following:

i.  oxygen saturation is less than or equal to 88% for at least 5 continuous minutes during sleep oximetry (minimum recording time of two hours), done while breathing the member's usual FIO2 (fractional inspired oxygen concentration) OR

ii. arterial blood gas PaCO2 is greater than or equal to 45 mm Hg while awake and breathing the member's usual FIO2 OR

iii. for members with progressive neuromuscular disease such as ALS, the maximal inspiratory pressure (MIP) is less than 60 cm H2O OR the FVC (forced vital capacity) is less than 50% of predicted. 

c.  Chronic obstructive pulmonary disease (COPD) does not contribute significantly to the member's pulmonary disease

5.  severe COPD and ALL of the following criteria are met:

a.  symptoms of sleep-related Hypo-ventilation and hypoxemia interfere with ADLs such as, dyspnea, excessive daytime sleepiness, morning headache, excessive fatigue, AND

b.  OSA as the etiology for symptoms is ruled out  AND

c.  hypoxemia is characterized by ALL of the following:

i.  oxygen saturation is less than or equal to 88% for at least five continuous minutes during sleep oximetry (minimum recording time of two hours), done while breathing the member's usual FIO2 or two liters per minute, whichever if higher  AND

ii.  arterial blood gas PaCO2 is greater than or equal to 52 mm Hg. 

6.  Hypoventilation syndrome and ALL of the following criteria are met:

a.  FEV1/FVC on spirometry is greater than or equal to 70% AND

b.  hypoxemia  is characterized by ANY of the following:

i.  oxygen saturation is less than or equal to 88% for at least five continuous minutes during sleep oximetry (minimum recording time of two hours), done while breathing the member's usual FI02 OR

ii.  arterial blood gas PaC02 is greater than or equal to 45 mm Hg while awake and breathing the member's usual FI02  AND

C.  OSA as the etiology for symptoms is ruled out

II.  Services are not medically necessary if the above criteria are not met

BIPAP PEDIATRICS (Initial Trial)

I.  Bilevel positive airway pressure with a backup rate feature in children for an initial trial period of up to 150 days may be considered medically necessary when ALL of the following criteria are met:

A.  a diagnostic sleep study with 4 channels (including oxygen saturation, respiratory movements, airflow and ECG or heart rate) has been performed:

1.  in a health care facility OR

2.  in the home AND

B.  the formal sleep study report must be interpreted by a pulmonologist or sleep physician and documents ANY of the following:

1.  Complex sleep apnea (CompSA)

2.  Central sleep apnea (CSA)

3.  Obstructive sleep apnea and the member has at least ONE of the following:

a.  failure of CPAP to meet therapeutic goals and reduce the AHI or RDI to acceptable levels during the titration portion of the facility-based study OR

b.  intolerance to CPAP despite proper mask selection, fitting and appropriate pressure settings OR

c.  ineffectiveness of CPAP to adequately control the symptoms of OSA and improve sleep quality.

4.  restrictive thoracic disorders such as severe thoracic cage abnormalities or  neuromuscular disease (e.g Spinal muscular atrophy (SMA) or Duchenne muscular dystrophy (DMD)), and Hypo-ventilation is characterized by ANY of the following:

a.  oxygen saturation is less than or equal to 90% for at least 10% of the sleep study or recording time of the trend sleep oximetry (minimum recording time of 2 hours), done while breathing he member's usual FIO2 (fractional inspired oxygen concentration) OR

b.  arterial blood gas PaCO2 is greater than or equal to 45 mm Hg while awake and breathing the member's usual FIO2 OR

c.  > 25% of sleep time with either end tidal CO2 > 50 mm-Hg OR

d.  for members with progressive neuromuscular disease such as SMA or DMD, the FVC is less than 70% 

5.  Hypoventilation syndrome that is characterized by ANY of the following:

a.  oxygen saturation is less than or equal to 90% for at least 10% of the sleep study or recording time of the trend sleep oximetry (minimum recording time of 2 hours), done while breathing the member's usual FIO2 (fractional inspired oxygen concentrator) OR

b.  arterial blood gas PaCO2 is greater than or equal to 45 mm-Hg while awake and breathing the member's usual FIO2 OR

c.  >25% of sleep time with either end tidal CO2 or transcutaneous CO2 > 50 mm-Hg.  

II.  Services are not medically necessary if the above criteria are not met.

BIPAP ADULTS/PEDIATRICS (Continuation)

I. BIPAP continued use in adults (>18 yrs old) and children after the initial trial period may be considered medically necessary when ALL of the following criteria are met:

A.  AHI or RDI has improved from pretreatment value AND

B.  compliance is confirmed by objective evidence that the CPAP is used for at least four hours per night on 70% of nights during a consecutive thirty (30) day period

II.  Services are not medically necessary if the above criteria are not met.

BIPAP (Replacement)

X.  Replacement of BIPAP devices may be considered medically necessary when ANY of the following criteria are met:

A.  the device is at least 5 years old  OR

B.  the member has experienced a change in physiological condition and meets criteria for continued use of the device  OR

C.  the device is malfunctioning, the required repairs would exceed the cost of replacement, and the device has exceeded the warranty period  OR

D.  there is irreparable damage to the device due to normal wear and tear. 

NOTES

•  repairs of the BIPAP device do not require PA review
• after the initial 90 day trial period is completed, a second PA request must be submitted to establish medical necessity for continued use.
• once coverage for continued use of the PAP device is approved, the DME vendor may bill by either method:
• purchase price upfront minus the initial 90 days rental cost  OR
• continued rental cost up to the purchase price.
• if a member received a PAP device under their previous carrier and ongoing payment for the device is needed, a PA request must be submitted to establish medical necessity for continued use
• replacement due to abuse or misuse is not covered.
• completed, a second PA request must be submitted to establish medical necessity for continued use.

ORAL APPLIANCES

I.  Oral appliances (tongue-retaining devices or mandibular advancing/positioning devices) in adults (> 18 years old) diagnosed with OSA may be considered medically necessary when ALL of the following criteria are met:

A. A diagnostic sleep study with 4 channels (including oxygen saturation, respiratory movements, airflow and ECG or heart rate) has been performed in a health care facility OR a 3 or 4 channel study done in the home (including arterial oxygen saturation and airflow, or abdominal and chest wall movement) OR a type IV device (includes pulse oximetry, actigraphy, and peripheral arterial tone) (e.g. Watch-PAT device) AND

B.  the formal sleep study report must be interpreted by a pulmonologist or sleep physician and documents that diagnosis of OSA by ONE of the following:

1.  Apnea-Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) of at least 15 events/hour OR

2.  AHI or RDI of at least 5 events/hour and the member has at least ONE of the following symptoms:

a.  excessive daytime sleepiness OR

b.  impaired daytime cognitive function such as decreased concentration or memory loss OR

c.  new mood changes such as irritability  OR

d.  insomnia or chronic fragmented sleep  OR

e.  hypertension  OR

f.  ischemic heart disease  OR

g.  history of stroke  OR

h.  increased neck circumference of greater than 16 inches in women and 17 inches in men  AND

C.  a trial with CPAP has failed, is not tolerated, or is contraindicated AND

D.  the device is prescribed by the treating physician  AND

E.  the device is custom fitted by qualified dental professionals  AND

F.  there is absence of temporomandibular dysfunction and periodontal disease.

II.  Services are not medically necessary if the above criteria are not met.

III. An Oral appliance is considered investigational for any indication other than OSA.

IV. The treatment of snoring without accompanying clinically significant OSA is not a covered benefit.

V.  The following devices are considered investigational for the management of OSA:

A.  palate expansion devices

B.  nasal expiratory positive airway pressure devices

C.  oral pressure therapy devices.

ORAL APPLIANCE (Replacement)

I.  Replacement of an Oral appliance may be considered medically necessary when ALL of the following criteria are met:

A.  symptoms have improved or resolved  AND

B.  compliant use of the appliance is documented  AND

C.  the appliance is at least 5 years old OR the member has experienced a change in physiological condition and meets criteria for use of the appliance.

D.  there is irreparable damage to the device due to normal wear and tear. 

HOME VENTILATOR

Initial Trial

I.  Trial of non-invasive home ventilator (mask or chest shell) (E0466) may be considered medically necessary when the following criteria are met:

      A.  Individual has failed bilevel positive airway pressure (BiPAP), AND

      B.  Does not require ventilation continuously (24 hours/day), AND

      C.  Has ONE of the following diagnoses:

           1.  Restrictive Thoracic disorders

                a.  Neuromuscular disease (e.g., amyotrophic lateral sclerosis (ALS))

           2.  Chronic respiratory failure due to COPD

           3.  Central sleep apnea

           4.  Complex sleep apnea

           5.  Hypoventilation syndrome

II.  If criteria above are met, the first three (3) months of therapy will be approved. 

III. If criteria are not met, coverage will be denied as not medically necessary for the device and related accessories.

Continuation after initial 3 months

I.  Non-invasive home ventilator (mask or chest shell) (E0466) use after the initial trial may be considered medically necessary if ALL the following criteria are met: 

      A.  Follow up visit within the previous 3 months, AND

      B.  Documentation of relevant symptoms and clinical benefit from continued use, AND

      C.  Relevant test results (e.g., pulmonary function, pulse oximetry, PSG), AND

      D.  Current treatment plan

II.  Services are not medically necessary if the above criteria are not met. 

•       Approval for 12 months (e0466), after the initial trial if the above criteria are met.

Annual recertification

      A.  Annual recertification (12 months) for non-invasive home ventilator (mask or chest shell) (E0466) may be considered medically necessary when documentation is submitted including face-to-face visit within the previous 6 months with clinical notes of patient current status.  

NOTES

• repairs of the home ventilator do not require PA review 
• replacement due to abuse or misuse is not covered