Updates to Clinical Coverage Policy 5A-2: Non-invasive Ventilator Policy

Clinical Coverage Policy 5A-2, Respiratory Equipment and Supplies, is updated to add policy guidelines for home ventilators with a non-invasive interface and to add HCPCS codes E0466 to the Durable Medical Equipment and Supplies (DME) fee schedule as a continuous rental. In addition to correcting numerical, grammatical and style errors, the following changes include:

Section 5.3.2 Respiratory Devices for the Treatment of Respiratory Disorders other than Obstructive Sleep Apnea (OSA), subsection Other Respiratory Devices, now reads:

1. Ventilators

• Medicaid and NCHC shall cover a home ventilator with an invasive interface for treatment of neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to chronic obstructive pulmonary disease. Coverage is provided for both positive and negative pressure ventilators.
• Medicaid and NCHC shall cover a home ventilator with a non-invasive interface when criteria “a.” through “c.” are met:

1. Clinical documentation indicates that:
   1. the beneficiary’s condition cannot be successfully managed on a BiLevel device with pressure support, or
   2. BiLevel therapy and BiLevel therapy with a backup feature has been initiated and failed to adequately correct the beneficiary’s respiratory status

2. Documentation indicates that ONE (1) of the following conditions is present:
   1. Restrictive lung disease when the beneficiary meets the following:
      
      1. Beneficiary has chronic respiratory failure with:
         
         1. Daytime CO2 retention greater than 50 mm Hg, or
         2. CO2 retention of 45 to 50 mm Hg with symptoms attributable to hypoventilation (such as morning headaches, restless sleep, nightmares, enuresis, or daytime hypersomnolence), and
         3. Nighttime oxygen desaturation to less than or equal to 88% for five (5) continuous minutes while breathing the beneficiary’s usual FiO2, and
         4. Obstructive sleep apnea has been ruled out

1. 2. Chronic obstructive pulmonary disease (COPD) when the beneficiary meets the following:
      
      1. beneficiary has chronic respiratory failure symptoms with symptoms attributable to hypoventilation, and
      2. Any of the following physiologic criteria:
         
         1. PaCO2 greater than or equal to 55mm Hg, or
         2. PaCO2 50-54mm Hg and nighttime oxygen desaturation less than or equal to 88% for five (5) continuous minutes while breathing the beneficiary’s usual FiO2, or
         3. PaCO2 50-54mm Hg and hospitalization related to recurrent (at least two (2) episodes in a 12-month period) hypercapnic respiratory fail
   3. Progressive neuromuscular disorder such as:
      
      1. ALS
      2. Muscular dystrophy
      3. Multiple Sclerosis
      4. Spinal muscle atrophy
      5. Myasthenia gravis
      6. Primary lateral sclerosis
          
   4. Chest wall deformity;
   5. Acute poliomyelitis;
   6. Spinal cord diseases/conditions; or
   7. Central hypoventilation syndrome or obesity hypoventilation

3. Beneficiary can protect airway and clear secretions adequately.

Prior approval is required for home ventilators. Recertification is at 12 months. A lifetime PA may be considered at recertification if medical necessity is demonstrated.

Section 5.3.1 Oxygen, Oxygen Supplies, and Equipment, all references to 30 calendar days and 90 calendar days are updated to one (1) month and three (3) months respectively.

Section 5.3.2 Respiratory Devices for the Treatment of Respiratory Disorders other than Obstructive Sleep Apnea (OSA), respiratory assist device (RAD) policy guidance, criterion b. now reads:

2. Severe chronic obstructive pulmonary disease (COPD):
3. The beneficiary must meet the following criteria:
   1. Documentation of the beneficiary’s severe COPD and an arterial blood gas study, done while awake and breathing the beneficiary’s usual FIO2, demonstrating a PaCO2 that is greater than or equal to 52 mmHg; and one of the following:
   2. Sleep oximetry demonstrating oxygen saturation less than or equal to 88% for at least five (5) minutes in total, done while breathing the beneficiary’s usual FIO2; or
   3. Prior to initiating therapy, OSA (treatment with CPAP) has been considered and ruled-out.
       
4. Prior Approval (PA) is required for a RAD.
5. Note: The above criteria qualify the beneficiary for a RAD without a back-up rate.

• For a beneficiary with COPD who qualifies for a RAD without a back-up rate, and the treating physician believes the beneficiary requires a RAD with a back-up rate, the device may be covered if the following criteria are met:
  
  1. The treating physician documents that a BiLevel device without back-up rate has been initiated and failed to adequately correct the beneficiary’s respiratory status; or
  2. An arterial blood gas PaCO2, repeated no sooner than 61 calendar days after initiation of compliant use of the RAD without a back-up rate, done while awake and breathing the beneficiary’s usual FIO2, remains greater than or equal to 52 mm Hg; and
  3. A signed and dated statement from the treating physician, completed no sooner than 61 calendar days after initiation of the RAD without a back-up rate, declaring that the beneficiary has been compliantly using the device an average of four (4) hours per 24-hour period, but that the beneficiary is NOT benefiting from its use.

Attachment A, Section C: Procedure Codes, the HCPCS code for home ventilators with a non-invasive interface (E0466) was added.

Additional Resources

Additional information is available at the North Carolina Medicaid Medical Equipment policies web page. Providers should refer to the DME fee schedule for the current E0466 rental rate.

DMA Clinical Policy and Programs
DMEPOS section, 919-855-4310