CMS releases final NCD for non-invasive ventilation 

WASHINGTON – CMS has released a final national coverage determination (NCD) for non-invasive positive pressure ventilation (NIPPV) in the home for the treatment of chronic respiratory failure consequent to COPD. 

The final NCD: 

• Provides coverage of respiratory assist devices (RADs) for the treatment of chronic respiratory failure that often accompanies COPD; and 
• For the first time, establishes coverage for home mechanical ventilation for patients with COPD. 

For all patient indications not included in the NCD, CMS says the Medicare Administrative Contractors (MACs) have authority to decide coverage. 

Industry stakeholders expressed concerns with a proposed NCD. 

Details in the NCD include:   

Nationally covered indications for RADs 

 A RAD with backup rate feature is covered in the home for an initial 6-month period for patients with COPD when all the following criteria are met: 

• The patient exhibits hypercapnia as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2; and 
• Sleep apnea is not the predominant cause of hypercapnia (Formal sleep testing is not required if, per the treating clinician, the patient does not experience sleep apnea as the predominant cause of hypercapnia.); and 
• The patient demonstrates one of the following characteristics: 
• Stable COPD, without increase in or new onset of more than one respiratory symptom (cough, sputum production, sputum purulence, wheezing, or dyspnea) lasting two or more days and no change of pharmacological treatment during the two-week period before initiation of NIV, or 
• Hypercapnia present for at least two weeks post hospitalization after resolution of an exacerbation of COPD requiring acute NIV. 

By the end of the initial six-month period, a RAD with backup rate feature must be utilized as high intensity therapy, defined as a minimum IPAP ≥15 cm H2O and backup respiratory rate of at least 14 breaths per minute. 

RAD without backup rate feature 

CMS will cover in the home a RAD without backup rate feature for a patient with CRF consequent to COPD who cannot tolerate high intensity NIV or for whom the backup rate feature is otherwise medically inappropriate.  A RAD without backup rate feature is covered in the home for an initial 6-month period for patients with COPD when all of the following criteria are met: 

• The patient exhibits hypercapnia as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2; and 
• Sleep apnea is not the predominant cause of the hypercapnia (Formal sleep testing is not required if, per the treating clinician, the patient does not experience sleep apnea as the predominant cause of the hypercapnia). 

RAD upon hospital discharge 

CMS will cover in the home a RAD with or without backup rate feature immediately upon hospital discharge for an initial 6-month period for patients with acute on chronic respiratory failure due to COPD, if the patient required either a RAD or ventilator within the 24-hour period prior to hospital discharge and the treating clinician determines that the patient is at risk of rapid symptom exacerbation or rise in PaCO2 after discharge. 

Continuing usage criteria for a RAD 

Patients must be evaluated at least twice within the first year after initially receiving a RAD. Evaluations must occur by the end of the six-month initial coverage period and again during months 7-12. 

First evaluation: 
By six months after receiving initial coverage of a RAD, the treating clinician must establish that usage criteria and clinical outcomes are being met. Specifically, the patient must be determined by a clinician to use the RAD at least 4 hours per 24-hour period, on at least 70% of days in a 30-day period and achieve at least one the following clinical outcomes: 

• Normalization (< 46 mmHg) of PaCO2, or 
• Stabilization of a rising PaCO2, or 
• 20% reduction in PaCO2 from baseline value, or 
• Improvement of at least one of the following patient symptoms associated with chronic hypercapnia: 
  • headache 
  • fatigue 
  • shortness of breath 
  • confusion 
  • sleep quality 

Second evaluation: 
Between 7-12 months after initially receiving a RAD, the treating clinician must establish the patient is using the device at least 4 hours per 24-hour period on at least 70% of days in each paid rental month. 

Post second evaluation: 
The patient must be using the device at least four hours per 24-hour period on at least 70% of days in each remaining paid rental month and any month in which accessories/supplies are dispensed. 

Nationally covered indications for HMV 

CMS will cover an HMV used in a volume targeted mode as treatment for a patient with CRF consequent to COPD who exhibits certain clinical characteristics. 

An HMV is covered for an initial 6-month period for patients with COPD when all of the following criteria are met: 

• The patient exhibits hypercapnia as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2; and 
• Sleep apnea is not the predominant cause of the hypercapnia (Formal sleep testing is not required if, per the treating clinician, the patient does not experience sleep apnea as the predominant cause of the hypercapnia.); and 
• The patient demonstrates at least one of the following characteristics: 
  • Requires oxygen therapy at an FiO2 ≥36% or ≥4L nasally, or 
  • Requires ventilatory support for more than 8 hours per 24-hour period, or 
  • Requires the alarms and internal battery of an HMV, because the patient is unable to effectively breathe on their own for more than a few hours and the unrecognized interruption of ventilatory support is likely to cause a life-threatening condition if the patient or caregiver cannot be otherwise alerted as determined by the treating clinician, or 
  • Per the treating clinician, none of the below are likely to be achieved with consistent use of a RAD with backup rate feature for at least 4 hours per 24-hour period on at least 70% of days because the patient’s needs exceed the capabilities of a RAD as justified by the patient’s medical condition: 
    • Normalization (< 46 mmHg) of PaCO2, or 
    • Stabilization of a rising PaCO2, or 
    • 20% reduction in PaCO2 from baseline value, or 
    • Improvement of at least one of the following patient symptoms associated with chronic hypercapnia: 
      • headache 
      • fatigue 
      • shortness of breath 
      • confusion 
      • sleep quality 

HMV use upon hospital discharge 

CMS will cover in the home an HMV used in a volume targeted mode immediately upon hospital discharge for an initial 6-month period for patients with acute on chronic respiratory failure due to COPD, if the patient’s needs exceeded the capabilities of a RAD (with or without backup rate feature) and required usage of a ventilator within the 24-hour period prior to hospital discharge and the treating clinician determines that the patient is at risk of rapid symptom exacerbation or rise in PaCO2 after discharge. 

Continuing usage criteria for an HMV 

Patients must be evaluated at least twice within the first year after initially receiving an HMV. Evaluations must occur by the end of the six-month initial coverage period and again during months 7-12. 

First evaluation: 
By 6 months after receiving initial coverage of an HMV, the treating clinician must establish that usage criteria are being met. The patient must be determined by a clinician to use the HMV at least 4 hours per 24-hour period, on at least 70% of days in a 30-day period. 

Second evaluation: 
Between 7-12 months after initially receiving an HMV, the treating clinician must establish the patient is using the device at least 4 hours per 24-hour period on at least 70% of days in each paid rental month. 

Post second evaluation: 
The patient must be using the device at least 4 hours per 24-hour period on 70% of days in each paid rental month. 

Masks for HMVs 

For patients who use an HMV in a volume targeted mode: 1) for greater than 8 hours in any 24-hour period; and 2) use an oronasal mask at night, a different interface (e.g., mouthpiece ventilation or nasal mask) is covered for daytime hours. Note, coverage of such supplies does not exclude coverage of additional supplies necessary for the effective use of the HMV.