Practical applications of the new CMS national coverage determination guidelines for noninvasive ventilation in COPD

Hospitalizations due to COPD exacerbations carry a poor long-term prognosis. As noninvasive ventilation (NIV) improves admission-free survival for patients with chronic hypercapnia through high-intensity positive airway pressure, respiratory assist devices (RADs) and home mechanical ventilators (HMVs) remain a cornerstone of therapy.^1,2

On June 9, 2025, the Centers for Medicare and Medicaid Services (CMS) issued a finalized national coverage determination regarding NIV coverage for respiratory failure due to COPD.³ Since many durable medical equipment companies have already begun to apply these criteria, it is important for clinicians to become familiar with the changes.^3,4

Initial coverage for both RADs and HMVs now spans a 180-day period, with follow-up required twice in the first year. Baseline hypercapnia, defined as a Paco₂ ≥ 52 mm Hg on an arterial blood gas measurement on the patient’s prescribed Fio₂, must be demonstrated. Sleep apnea should also be ruled out, though formal testing is not required. Pulmonary function tests are also not required.

Qualification for a RAD with a backup rate (E0471) has now been simplified and can be prescribed as first-line therapy, no longer requiring overnight oximetry. In the preceding two weeks, patients must demonstrate stable COPD symptoms or persistent hypercapnia. By 180 days, CMS requires high-intensity therapy with these devices, defined as a minimum inspiratory positive airway pressure of ≥ 15 cm H₂O and a backup rate of ≥ 14 beats per minute. For patients unable to tolerate high-intensity therapy or who do not require a backup rate, a RAD without a backup rate (E0470) is covered. A RAD with or without a backup rate is covered on hospital discharge if a RAD or ventilator was needed within 24 hours of discharge to prevent exacerbation of symptoms or worsening hypercapnia. 

HMV coverage is now more clearly defined. If, in addition to hypercapnia, the patient requires oxygen at ≥ 4 liters per minute (36% Fio₂), ventilatory support for ≥ 8 hours per day, or alarms and internal battery—or if consistent usage of a RAD for ≥ 4 hours per day would not improve hypercapnia or symptoms—an HMV is covered. Similarly, if the patient’s needs exceed the capabilities of a RAD on hospital discharge, an HMV is covered. The new guidelines also cover an additional interface (mask or mouthpiece) if the patient is using a volume-targeted mode for ≥ 8 hours a day with an oronasal mask at night.

Usage requirements for RADs and HMVs are similar at follow-up: ≥ 4 hours per day for ≥ 70% of a 30-day period. For RADs, the patient should also demonstrate improvement, stabilization, or normalization in hypercapnia and/or symptoms by six months. It is important to remember that while a RAD is pay-to-own, HMV coverage remains a monthly rental, which can be costly for patients.

While local coverage determinations are still pending, these changes to NIV coverage should allow providers to more readily obtain RADs for their patients, which should improve readmission rates. However, it remains unclear how these changes will impact the care of chronic respiratory failure due to other lung diseases, hypoventilation, and diaphragmatic dysfunction. 

1. Murphy PB, Rehal S, Arbane G, et al. Effect of home noninvasive ventilation with oxygen therapy vs oxygen therapy alone on hospital readmission or death after an acute COPD exacerbation: a randomized clinical trial. JAMA. 2017;317(21):2177-2186. doi:10.1001/jama.2017.4451

2. Köhnlein T, Windisch W, Köhler D, et al. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014;2(9):698-705. doi:10.1016/S2213-2600(14)70153-5

3. Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD. Centers for Medicare & Medicaid Services. June 9, 2025.

4. Respiratory Assist Devices, Local Coverage Determination L33800. Centers for Medicare & Medicaid Services. October 1, 2015.