Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD

Respiratory failure consequent to chronic obstructive pulmonary disease (COPD) is a condition that may be treated with both pharmacologic and non-pharmacologic methods. Noninvasive positive pressure ventilation (NIPPV) in the home is one method of non-pharmacologic treatment and includes home mechanical ventilators (HMVs), bi-level positive airway pressure (BPAP) devices and continuous positive airway pressure (CPAP) devices.

The Durable Medical Equipment (DME) Reference List found in National Coverage Determination (NCD) 280.1, lists both positive and negative pressure ventilators for the treatment of chronic respiratory failure (CRF) consequent to COPD as an equipment category that is coverable under the DME benefit.

CMS received a request for reconsideration of NCD 280.1, to establish coverage policies for the use of noninvasive home mechanical ventilators and respiratory assist devices for Medicare beneficiaries with various respiratory conditions. CMS accepted the request for the indication of chronic obstructive pulmonary disease and will develop a new NCD section.

The scope of this NCA is limited to NIPPV in the home for the treatment of CRF consequent to COPD and will focus on clinical indications for the initial and continued use of BPAP and HMV as well as the characteristics of these devices. This NCA will analyze the clinical evidence pertinent to this topic for outcomes of interest that may include improvement of physiologic signs along with decreased mortality, decreased frequency of exacerbations requiring emergency room or hospital admission, increased time to hospital re-admission for respiratory related disease, and improved function and quality of life.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of BPAP or HMVs in the home management of chronic respiratory failure in patients with COPD. We are also interested in aspects of health disparities and health equity that should be considered in the review.

September 11, 2024