CMS Pub. 100-04, ch. 32, § 416

Treatment of Chronic Respiratory Failure (CRF) Consequent to Chronic Obstructive

Pulmonary Disease (COPD)

(Rev. 13808; Issued:05-29-26; Effective: 06-09-25; Implementation: 10-22-25)

Respiratory Assist Devices (RADs) with bi-level capability, with or without a backup rate feature, are

devices that use a non-invasive interface (mask) to deliver a higher level of airway pressure when the

patient inhales than when the patient exhales. A backup rate feature enables the device to provide a

prespecified respiratory rate if the patient’s spontaneous respiratory rate decreases below a set number.

A home mechanical ventilator (HMV) delivers a predetermined amount of air with each breath and

typically has more monitoring, safety, alarm and backup power features (batteries) than a RAD.

416.1 Coverage

(Rev. 13808; Issued:05-29-26; Effective: 06-09-25; Implementation: 10-22-25)

Effective for services performed on or after June 9, 2025, the Centers for Medicare & Medicaid Services

(CMS) has determined that the evidence is sufficient to cover RADs, with or without a backup rate feature

and HMVs, in the home, to deliver noninvasive ventilation (NIV) as treatment for patients with chronic

respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD) as long as certain

patient criteria is met.

Note: This CR does not contain coding and billing instructions for masks.

Please refer to the National Coverage Determinations Manual (Publication, 100-03, Section 240.9 for

coverage criteria, frequency, and more information.