The Centers for Medicare & Medicaid Services (CMS) has published a proposed decision memo on Medicare coverage for noninvasive positive pressure ventilation (NIPPV) used in the home to treat chronic respiratory failure (CRF) resulting from chronic obstructive pulmonary disease (COPD).
CMS is accepting public comments until April 10, 2025.
In the memo, CMS proposes Medicare coverage for the following:
— Respiratory Assist Devices (RAD) with a backup rate feature. Would deliver high-intensity noninvasive ventilation (NIV) (IPAP>20 cm H2O and backup respiratory rate of at least 14 breaths per minute). Would be covered in the home for an initial 180-day period for COPD patients meeting certain criteria, including persistent hypercapnia (elevated levels of carbon dioxide in the blood) not caused by sleep apnea.
— RAD without backup rate feature. For COPD patients with chronic respiratory failure “who cannot tolerate high-intensity NIV or for whom the backup rate feature is otherwise medically inappropriate.” Would be covered in the home for an initial 180-day period when certain criteria are met, including persistent hypercapnia not caused by sleep apnea.
— RAD upon hospital discharge. For patients who required a RAD “within the 24-hour period prior to hospital discharge to avoid rapid symptom exacerbation or rise in PaCO2 [partial pressure of carbon dioxide in arterial blood].” Covered RAD could be with or without backup rate. Covered RAD “must be the same as that used during the last 24 hours of the in-patient admission.”
Qualifying for continued RAD coverage
In the proposed decision memo, CMS suggested that patients be re-evaluated no more than 180 days after receiving the RAD, and at least every six months going forward “to establish that continued coverage by Medicare beyond the first 180 days is medically necessary.
“Medicare will not continue coverage into the seventh and succeeding months of therapy until the required re-evaluation is performed and establishes that continued coverage is medically necessary.”
During re-evaluations, the practitioner must confirm the following to maintain RAD coverage for the patient:
— Consistent use of the RAD, on average, for at least five hours during a 24-hour period.
— Achievement of specified clinical outcomes that can be linked to RAD usage, such as normal or improved PaCO2 readings, a reduction in COPD episodes that require hospitalization, and an improvement in at least one symptom linked to chronic hypercapnia, including headaches, fatigue, confusion, or shortness of breath.
Coverage for home mechanical ventilators
CMS proposed home mechanical ventilator coverage “used in a volume targeted mode as treatment for an individual with chronic respiratory failure consequent to COPD who exhibits certain clinical characteristics.”
To qualify, patients must demonstrate “persistent hypercapnia” at specified levels and must require oxygen therapy, ventilatory support, and/or the alarms and internal battery of a home mechanical ventilator. Another qualifying factor could be that the consistent use of a RAD with backup rate feature wouldn’t be sufficient to achieve certain clinical outcomes.
CMS also proposed to cover an HMV upon hospital discharge for an initial 180-day period. For continued coverage, CMS proposed patient re-evaluation no later than 180 days after the patient received the HMV, and re-evaluations at least every six months going forward to confirm ongoing medical necessity.
For patients who use HMV for more than eight hours per 24-hour period and use an oronasal mask at night, CMS also proposed to cover “either mouthpiece ventilation or nasal mask for use during day hours.”
That mask coverage “does not exclude coverage of additional supplies used for HMV necessary for the effective use of the HMV,” CMS added.
Stakeholders can submit public comments via the CMS website until April 10.
