High-intensity positive pressure ventilation is the standard of care for patients with respiratory disorders, such as COPD or neuromuscular diseases, that provide adequate oxygenation but inadequate CO₂ clearance. Noninvasive ventilation (NIV) devices are widely used at home in the rest of the world, but the Centers for Medicare and Medicaid Services (CMS) rarely covers them in the US. CHEST is leading the battle to change CMS’ perspective.

“The reimbursement system tells us not to follow the science,” said Peter C. Gay, MD, MS, FCCP, professor of medicine at the Mayo Clinic. “CMS just doesn’t understand the issue. It’s a technical expertise problem and we can help.”

Dr. Gay discussed continuing efforts to align reimbursement for home NIV with the clinical evidence during the CHEST 2020 Margaret Pfrommer Endowed Memorial Lecture in Home-based Mechanical Ventilation “Navigating to Home NIV Nirvana: What Would Margaret Do?”. Registered attendees can view Dr. Gay’s discussion of home-based ventilation on demand through February 1, 2021.

The problem, he explained, is that reimbursement policy for NIV is driving clinical practice in the US when clinical evidence should be driving reimbursement policy.

Dr. Gay co-organized and cochaired the Optimal Noninvasive Medicare Access Proposal Technical Access Panel in late 2020 to help CMS better understand the clinical and cost-effectiveness benefits of home NIV.

Lack of reimbursement for home NIV has nothing to do with science and everything to do with cost, he said. As evidence supporting high-pressure ventilation in hypercapnic patients grew, more pulmonologists followed the evidence and prescribed home NIV.

Medicare costs for home NIV skyrocketed. CMS reported that spending for E0464 Pressure Support Ventilators (noninvasive) grew from $5 million in 2010 to $181 million in 2014. The agency responded by changing reimbursement criteria in 2015.

CMS announced it would rely on a 2001 National Coverage Analysis Decision stating that a RAD is “distinguished from ventilation in a patient for whom interruption or failure of respiratory support leads to death.” The use of ventilators in situations other than life support would be denied as not reasonable and necessary.

Noninvasive home ventilation began with the first CPAP devices in the early 1980s. Clinical research in the US, the United Kingdom, and elsewhere continued to support the development of CPAP, bilevel positive airway pressure devices, adaptive servo ventilator devices, and more.

A growing body of evidence showed that ventilation could do more than provide oxygenation. It could also normalize CO₂ levels, improving quality of life, improving survival, and reducing hospital readmission. The Food and Drug Administration continued to approve more effective NIV devices and CMS continued to avoid reimbursement.

“They were always one step ahead of us to be sure the reimbursement system curbed prescription use by physicians,” Dr. Gay said.

The biggest problem, he continued, was CMS’ inability to follow the clinical science underlying NIV. The agency approached inadequate ventilation as an oxygenation issue. Yet in COPD and other diseases of inadequate ventilation, the problem was not hypoxia but hypercapnia.

“We had to convince them that this is a respiratory problem, not an oxygenation problem,” he said. “There is strong evidence for high-intensity ventilation. Higher positive pressures deliver higher positive results for our patients. It must be practice that guides coverage criteria, not the reverse. We can change this sad picture.”