CMS has released a final National Coverage Determination (NCD) that expands and clarifies coverage for certain respiratory devices used in the treatment of chronic respiratory failure due to chronic obstructive pulmonary disease (COPD).
Meet the Expert: Kelsey Kansler
Kelsey Kansler has been a key part of the Medbill team since 2011. As VP of Revenue Cycle Management and Automation, she brings deep insight into the evolving DME regulatory landscape—insight shaped by her roles on the PAMS Board and the Medicare Jurisdiction C Council.
What’s Covered Now—and What’s Changing
Medicare already covers Respiratory Assist Devices (RADs) for COPD-related chronic respiratory failure. But now, the NCD provides defined coverage criteria for Home Mechanical Ventilators (HMVs) for these patients for the first time.
RADs vs. HMVs: What’s the Difference?
While both devices help patients breathe, they differ in complexity and use:
- RADs (like BiPAPs) deliver higher pressure during inhalation than exhalation, with or without a backup breathing rate. They’re used in stable COPD cases with persistent high CO₂ (PaCO₂ ≥ 52 mmHg).
- HMVs are more advanced, offering volume-targeted ventilation modes, alarms, and internal battery power. They’re reserved for more severe cases, like patients requiring more than eight hours of support daily, high oxygen needs, or backup systems to prevent life-threatening interruptions.
Covered: Respiratory Assist Devices (RADs)
RADs are covered for an initial six-month period when the patient:
- Has chronic respiratory failure due to COPD with a PaCO₂ ≥ 52 mmHg
- Does not have sleep apnea as the predominant cause of hypercapnia
- Meets clinical criteria (e.g., stable COPD or post-hospitalization)
- Uses the device at least four hours per day on 70% of days
RADs are covered in two types:
- With a backup rate feature for high-intensity noninvasive ventilation
- Without a backup rate feature for those who can’t tolerate or can’t use the backup rate due to another condition
RADs are also covered immediately post-discharge if the patient used a RAD or ventilator within the 24 hours prior to discharge.
Covered: Home Mechanical Ventilators (HMVs)
HMVs are now explicitly covered for COPD patients who:
- Meet the same PaCO₂ and sleep apnea criteria as RAD patients
- Have more complex needs (e.g., require >8 hours/day of ventilation, higher oxygen needs, or alarms)
- Cannot be adequately supported by a RAD, even with high-intensity settings
HMVs are covered:
- For an initial six-month period
- Immediately after hospital discharge, if the patient’s needs exceed RAD capabilities
What This Means for DME Providers
This final NCD offers long-awaited clarity, but with it comes new layers of compliance and coordination.
To keep patients covered (and claims reimbursed), DME providers must:
- Track device usage (≥4 hours/day on ≥70% of days).
- Coordinate two clinical evaluations in the first year (around month 6 and again between months 7–12).
- Document measurable clinical outcomes (especially for RADs).
- Ensure ongoing compliance for rental and resupply eligibility.
Kelsey Kansler, VP of Revenue Cycle Management and Automation at Medbill, weighed in on the new standards, saying, “The multiple evaluations will add some complexity. Providers will need tighter coordination with clinicians and better internal systems to stay on top of it.”
With the new HMV criteria, DME teams should also revisit:
- Documentation and intake processes
- How they determine RAD vs. HMV candidacy
- Communication with referral sources
With clearer distinctions between RAD and HMV coverage, DME suppliers have a chance to reassess how they manage intake, documentation, and communication workflows.
“This is an opportunity for DME suppliers to streamline their processes and prevent coverage issues from the start,” Kansler says.
For more insights on navigating these changes and staying ahead of compliance requirements, visit the Medbill blog.