On June 9, the Centers for Medicare & Medicaid Services (CMS) released the final national coverage determination (NCD) for noninvasive ventilation (NIV) in patients with chronic respiratory failure due to chronic obstructive pulmonary disease (COPD). Now a uniform national policy outlines the qualification and management criteria for both respiratory assist devices (RADs) and home mechanical ventilators (HMVs). For home medical equipment (HME) providers, this marks a shift from equipment delivery to compliance-driven care coordination. How providers respond will determine whether they thrive or fall behind.
At Encore Healthcare, we’ve anticipated this evolution in respiratory care, designing around outcomes, not just orders. With the final NCD in place, the need for structured and scalable patient management has never
been clearer.
A Shift to National Uniformity
This NCD supersedes all prior local coverage determinations (LCDs); until now there has not been a NCD for NIV. For decades, Medicare beneficiaries in different regions or Medicare Advantage plans were subject to different qualifications for RADs and HMVs. That patchwork has now been replaced with national standards, creating a level playing field and a new set of rules.
The Good, the Bad & the Ugly
The HME industry asked for clear direction on NIV for years, and now we have it. This means:
- It is easier to qualify a patient for a RAD, removing the oxygenation requirement that has been a struggle for many years.
- There is a clear path to go directly to HMV without patients first needing to fail on a RAD device.
- The qualifications for HMV are strict but clinically sound.
- Arterial blood gas is the only accepted form of carbon dioxide (CO2) value for qualification.
- Ongoing compliance is required for months billed after the initial six months. No compliance means
no billing. - HME providers must be ready to track therapy timelines, collect and report clinical data and communicate efficiently with referring physicians.
A New Era of Accountability
CMS expects evidence-based patient management.
HME providers must:
- Coordinate closely with physicians
- Track and report compliance initially and ongoing for any month billed
- Provide timely reevaluations
- Support patients in meeting usage and pressure goals
This level of care requires more effort and the right tools and systems to manage that effort at scale.
Reevaluation Highlights
One of the biggest shifts is the re-evaluation requirement for continued coverage. Let's break it down by category of device.
For RADs With Backup Rate:
Within six months:
- Must have four hours per 24-hour period on at least 70% of days in a 30-day period.
- The treating clinician (provider) must establish usage criteria and clinical outcomes are being met (this is not required to be a face-to-face meeting).
- They must achieve high intensity ventilation, defined as an inspiratory positive airway pressure (IPAP) of ≥15 centimeters of water (cm H2O) and a backup rate ≥14 breaths per minute. If unable to achieve that IPAP or backup rate, then they should move to a RAD without backup rate.
- They should have stabilized CO2 or improved hypercapnia symptoms.
In seven to 12 months, the physician must establish that the patient is using the device at least four hours per 24-hour period on at least 70% of days in each paid rental month.
After the second evaluation, the patient must be using the device at least four hours per 24-hour period on at least 70% of days in each remaining paid rental month and any month in which accessories or supplies are dispensed.
The use of volume-targeted modes is not currently referenced in the RAD section but is discussed in the HMV coverage context. Questions remain around whether HME providers can use these modes in RAD devices if high intensity thresholds are met.
For HMVs:
Within six months:
- Must have four hours per 24-hour period on at least 70% of days in a 30-day period.
- The treating clinician must establish usage criteria are being met (this meeting is not required to be face
to face).
In seven to 12 months, the physician must establish the patient is using the device at least four hours per 24-hour period on at least 70% of days in each paid rental month.
After the second evaluation, the patient must be using the device at least four hours per 24-hour period on at least 70% of days in each remaining paid rental month.
Two Paths to Compliance
With the finalized NCD now in effect, HME providers have a decision to make: Either build internal infrastructure to manage ongoing compliance or partner with an organization that has done so.
Building in-house means hiring or reallocating clinical staff, developing documentation workflows, continually updating spreadsheets, integrating usage tracking with ventilator platforms and training teams on reevaluation timelines and CMS criteria. And that’s just the internal work. Your referral practices have no means to track these six-month cycles or collect the data to recertify. This approach offers full control, but it can be resource-intensive.
Outsourcing allows organizations to align with the new requirements using proven, scalable systems. Partner companies can offer a clinical resource management system dedicated to organizing and streamlining the process for physician practices. You gain the ability to automate compliance tracking, flag patients at risk of non-adherence, identify if clinical criteria has been met and generate physician-ready reports that meet CMS documentation standards.
Whichever option you choose, long-term success depends on the ability to manage patients proactively at scale. The new NCD isn’t just a policy update—it’s a fork in the road for the respiratory industry. Providers who embrace this shift will lead the charge into a future of accountable, high-quality care.