CQRC, INDUSTRY STAKEHOLDERS SEEK CLARIFICATIONS ON VENT POLICY
WASHINGTON, DC – The Council for Quality Respiratory Care (CQRC) joined stakeholder groups in sending a letter to the Centers for Medicare & Medicaid Services (CMS) urgently calling for clarifying guidance for the continuing use criteria for both home mechanical ventilators (HMV) and respiratory assist devices (RAD) used by Medicare beneficiaries with chronic respiratory conditions.
April 2026 is the month in which the first group of patients prescribed the devices must meet continuing use criteria set out under the National Coverage Decision (NCD).
Without clarification of the RAD and HMV continuing use requirements, the letter states that more than 50% of beneficiaries who rely on these devices would need to discontinue therapy and return their devices, according to an informal survey of suppliers, even if their physicians believe the devices remain medically necessary.
The letter also cites data showing that patients with chronic respiratory conditions who receive HMV therapy experience fewer emergency department visits, fewer hospitalizations, and lower mortality. Yet, a lack of clarification on the continuing use criteria for RAD and HMV – and the absence of technology on certain devices to track and report usage – may jeopardize patient access to physician-directed care.
The clarifications encouraged in the letter prompt CMS to update the NCD policy to ensure that patients who may have narrowly missed Medicare’s requirement or have valid clinical reasons for falling short of the equipment usage threshold within the specific 30-day period can still access the life-sustaining care they need. If a patient does not meet adherence requirements, physicians are expected to discontinue therapy despite potential benefits, while Medicare bars suppliers from billing or leaving the device in place, creating an untenable situation for stakeholders.
“The clarifications we request would support the Administration’s intent to ensure that patients prescribed RADs and HMVs are using and benefiting from the devices in the medical opinion of their physician,” the letter reads. “We supported the Administration’s adoption of many of the recommendations that patient advocates, physicians, respiratory therapists, suppliers, and manufacturers had suggested in the final NCD. However, the continuing use criteria clarifications were not addressed at that time.”
The letter presents potential long-term solutions, including a multi-month rolling average and further clarification on patient use of high-intensity settings for RAD Bi-level pressure capability, including whether sustained pressures greater than or equal to 15 cm H₂O during therapy are required to be documented or whether device settings configured to deliver pressures at or above this threshold are sufficient.
CQRC and its stakeholder partners urge the issuance of guidance that applies to all CMS audit contractors and clarifications to be issued before the end of April, so that patients can access medically required devices and benefit from them in the view of their physician.
Other groups signing the letter include the American Association for Respiratory Care, AAHomecare, COPD Foundation and VGM & Associates.