The Council for Quality Respiratory Care (CQRC) has joined other advocacy groups urging the Centers for Medicare & Medicaid Services (CMS) to immediately issue guidance on the continuing criteria for home mechanical ventilators (HMV) and respiratory assist devices (RAD) being used by Medicare beneficiaries who have chronic respiratory conditions.
“With the April 2026 implementation of the National Coverage Decision (NCD) for RAD and HMV devices, which includes rigid continuing use criteria, CQRC and leading patient and respiratory care groups are seeking immediate guidance,” CQRC said in an April 20 news announcement. “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 organization signed onto an April 16 stakeholder letter addressed to CMS Administrator Mehmet Oz, M.D., and CMS Deputy Administrator Kimberly Brandt, J.D. The American Association for Homecare, the American Association for Respiratory Care, the COPD Foundation, and VGM & Associates are currently the other groups that have signed the letter.
The letter “cites data showing that patients with chronic respiratory conditions who receive home mechanical ventilator 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.”
In the letter, the participating organizations noted that April 2026 is when the first group of RAD/HMV patients must demonstrate, according to the national coverage determination (NCD), that they will meet criteria for continuing the use of that equipment.
“Under the current NCD language, many patients narrowly miss the Medicare adherence requirement of greater than or equal to four hours per day on 70% of days within a single 30-day period,” the letter said. “Current NCD policy does not directly speak to what happens if a patient shows usage, but may have missed the rigid requirement or have valid clinical reasons for falling short of this threshold within a specific 30-day period.”
And as the letter pointed out, ordering physicians face no-win situations if patient adherence isn’t met.
“The NCD does not allow patients to remain on the device,” the letter noted. “Physicians will be asked to write orders discontinuing therapy for patents not meeting usage requirements. However, if the physician believes that the patient is benefiting from the device, it is not appropriate, ethical or consistent with their medical judgment to write the discontinuation order.”
Suppliers would also be placed in impossible predicaments. “Medicare prohibits suppliers from continuing billing,” the letter said. “Nor are suppliers permitted to leave the device in the home, as doing so would constitute providing non-covered services.”
The letter noted that using “a multi-month rolling average similar to policies in other parts of the Medicare programs might be appropriate” as a longer-term solution, but added “beneficiaries, prescribers and suppliers need clarity now — in April 2026 — to prevent beneficiaries being told they must return their devices.
“Specifically, we ask that CMS issue a clarification in writing that allows the prescriber of the RAD or HMV device to certify that the patient’s continued use of the device is medically appropriate if the patient’s actual usage in the 30-day period is less than the NCD requirement. Additionally, CMS should accept a statement from the patient that they continue to use the device at least four hours a day when signed by the physician.”
The letter also requested clarification related to patient use of high-intensity settings for “RAD bi-level pressure capability, with back-up rate feature” devices.
“It is currently unclear whether qualification for ongoing use requires documentation of sustained pressures greater than or equal to 15 cm H2O during therapy or whether device settings configured to deliver pressures at or above this threshold are sufficient,” the letter said.
“We recommend that CMS clarify that the requirement is met if the device provided is programmed to deliver inspiratory pressures of 15 cm H2O or higher, satisfying the high-intensity settings criteria.”
