WASHINGTON—Several advocacy organizations and patient groups penned a letter to the Centers for Medicare & Medicaid Services (CMS) Administrator Mehmet Oz requesting immediate clarification on guidance for the continuing‑use criteria for home mechanical ventilators (HMVs) and respiratory assist devices (RADs) for beneficiaries with chronic respiratory failure due to chronic obstructive pulmonary disease (COPD).
"Medicare beneficiaries rely upon this respiratory equipment to remain in their homes and communities while receiving this life-sustaining therapy," the letter said. "Despite nearly a year of outreach and engagement with the CMS contractors and staff, there has been no clarification of these requirements. As a result, based on an informal survey of suppliers potentially more than 50% of beneficiaries relying on HMV and RAD devices will be required to end their therapy and return their devices, even if their physicians believe the devices remain medically necessary. We need CMS to act now to protect patients’ access to these devices."
The letter continued that the clarifications requested would support the administration’s publicly expressed intent to ensure that patients prescribed RADs and HMVs are using and benefiting from the devices in the medical opinion of their physician.
"Under the current NCD [National Coverage Determination] 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."
The American Association for Homecare (AAHomecare) released its own statement regarding the letter in its newsletter.
"For nearly a year, the American Association for Respiratory Care, the Council for Quality Respiratory Care, VGM, the COPD Foundation and AAHomecare have engaged CMS contractors seeking clarification," AAHomecare said. "In the absence of clear guidance, informal supplier surveys show that more than 50% of beneficiaries using HMVs or RADs could be required to return their equipment and discontinue therapy, even when their physicians believe it is medically necessary."
In a separate letter, the American Thoracic Society noted that while adherence metrics can help guide early therapy, strict adherence to these thresholds does not reflect the clinical course of COPD. They emphasized that patients often experience variable tolerance during the first six months of therapy and that a single month of sub‑threshold use during the maintenance phase should not trigger loss of coverage.
The letter also requests clarification on the threshold requirement for high‑intensity settings for RAD Bi‑level Pressure Capability devices with a back‑up rate.
You can access the stakeholder letter here.