NIV reconsideration: Try-and-fail recommendation causes concerns

WASHINGTON – Industry stakeholders are concerned that a recommendation to require COPD patients to try and fail on respiratory assist devices before they can qualify for non-invasive ventilators will impede access for patients. 

The recommendation is part of a request to reconsider the national coverage determination for the use of non-invasive ventilators and respiratory assist devices for Medicare beneficiaries with COPD. 

It would be better to first deal with existing issues surrounding RAD devices and clarifying and simplifying their coverage, says Kim Brummett, senior vice president of regulatory affairs for AAHomecare. 

“A lot of patients are on NIV because it works for them and qualifying for a RAD is incredibly complicated,” she said. “Our biggest fear is that they are going to narrow the criteria and then we don’t have a revision to the RAD LCD and these patients are really caught between a rock and a hard place and can’t get anything.” 

The request to reconsider the NCD for the use of NIV and RAD was made by The Optimal Noninvasive Ventilation Medicare Access Promotion Technical Expert Panel (TEP), which comprises representatives from the American College of Chest Physicians, the American Academy of Sleep Medicine, the American Association for Respiratory Care, and the American Thoracic Society.  

The request also includes a recommendation for 24/7 clinical support, a mandate that could be difficult to meet, says Ronda Buhrmester, senior director of payer relations and reimbursement for VGM. 

“A lot of suppliers do that anyway when ventilators are involved but to mandate that is a different situation,” she said. “They are asking for RTs to be available to do clinical assessments, but there’s already a shortage of RTs in health care. And also, will we get reimbursed for that? We currently don’t.” 

While stakeholders say they are still digesting the request, which CMS published on Sept. 11 with a comment deadline of Oct. 11, they say it’s important to be aligned on the issue, within the industry and, to the extent that it’s possible, with other stakeholders. 

“We don’t want to get into wordsmithing the medical records and making it subjective criteria,” Brummett said. “Just make sure it’s objective criteria that everybody knows – the prescribers, the suppliers – whether the patient qualifies or not and to be conscientious of those patients who are on NIV that may not meet coverage criteria in a revision.”