Stakeholders see hurdles, burdens in proposed decision on vents

WASHINGTON – Industry stakeholders are carefully weighing their response to CMS’s proposed decision on coverage for noninvasive home mechanical ventilators and respiratory assist devices, including asking the agency to pause implementation of the policy. 

CMS on March 11 released a proposed decision in response to the request to reconsider NCD 280.1 to establish coverage policies for the use of noninvasive HMV and RAD for Medicare beneficiaries with COPD.  

AAHomecare, at press time, was still reviewing the decision and discussing a potential letter to CMS, says Kim Brummett, senior vice president of regulatory affairs for AAHomecare. 

“There are a lot of operational hurdles proposed, in terms of requirements for suppliers,” she said. “In addition, there are challenges to the criteria and testing requirements.” 

The proposed decision expands coverage for RADs – with and without a backup rate feature – and removes the requirement that patients qualify with a sleep oximetry test. It also proposes coverage for HMVs in volume-targeted mode for individuals with chronic renal failure due to COPD who meet specific clinical criteria. 

‘Careful what you ask for’ 

However, the proposed decision also proposes several overly restrictive criteria, stakeholders say, such as requiring a minimum use of NIV/HMV of five hours within a 24-hour period to prove continued medical necessity. 

“The whole thing is pretty unclear, and if you look at the industry data we already have, I would say only about 50% to 60% of the patients that are on service today would qualify – not because they don’t need therapy, but because the qualifications are so strict,” said Zach Gantt, CEO of Encore Healthcare. “A lot of people have been asking for a policy for a long time, but I guess you’ve got to be careful what you ask for.” 

Certain patient monitoring requirements, like an arterial blood gas carbon dioxide reading, in the proposed decision could also serve to restrict patient access and place a heavy burden on suppliers, says Ronda Buhrmester, senior director of payer relations and reimbursement for VGM.  

“That’s an invasive test to do on a patient when there are other ways to look at CO2,” she said. “Taking care of the patient is the No. 1 priority, but from a payment perspective, we have additional burdens on the supplier, because they are now waiting on a patient to meet the compliance requirements.” 

‘Tiny, ancient studies’ 

One of the biggest issues stakeholders have with the proposed decision is that it seems to be based on older studies that aren’t up to date with current technologies and practices, they say. 

“They really lean heavily into studies to explain how they arrived at this, but the studies they chose are old, done between 1996 and 2016, they are all done in Europe and the total number in all four studies is only 603,” said Dr. William Frazier, chief medical officer at Viemed, who has published three studies analyzing Medicare claims to demonstrate the benefits of HMV. “These four tiny, ancient European studies aren’t really applicable to U.S. Medicare beneficiaries in 2025, so we’ve gotten some bad proposed coverage criteria.” 

‘Best shot’ 

CMS is soliciting public comment on the decision until April 10. The tight timeline, as well as the lack of comments specifically from post-acute care providers during the initial comment period in September, make it critical for the HME industry to get aligned on what the policy should look like, say stakeholders. 

“Our best shot is if we push back and have a united front on this whole thing,” said Gantt. “We haven’t done very good at that in the past. The short time period is a challenge, but we’re getting information and education out about it.” 

• Read CMS’s proposed decision memo here.  
• Submit comments on its decision here.