CMS's next step on vents is unclear

WASHINGTON - It was a first step, but CMS has more homework to do before it moves to establish a new national coverage determination for non-invasive positive pressure ventilation, say the members of the Medicare Evidence Development and Coverage Advisory Committee.

The members met virtually on July 22 to discuss clinical data to better define COPD patients who could benefit from NIPPV, usage criteria and equipment parameters, say industry stakeholders who listened in on the call.

“For me, (the committee wasn't) very confident that the evidence was clear,” said Kim Brummett, vice president of regulatory affairs for AAHomecare. “They didn't present a clear and concise opinion on how to move forward.”

Once CMS reviews MEDCAC's recommendations, it can: do nothing and stick with the current NCD for ventilators; issue a proposed new NCD, which could include other devices, and take public comments; or seek public comments and then issue a proposed new NCD.

The committee did agree there is a need for COPD patients to access the respiratory devices that are best suited for their condition. The problem is how to define which patients will benefit from home mechanical ventilation and other respiratory devices, including CPAP and RAD, say stakeholders.

“It's always been a clinical judgment,” said Cara Bachenheimer, head of the government affairs practice at Brown & Fortunato. “There are not necessarily clear demarcations where they benefit from one device vs. another. They basically need more data before they can move forward.”

The current NCD has been a sticking point for stakeholders for years.

A few years ago, several respiratory groups, including the American Association of Respiratory Care, asked the agency to reconsider the NCD. Most recently in March, the Council for Quality Respiratory Care backed a report from the Agency for Healthcare Research and Quality that found patients with COPD who used BiPAP devices experienced lower mortality, intubations and hospital admissions compared to COPD patients who did not use a device, while patients who used a home mechanical ventilation device experienced fewer hospital admissions overall.

“At the end of the day, I think most members of the MEDCAC agreed the policies that do exist are archaic,” Brummett said.