CMS nixes new sleep codes

Saturday, January 31, 2004

BALTIMORE - In a decision issued late last year, CMS rebuffed the sleep industries latest attempts to create billing codes for new technologies
CMS won't budge on a code for Auto CPAP like ResMed's AutoSet Spirit.

A group of sleep manufacturers, led by ResMed, failed again to win a new code for auto CPAP, a middle-ground technology between CPAP and bi-level CPAP.

Respironics, not unexpectedly, failed to win a new code for its C-Flex CPAP but beat back some interest from CMS’s Alpha-Numeric Work Group that would have coded C-Flex as a bi-level CPAP, a potentially disastrous fate for the popular new technology. Instead, CMS has coded C-Flex as a CPAP device, which preserves the technology’s place in the marketplace today.

CMS also has denied a request to create a code for a premium sleep mask.

Auto CPAP’s boosters have been pushing for a code for about six years, ever since the product entered the market as an alternative to both CPAP and bi-level CPAP. While CPAP provides continuous pressure and bi-level provides two levels of pressure, higher upon inhalation and lower upon exhalation, Auto CPAP responds to a sleeper’s flow limitations, snoring and apneas to adjust the level of pressure delivered.

Today, patients who can’t tolerate CPAP often move on to bi-level CPAP. About 10% of all CPAP users are on bi-level.

“If you are jumping patients from CPAP to bi-level and you are spending more money, why not have an interim product where they have to fail CPAP and then go to an auto-setting device, which may be more therapeutically beneficial to a patient than putting them on bi-level,” said Ron Richard, vice president of marketing at ResMed.

If CMS had granted a code for Auto CPAP, the expectation was that reimbursement would have come in somewhere between CPAP and bi-level.

CMS did not state its reasons for denying a code for Auto CPAP.

“There are a lot of theories,” said Rich Kocinski, vice president and general manager of respiratory for Sunrise Medical’s DeVilbiss division. “Did we not prove clinical effectiveness, or clinical necessity, and of course there is always healthcare costs.”

Whatever the reason, Richard and company are seeking an appointment to pursue the issue with CMS’s coding group this month, or next. In the meantime, they’re reminded of the pressure exerted between a rock and a hard place - between the desire, as manufacturers, to push the technology envelope and the frustration of providers who don’t want manufacturers to make anything that can’t get coded.

Everybody asks for new technology, but at the same time if you come out with something that is better for a patient but costs more and you can’t get reimbursed, you are really in a bind,” said Kocinski.

Richard would like to see CMS address rejections the way the FDA does when it denies marketing clearance for new products.

“CMS has to step up and give manufacturers better direction on how you get through the hurdles or the maze of reimbursement questions in order to be successful in securing payment for something because it is frustrating for the dealers, the patients and the doctors,” he said.