CMS proposal increases visibility of multi-function vents

WASHINGTON - In an unexpected move, CMS has proposed establishing fee schedule amounts specific to multi-function ventilators, but the manufacturer of what's believed to be the only such device currently on the market has declined to comment publicly.

In a recently released proposed rule, CMS proposes to establish fee schedule amounts for multi-function vents based on the current Medicare fee schedules for vents, plus an additional amount for the average cost of the various additional functions or features the device offers, starting Jan. 1, 2019.

In April of last year, Ventec Life Systems received FDA 510(k) clearance from the U.S. Food and Drug Administration for its VOCSN, a device that combines five respiratory therapies: ventilation, oxygen, cough, suction and nebulization. The device has been available in a controlled rollout, with wider distribution set for late 2018, early 2019.

Unlike multi-mode vents—devices that provide ventilation and bi-pap therapy—the VOCSN combines separate DME into one device that would, otherwise, fall under separate fee schedules, company officials say.

“Concerns have been raised by the manufacturer of a multi-function ventilator about how the separate payment categories would apply to a new type of ventilator,” CMS wrote in the rule.

When reached by HME News, company officials at Ventec said they were still teasing apart the 10 pages of the 368-page proposed rule dedicated to multi-function vents.

Other stakeholders, however, say they are surprised, with all the work that needs to be done to better define Medicare's policies for vents, that CMS would make this a priority.

“The irony is that there have been 'multi-function' vents that provide non-invasive ventilation and bi-pap therapy on the market for six years, and we've been screaming for Medicare to give us clearer medical guidelines for them,” said Max Hoyt, vice president of government relations for provider Viemed. “There's a real need for that.”

The need for a vent that provides more than ventilation and bi-pap therapy is not as great, stakeholders say.

“It looks like it's strictly for ALS patients,” said Tyler Riddle, CEO for provider MRS Homecare. “That would be the only disease state that would qualify a patient for so many different therapies. I do see the benefit of having one piece of equipment, but it would have to be cost effective to provide it rather than legacy equipment.”

The device can be configured for all therapies or a mix of therapies, and is designed to improve care for patients with neuromuscular disease, impaired lung function, spinal cord injury and pediatric development complications, company officials say.

The cost effectiveness of a multi-function vent is a big question for some stakeholders, who believe whatever add-on reimbursement CMS provides will not cover the costs of the more-expensive device.

“You're not going to put a whole vitals cart in the home because a patient needs to check their blood pressure every day,” Hoyt said. “You're going to give them a $30 cuff, not the $1,000 cart, even though some day down the road they might need it.”

Big picture, however, stakeholders applaud CMS for proposing new policies that reflect the need for increased integration in health care.

“It's a very cool concept—for the right patient,” said Chris Rice, CEO of provider Diamond Respiratory. “I'm impressed by their ability to get it included in this rule. It's also the first innovation we've seen in awhile.”