Newly released Medicare national coverage determinations are set to reshape the home ventilation landscape for chronic obstructive pulmonary disease (COPD).
The final determination of coverage released June 9 takes the long-awaited step of simplifying access to bilevel positive airway pressure (BiPAP) respiratory assist devices and restricts the more expensive home mechanical ventilators to only those who need the additional ventilatory modes and features they offer.
"There's definitely celebrating going on," said Lisa Wolfe, MD, of Northwestern University in Chicago and a member of the technical expert panel who worked on the recommendations to the Centers for Medicare and Medicaid Services (CMS).
"Because of the way the old guidelines were written, it was really easier to get a full noninvasive ventilator than it was to get a bilevel PAP. And because of that, a lot of COPD patients were getting these larger noninvasive ventilators -- and they are so much more expensive," she told MedPage Today.
The new regulations simplify the burden of proof for both types of devices. They don't have oxygen qualifications or require proof that a patient has tried and failed BiPAP, so "they can go straight to a vent if they need a significant amount of oxygen," Wolfe said.
Conversely, a patient qualifies for a BiPAP machine based on a blood gas test that shows high carbon dioxide (partial pressure of carbon dioxide ≥52 mm Hg by arterial blood gas during awake hours breathing the prescribed fraction of inspired oxygen), without the prior requirement of having to prove the patient had failed 2-L flow of oxygen or a formal sleep study to document that sleep apnea isn't the predominant cause of hypercapnia as long as the treating physician can attest to that.
The determination will expand the role of sleep labs in making decisions and titrating people on BiPAP beyond diagnoses of obstructive sleep apnea or central sleep apnea to now include COPD. "But the problem is it will significantly cut down access to respiratory therapy in the home," which has been tied to home mechanical ventilator rentals, Wolfe acknowledged.
"This has been a rather controversial area for a long time," said Nicholas Hill, MD, of Tufts University in Boston and a co-chair with Wolfe on the recommendations to CMS.
"As recently as 2013, [a Cochrane review] said that the evidence wasn't sufficiently clear to justify use more than on an investigational basis," he noted.
Key turning points were the publication of two trials proving benefit. A randomized trial from Germany and Austria among 195 stable GOLD stage IV COPD patients showed that use of a standard BiPAP-type machine substantially boosted survival. One-year mortality was 12% with the noninvasive PAP compared with 33% in the control group, a 76% relative reduction in risk (P=0.0004). The BiPAP group also gained an advantage in multiple measures of blood oxygenation and lung function, as well as health-related quality of life.
"Results for 6-min walk distance did not reach the predefined significance level, but the suggested minimal clinically important increase in 6-min walk distance of 54 m was reached by 45 (44%) patients in the intervention group versus 23 (25%) control patients," the authors wrote.
A subsequent study from the U.K. that randomized 116 COPD patients with persistent hypercapnia after recent resolution of respiratory acidemia to either home oxygen alone or with BiPAP-type home ventilation showed a longer median time to readmission or death (4.3 vs 1.4 months, adjusted HR 0.49, P=0.002) and a 17% absolute lower 12-month risk of readmission or death (63.4% vs 80.4%) with the added BiPAP. The difference was driven by a reduction in hospitalizations without a difference in mortality, "but they allowed crossovers, which generally is going to make it hard to show positive outcomes," Hill acknowledged.
Guidelines have shifted to recommend noninvasive home ventilation, and now the CMS regulations are in line with the science, Hill suggested.
"Both these positive studies used simple BiPAP-type devices, not these more expensive ones. And there really isn't any justification for CMS rules to encourage use of these more expensive ones as a first option," he told MedPage Today.
A big change was the creation of a pathway for hospitalized patients to go home with a BiPAP machine, although there are documentation requirements, Wolfe said. "In order to make that work, when a patient is in the hospital, the physicians will need to get an arterial blood gas, not a venous one, because the venous won't count. It has to be arterial. And they have to document that the patient is using the BiPAP machine and what the full settings of the machine are and that they are benefiting from that machine up to and including the last 24 hours that they're admitted to the hospital."
Patients who need more than 4 L of oxygen or who use their PAP machine more than 8 hours a day will still qualify for the "Cadillac" version, Wolfe added. "But other than that, they've made it so easy to get a standard BiPAP machine that you're not going to get the higher-end machine unless you have those significant problems."
The new national coverage determination goes into effect by September, and while it only covers COPD, not any other respiratory conditions for which patients might need respiratory assist devices, Wolfe noted that this additional national coverage determination is anticipated to be forthcoming.
A more intractable problem is getting patients on and using the devices.
"I don't think there's any question that people who would stand to benefit from this are not getting it," Hill said. Even in his own hospital, COPD patients on general medical services often don't get pulmonary consultations and thus typically are not offered noninvasive home ventilation. And of those who do get it, "many of them don't continue when they leave the hospital and not infrequently that's because they don't want to," he explained.
This older population often has comorbidities and socioeconomic and cognitive challenges that make them not good candidates or lead them to decline, Hill noted. Then, "a lot of people who are prescribed and even get to the point of receiving them at home are not going to use them as prescribed. You know, they end up in the closet."
After the first 6 months, continued coverage requires that the patient be using the device at least 4 hours per a 24-hour period on at least 70% of days and achieve some clinical benefit.
Disclosures
Wolfe disclosed no relevant relationships with industry.
Hill disclosed a research grant to his institution from Telesair.
