CMS’ final coverage policy for CPAP expands coverage for OSA diagnosed using a clinical evaluation plus a positive PSG, type II, type III, and type IV test measuring three or more channels. However, questions remain, such as: Who can do the studies? Who can order the studies? And what about type IV monitoring equipment with fewer than three channels?

“The thing that was the most surprising to me is that CMS said it is including category IV monitoring equipment, but then went on to say ‘with 3 or more channels for testing,’ said Helen A. Kent, RRT, president of Progressive Medical, Carlsbad, Calif. “A category IV monitoring device provides only single or dual bioparameter recording so, in reality, CMS is only accepting category I, II, and III monitoring equipment for home sleep testing. Is this a typo or do they not know the difference?”

For Joseph Lewarski [pictured], the answer to Kent’s question may be that CMS is relying on the market to adjust channels and ultimately adhere to the ruling. “In my opinion, CMS knows the device classes very well and the 3 channels is not a typo,” says Lewarski, vice president, respiratory group, for the Invacare Corp, Elyria, Ohio. “While it is true that some devices only have 1 or 2 channels, I think the market will see a third channel added to many devices to round out the IV devices. One of the arguments was that if pulse oximetry (which is 2 channels) is not acceptable, other 2 channel devices should not as well. However, they have allowed Watch-PAT, which is not really 3 channel. Again, in my opinion CMS is reinforcing their comments that there is not compelling evidence that any of the testing devices or methods are more accurate or diagnostic for OSA, and therefore approved essentially all.”

Reaction throughout the sleep community was predictably mixed. “If you’re talking about manufacturers of equipment, they are going to be thrilled,” said Henry L. Johns, BS, RPSGT, CRT, CPFT, director of sleep and respiratory services for Pulmonary & Sleep Associates of Topeka, Kan, as originally reported in this week’s Sleep Report, the sister newsletter of Friday Report. “If you’re talking about the people who are looking to make a fast buck off of Medicare, they are going to be thrilled. If you are talking about the sleep community and sleep physicians, they are not going to be quite so thrilled unless they are poised to jump into home testing.” 

For Johns, the decision to include type IV is problematic. “A type IV device just does not do enough,” he says. “Anyone with a modified oximeter can do a test. [Based on the CMS ruling] if their oximeter picks up oximetry data, heart rate data, and airflow, that’s enough. The AASM [American Academy of Sleep Medicine] was against the use of the type IV monitors. They did not think that was adequate.”

Sleep Report confirms that at least one insurer has posted a new clinical policy related to diagnosis of OSA. According to an Aetna bulletin, “Aetna considers any of the following diagnostic techniques medically necessary for members with symptoms suggestive of OSA: Full-channel nocturnal polysomnography (NPSG) (Type I device) performed in a healthcare facility; unattended home sleep monitoring using a Type II, III, or IV device. ...”

So far, CPAP providers do not know who can do the studies. There is also no word yet on coding or fees. Stay tuned with Friday Report and Sleep Report in the coming weeks for more information.